LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair

Extracellular Matrix Scaffold Graft Augmentation in Rotator Cuff Repair: a Prospective, Randomized, Controlled Trial

This trial is to evaluate the effectiveness of the ArthroFLEX® ECM scaffold graph as an augment in rotator cuff repair surgery to reduce the failure rate of rotator cuff repairs for large and massive rotator cuff tears.

Study Overview

• Status: Terminated
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: Control; Procedure: ArthroFLEX ECM scaffold graft; Biological: Alternative Treatment Group

Detailed Description

This is a prospective, randomized, controlled, multi-center clinical trial to evaluate the effectiveness of an ECM scaffold graft to augment repair of a large/massive rotator cuff tear. The study will involve 70 patients. 35 patients will be randomly assigned to each arm of the study.

Despite advances in surgical technology, repairs of large (3-5 cm) and massive (>5 cm) rotator cuff tears (RCT) fail between 20%-90% of the time [1]. Due to their size and increased structural involvement, large or massive RCT present a substantial challenge to orthopaedic surgeons. [16] The repairs tend to fail at the suture-tendon junction, which is due to several factors, including tension at the repair and quality of the tendon [1-2,5]. Full thickness tears are uncommon in younger patients, especially those less than forty years old and are usually traumatic in etiology. Younger patients also typically fair better following arthroscopic rotator cuff repair with fewer failures and more successful return to pre-injury level of function [16]. One strategy to augment repair of large to massive rotator cuff tears has been the development of biological scaffold materials, which are composed of extracellular matrix (ECM). The ECM composing the scaffolds are made from a number of tissues, including, but not limited to, small intestinal submucosa (SIS), dermis, and pericardium [3]. Studies to date include both prospective and retrospective in animal and human models, and include Restore, a porcine-derived SIS by DePuy Orthopaedics, GraftJacket, a human-derived, non-cross-linked dermis graft by Wright Medical Technology, and Zimmer Collagen Repair, a cross-linked porcine derived dermal graft made by Zimmer. Restore studies have shown no benefit and some even an increase in repair failure with recommendations not to use to augment repair. GraftJacket studies have shown a reduction in graft failure; however, several of the Restore and GraftJacket studies are limited by a lack of a control cohort. The Zimmer graft studies have conflicting results with both an improvement and no improvement in failure rates of repair. The prior studies listed are all in vivo; however, the majority are not randomized trials and thus do not have a control with which to compare data. In addition, some trials include open repairs. A lack of prospective, randomized, controlled, in vivo trials exist that evaluate the ability of the ECM scaffold graft augmentation in large to massive arthroscopic rotator cuff repairs to decrease the failure rate.

The purpose of this study is to evaluate the efficacy of using the Arthroflex (A-FLEX) graft to augment large to massive arthroscopic rotator cuff repairs in vivo and decrease repair failures in a prospective, randomized, controlled trial. By undergoing serial US examinations at follow-ups, we also intend to evaluate when during the postoperative period the failure of the repair occurs.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with a large (2.5-5 cm) to massive (>5 cm) rotator cuff tear who will be undergoing open or arthroscopic repair. The cuff tear size will be determined on either pre-operative magnetic resonance imaging (MRI), or ultrasound (US), or intra-operative measurements, or computerized tomography (CT).
• Patients who are willing and able to provide written informed consent for their involvement in the study.
• Patients who meet criteria for RCR surgery
• Patients older than 18 years of age

Exclusion Criteria:

• Those with a known sensitivity to materials of porcine origin.
• Patients with addiction to illegal drugs, solvents or alcohol who are actively using or have previously attempted and failed a treatment program.
• Patients with bacteremia, a systemic infection, or infection of the surgical site.
• All those who are prisoners.
• Patients who are pregnant or nursing.
• All those with a condition that may limit a patient's ability to finalize the study or that may cause an undue risk to the patient's health and well-being.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Treatment Group; Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used.	Procedure: Control; This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.; Other Names: Surgery without ECM graft
Active Comparator: Treatment Group; Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff.	Procedure: ArthroFLEX ECM scaffold graft; In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.; Other Names: Surgery with ECM graft
Other: Alternative Treatment Group; Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.	Biological: Alternative Treatment Group; Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.; Other Names: Repair cannot be accomplished

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tendon Healing	Success as defined by tendon healing after rotator cuff repair, as indicated based on MRI	As assessed 1 year postoperatively.
Comparison of Healing by MRI vs US	Comparison of tendon healing will be assessed using US imaging modalities versus MRI (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)	As assessed 1 year postoperatively.
Progress of Tendon Healing	Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)	As assessed at 6 weeks postoperatively.
Progress of Tendon Healing	Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)	As assessed at 3 months postoperatively.
Progress of Tendon Healing	Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)	As assessed at 6 months postoperatively.
Progress of Tendon Healing	Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)	As assessed at 9 months postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.	Preoperative
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.	6 weeks after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.	3 months after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.	6 months after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.	9 months after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.	1 year after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.	Preoperative
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.	6 weeks after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.	3 months after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.	6 months after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.	9 months after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.	1 year after surgery
Patient Outcomes: Measurement of Shoulder Activity Level	This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.	Preoperative
Patient Outcomes: Measurement of Shoulder Activity Level	This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.	6 weeks after surgery
Patient Outcomes: Measurement of Shoulder Activity Level	This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.	3 months after surgery
Patient Outcomes: Measurement of Shoulder Activity Level	This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.	6 months after surgery
Patient Outcomes: Measurement of Shoulder Activity Level	This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.	9 months after surgery
Patient Outcomes: Measurement of Shoulder Activity Level	This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.	1 year after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)	The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.	Preoperative
Patient Outcomes: Subjective Shoulder Value (SSV)	The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.	6 weeks after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)	The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.	3 months after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)	The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.	6 months after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)	The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.	9 months after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)	The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.	1 year after surgery
Patient Outcomes: Constant Score (CS)	C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.	Preoperative
Patient Outcomes: Constant Score (CS)	C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.	6 weeks after surgery
Patient Outcomes: Constant Score (CS)	C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.	3 months after surgery
Patient Outcomes: Constant Score (CS)	C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.	6 months after surgery
Patient Outcomes: Constant Score (CS)	C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.	9 months after surgery
Patient Outcomes: Constant Score (CS)	C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.	1 year after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	Preoperative
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	6 weeks after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	3 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	6 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	9 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	1 year after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	Preoperative
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	6 weeks after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	3 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	6 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	9 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.	1 year after surgery

Collaborators and Investigators

• Sponsor: Gregory Gilot
• Collaborators: The Cleveland Clinic; LifeNet Health
• Investigators: Principal Investigator: Gregory J Gilot, MD, Cleveland Clinic Florida

Publications and helpful links

General Publications

• Derwin KA, Badylak SF, Steinmann SP, Iannotti JP. Extracellular matrix scaffold devices for rotator cuff repair. J Shoulder Elbow Surg. 2010 Apr;19(3):467-76. doi: 10.1016/j.jse.2009.10.020. Epub 2010 Feb 26.
• Schlegel TF, Hawkins RJ, Lewis CW, Motta T, Turner AS. The effects of augmentation with Swine small intestine submucosa on tendon healing under tension: histologic and mechanical evaluations in sheep. Am J Sports Med. 2006 Feb;34(2):275-80. doi: 10.1177/0363546505279912. Epub 2005 Oct 6.
• Badylak SF, Freytes DO, Gilbert TW. Extracellular matrix as a biological scaffold material: Structure and function. Acta Biomater. 2009 Jan;5(1):1-13. doi: 10.1016/j.actbio.2008.09.013. Epub 2008 Oct 2.
• Sclamberg SG, Tibone JE, Itamura JM, Kasraeian S. Six-month magnetic resonance imaging follow-up of large and massive rotator cuff repairs reinforced with porcine small intestinal submucosa. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):538-41. doi: 10.1016/j.jse.2004.03.005.
• Iannotti JP, Codsi MJ, Kwon YW, Derwin K, Ciccone J, Brems JJ. Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears. A randomized, controlled trial. J Bone Joint Surg Am. 2006 Jun;88(6):1238-44. doi: 10.2106/JBJS.E.00524.
• Walton JR, Bowman NK, Khatib Y, Linklater J, Murrell GA. Restore orthobiologic implant: not recommended for augmentation of rotator cuff repairs. J Bone Joint Surg Am. 2007 Apr;89(4):786-91. doi: 10.2106/JBJS.F.00315.
• Zheng MH, Chen J, Kirilak Y, Willers C, Xu J, Wood D. Porcine small intestine submucosa (SIS) is not an acellular collagenous matrix and contains porcine DNA: possible implications in human implantation. J Biomed Mater Res B Appl Biomater. 2005 Apr;73(1):61-7. doi: 10.1002/jbm.b.30170.
• Bond JL, Dopirak RM, Higgins J, Burns J, Snyder SJ. Arthroscopic replacement of massive, irreparable rotator cuff tears using a GraftJacket allograft: technique and preliminary results. Arthroscopy. 2008 Apr;24(4):403-409.e1. doi: 10.1016/j.arthro.2007.07.033.
• Badhe SP, Lawrence TM, Smith FD, Lunn PG. An assessment of porcine dermal xenograft as an augmentation graft in the treatment of extensive rotator cuff tears. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):35S-39S. doi: 10.1016/j.jse.2007.08.005.
• Soler JA, Gidwani S, Curtis MJ. Early complications from the use of porcine dermal collagen implants (Permacol) as bridging constructs in the repair of massive rotator cuff tears. A report of 4 cases. Acta Orthop Belg. 2007 Aug;73(4):432-6.
• Brophy RH, Beauvais RL, Jones EC, Cordasco FA, Marx RG. Measurement of shoulder activity level. Clin Orthop Relat Res. 2005 Oct;439:101-8. doi: 10.1097/01.blo.0000173255.85016.1f.
• Parnes N, Bartoszewski NR, Defranco MJ. Arthroscopic Repair of Full-Thickness Rotator Cuff Tears in Active Patients Younger Than 40 Years: 2- to 5-Year Clinical Outcomes. Orthopedics. 2018 Jan 1;41(1):e52-e57. doi: 10.3928/01477447-20171114-02. Epub 2017 Nov 21.
• Chung SW, Kim JY, Kim MH, Kim SH, Oh JH. Arthroscopic repair of massive rotator cuff tears: outcome and analysis of factors associated with healing failure or poor postoperative function. Am J Sports Med. 2013 Jul;41(7):1674-83. doi: 10.1177/0363546513485719. Epub 2013 Apr 30.
• Greenspoon JA, Petri M, Warth RJ, Millett PJ. Massive rotator cuff tears: pathomechanics, current treatment options, and clinical outcomes. J Shoulder Elbow Surg. 2015 Sep;24(9):1493-505. doi: 10.1016/j.jse.2015.04.005. Epub 2015 Jun 28.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Rotator Cuff Tear; Extracellular Matrix; Large Rotator Cuff Tear; Massive Rotator Cuff Tear; ECM; ArthroFLEX
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: FLA 18-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No