Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot

The goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot intervention.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Other: Whole Blood Fibrin Clot

Detailed Description

Patient outcomes after rotator cuff repair vary greatly and depend on the size of the tear itself. Researchers have identified a number of devices that can be used to reinforce the surgical repair and enhance the structure and function of both the muscles and tendons (Jo et al., 2011; Randelli, Arrigoni, Ragone, MEng, Aliprandi, Cabitza, 2011; Proctor, 2014). Reinforcement patches have been used to help improve surgical outcomes, including: allograft rotator cuff, human cadaveric skin, pig and bovine skin, equine pericardium, and porcine intestinal submucosa (Randelli, Arrigoni, Ragone, MEng, Aliprandi, Cabitza, 2011). Although synthetic patches have also shown some effectiveness, these patches do not provide biologic augmentation of the tendon repair (Jo et al., 2011).

Additionally, there has been some research examining the effectiveness of using platelet-rich plasma therapy to help repair both rotator cuff tendinopathy and tears. Platelets play an important role in the healing process and it has been theorized that exposing inflamed or healing tissue to higher densities of platelets can contribute to less pain, better range of motion (ROM), and overall healing (Pandey et al., 2016). The consensus on this type of therapy has shown inconclusive results, however. For example, research by Jo et al. (2011) found no significant change in clinical recovery in respect to pain or ROM compared to a control group. Alternatively, Pandey et al. (2016) found significant improvements in both pain and ROM scores as well as decreased re-tear rates in the plasma-rich protein treatment group. These and other similar studies utilized different methodologies for patient populations (tendinopathy versus full tears, etc.), treatment timing, formulation of platelet-rich plasma or whole blood fibrin clot, and time of follow-up. Further research is needed to identify what treatments, if any, in the field of platelet-rich plasma are most beneficial for patients with rotator cuff tears. Recent research has demonstrated that whole blood fibrin clots concentrate 98% of available platelets and release growth factors including vascular endothelial growth factor over two weeks (Siegel, Clevenger, Proctor, Clegg, & Proctor, 2017). However, clinical evidence indicating the effect of whole blood fibrin clots on the healing of repaired torn rotator cuffs is lacking (Jo et al., 2011). The goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot intervention.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93101
      • De La Vina Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1) Presence of ultrasonographic or magnetic resonance imaging (MRI) documented rotator cuff tear confirmed at surgery to be a medium to large-sized rotator cuff tear (> 1 cm), which requires intervention due to persistent difficulty in elevation of affected shoulder and/or pain; 2) ability to give informed consent for procedure, rehabilitation, and regular clinical and radiologic follow-up for a minimum period of 6 most post-surgery; and have 3) preoperative blood platelet counts >150,000/microliter.

Exclusion Criteria:

1) they have a type III subscapularis tear and above due to different rehabilitation protocol; 2) massive, partial, or traumatic cuff tears; 3) partial or incomplete repairs; 4) is a chronic smoker or patient with Parkinson's disease; 5) have a condition that may hinder healing or attending follow-up visits (e.g., diabetes, immunocompromised status, chemotherapy treatment, chronic steroid use); and 6) age >70.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients in the control arm will receive standard of care for their rotator cuff tear, and will not receive the additional whole blood fibrin clot.
Experimental: Treatment; Patients in the control arm will receive standard of care for their rotator cuff tear, in addition to, the whole blood fibrin clot.	Other: Whole Blood Fibrin Clot; For all patients assigned to the treatment group, 35mL of whole blood will be obtained during surgery by an anesthesiologist. 5 mL of the blood will be sent for pre-clot formation cell count evaluation for platelets, red blood cells and white blood cells. The remaining 30mL will be placed into a sterile container with a sintered glass cylinder supported by the lid for fibrin clot formation. The clot formation cups will be placed on a rotator at room temperature for 10 minutes at 125rpm. The fibrin clot will be removed and 5mL of the post-clot serum sent for post-clot formation cell count evaluation for platelets, red blood cells, and white blood cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascularity Index	Vascularity or the structural outcome will be assessed at 6 weeks postoperatively using the vascularity index scoring system described in Zumstein et al., (2014).	Assessed 6 weeks postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	A 10-point pain scale for pain at night, with 0 being no pain and 10 being unbearable.	Assessed at baseline and at 1 week, 3 weeks, and then at 3 and 6 months.
Western Ontario Rotator Cuff Index	A 21 - item questionnaire that measures quality of life for patients with rotator cuff disease.	Assessed at baseline, and 3 and 6 months.
Veterans Rand (VR-12)	A generic quality of life measure that consists of 12 items.	Assessed at baseline, and 3 and 6 months.
American Shoulder and Elbow Surgeons Score (ASES)	A 100-point scale which measures pain (up to 50 points) and function (up to 50 points). A higher score indicates less pain and better function.	Assessed at baseline and at 3 and 6 month.
Single Assessment Numeric Evaluation Score (SANE)	A single -item questionnaire that asks "What percentage of normal is your shoulder?" A rating scale from 0% to 100% is given with higher being better.	Assessed at 3 and 6 months.

Collaborators and Investigators

• Sponsor: Santa Barbara Cottage Hospital

Publications and helpful links

General Publications

• Proctor CS. Long-term successful arthroscopic repair of large and massive rotator cuff tears with a functional and degradable reinforcement device. J Shoulder Elbow Surg. 2014 Oct;23(10):1508-13. doi: 10.1016/j.jse.2014.01.010. Epub 2014 Apr 13.
• Proctor CS. Rotator cuff repair augmented with endogenous fibrin clot. Arthrosc Tech. 2012 May 18;1(1):e79-82. doi: 10.1016/j.eats.2012.03.002. Print 2012 Sep.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): April 25, 2022

Study Registration Dates

• First Submitted: June 23, 2018
• First Submitted That Met QC Criteria: June 23, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Rotator cuff repair, whole blood fibrin clot
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 17-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Results on the aggregate of the sample will be published.

Drug and device information, study documents

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