Treatment of Partial-Thickness Rotator Cuff Tears (REGEN PUB 2018)

Prospective Multi-center Study Comparing REGENETEN in Lieu of Standard Arthroscopic Repair of High-grade (>50%) Partial-thickness Tears

The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears.

Study Overview

• Status: Terminated
• Conditions: Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
• Intervention / Treatment: Device: REGENETEN™ Bioinductive Implant; Device: Arthroscopic repair of the high-grade (>50%) partial-thickness

Detailed Description

The objective of this study is to demonstrate arthroscopic surgical treatment of high-grade (>50%) partial-thickness tears using REGENETEN yields statistically superior patient post-operative recovery outcomes, faster return to activities of daily living, and less health care utilization versus standard surgical repair techniques.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • University of Florida Orthopaedics and Sports Medicine
    • Jacksonville Beach, Florida, United States, 32250
      • Baptist Health
  • Georgia
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center/Luminis Health
  • New York
    • DeWitt, New York, United States, 13214
      • Syracuse Orthopedic Specialist
    • New York, New York, United States, 10032
      • Columbia University
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Orthopedic Associates of SW Ohio
  • Texas
    • Bedford, Texas, United States, 76021
      • Texas Orthopedic Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients will be considered qualified for enrollment if they meet the following criteria:

1. Male or female ≥18 years
2. High-grade (>50% tendon thickness) partial-thickness tear

3. Failed conservative medical management of the tendon tear defined as:

   1. Four (4) to six (6) weeks of formal physical therapy or guided home exercises
   2. Activity modification
   3. Shoulder injection at the discretion of the surgeon
4. Able to comply with the post-operative physiotherapy and follow-up schedule
5. Able to speak and read English Provide written informed consent

Exclusion Criteria:

Any one (1) of the following criteria will disqualify a patient from participation in the study:

1. Prior shoulder surgery on index shoulder within 12 months of enrollment
2. Failed primary rotator cuff surgery of the index shoulder
3. On steroids within 1 month of enrollment
4. Metastatic disease
5. Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP)
6. Concomitant biceps tenodesis
7. Rheumatoid arthritis
8. Advanced osteoarthritis
9. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
10. Chronic pain disorders (i.e., fibromyalgia)
11. History of insulin dependent diabetes
12. History of heavy smoking (> 1 pack per day) within 6 months of enrollment
13. Currently involved in any injury litigation or workers compensation claims
14. Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: REGENETEN™ Bioinductive Implant; Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.	Device: REGENETEN™ Bioinductive Implant; The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
Other: Arthroscopic repair of the high-grade (>50%) partial-thickness; Surgical treatment of partial-thickness rotator cuff tears using standard techniques.	Device: Arthroscopic repair of the high-grade (>50%) partial-thickness; Surgical treatment of partial-thickness rotator cuff tears using standard techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons (ASES) Score	American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery	American Shoulder and Elbow Surgeons (ASES) score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.	Baseline, Week 1, Week 2,Week 3,Week 4,Week 5,Week 6,Week 7,Week 8,Week 9,Week 10,Week 11, & Week 12
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery	Single Assessment Numeric Evaluation (SANE) score at baseline and weekly up to 12 weeks (3 months). SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery	Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome).	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months	American Shoulder and Elbow Surgeons (ASES) score at baseline, 6, 12, 18 and 24 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.	Baseline, 6 months, 12 months, 18 months and 24 months
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months	Single Assessment Numeric Evaluation (SANE) score at baseline, 6, 12, 18 and 24 months following index surgery. SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''	Baseline, 6 months, 12 months, 18 months and 24 months
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months	Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline, 6, 12, 18 and 24 months following index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome).	Baseline, 6 months, 12 months, 18 months and 24 months
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months	Constant-Murley Score at baseline, 3, 6, 12, and 24 months following index surgery. The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The test is divided into four subscales: pain, activities of daily living, strength, and range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder). Constant-Murley Scores range from 0 to 100, with higher scores indicating better shoulder function & lower scores indicating worse shoulder function.	Baseline, 3 months, 6 months, 12 months, and 24 months
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery	Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.	Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery	Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.	Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months	Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.	Directly after surgery, 6 months, and 12 months
Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months	Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.	Directly after surgery, 6 months, and 12 months
Duration of Shoulder Immobilization	Duration of shoulder immobilization measured as days spent in a sling	Following index surgery, up to 7 weeks
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery	Participants ability to return to previous type of work within 12 months post-index surgery was measured by the number of participants work status. Work status was identified as "Not currently employed", "Did not return to work", "Returned to partial, modified, or parttime employment", or "Returned to fulltime employment." The type of work for each work status (excluding "Not currently employed") was then categorized as: Very heavy work; Heavy work; Medium work; Light work; Sedentary work	Up to 12 months
Time to Return to Driving	Time to return to driving post-index surgery measured in days.	Following index surgery, up to 139 days
Time to Return to Sports	Time to return to sports involving overhead throwing post-index surgery measured in days.	Following index surgery, approximately 1 year
Number of Participants With Progression to Full-Thickness Tear at 12 Months	The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following: Tendinosis; Low-grade Partial Thickness Tear; High-grade Partial Thickness Tear; Full-Thickness Tear; Intact	12 months
Number of Participants With Progression to Full-Thickness Tear at 24 Months	The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following: Tendinosis; Low-grade Partial Thickness Tear; High-grade Partial Thickness Tear; Full-Thickness Tear; Intact	24 months
Number of Participants Percent Filling of Rotator Cuff at 12 Months	The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 12 months post-index surgery as bursal (Yes/No), then categorized as one of the following: 0% to < 25%; 25% to < 50%; 50% to < 75%; 75% to <100%; 100%	12 months
Number of Participants Percent Filling of Rotator Cuff at 24 Months	The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 24 months post-index surgery as bursal (Yes/No), then categorized as one of the following: 0% to < 25%; 25% to < 50%; 50% to < 75%; 75% to <100%; 100%	24 months
Rotator Cuff Tendon Thickness at 12 Months	Rotator cuff tendon thickness in millimeters (mm) at 12 months post-index surgery categorized as: Total Thickness (where tendon thickness cannot be differentiated); Thickness of Native (where tendon thickness can be differentiated); Thickness of New Tissue (where tendon thickness can be differentiated); Total Thickness (where tendon thickness can be differentiated)	12 Months
Rotator Cuff Tendon Thickness at 24 Months	Rotator cuff tendon thickness in millimeters (mm) at 24 months post-index surgery categorized as: Total Thickness (where tendon thickness cannot be differentiated); Thickness of Native (where tendon thickness can be differentiated); Thickness of New Tissue (where tendon thickness can be differentiated); Total Thickness (where tendon thickness can be differentiated)	24 Months
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months	The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: Grade 1; Grade 2; Grade 3; Grade 4; Grade 0	12 months
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months	The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: Grade 1; Grade 2; Grade 3; Grade 4; Grade 0	24 months
Number of Participants Sugaya Score of Rotator Cuff at 12 Months	The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: Type I; Type II; Type III; Type IV; Type V	12 months
Number of Participants Sugaya Score of Rotator Cuff at 24 Months	The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following: Type I; Type II; Type III; Type IV; Type V	24 months
Number of Participants With Revision Surgery	Incidence of revision surgery measured by the number of participants with Revision Surgery (Yes/No) defined as any revision surgery involving the index shoulder for any cause within 24 months post-index surgery.	Following index surgery, up to 24 months
Aggregate Health Care Utilization Costs	Related health care utilization costs over 12 months post- surgery will be calculated based on health care utilization as reported in the participant diary and/or in the participant's medical records.	Following index surgery, up to 12 months
Operating Room Time (Index Surgery)	Operating time for the index surgery, defined as the time from first incision to wound closure (measured in minutes) as recorded in the operative procedure notes.	Intra-operative
Number of Steroid Injections	The number of steroid injections per participant administered to the index shoulder over 12 months post-index surgery as reported in the participant diary and/or in the participant's medical record.	Following index surgery, up to 12 months
Number of Unscheduled Clinic Visits	The number of unscheduled clinic visits per participant (defined as a return visit to a health care provider for examination/evaluation of the index shoulder) over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record.	Following index surgery, up to 12 months
Number of For-Cause Imaging Procedures	The total number of for cause imaging procedures (e.g., MRI or ultrasound) per participant performed on the index shoulder over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record	Following index surgery, up to 12 months
Number of Physiotherapy Sessions	The total number of physiotherapy sessions per participant over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record	Following index surgery, up to 12 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Collaborators: Medical Metrics Diagnostics, Inc; Global Research Solutions
• Investigators: Principal Investigator: Howard Harris, Texas Orthopedic Specialists

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): September 11, 2023
• Study Completion (Actual): September 11, 2023

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: rotator cuff tear; rotator cuff repair; REGENETEN; REGENETEN Bioinductive Implant; highgrade partial thickness tear
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: REGEN.PUB.2018.09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes