Post-Market Evaluation of the Rotation Medical Rotator Cuff System

The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the treatment of supraspinatus tendon tears.

Study Overview

• Status: Completed
• Conditions: Partial Thickness Supraspinatus Tendon Tear; Full Thickness Supraspinatus Tendon Tear
• Intervention / Treatment: Device: Bioinductive implant; Device: Surgical repair

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Van Nuys, California, United States, 91405
      • Southern California Orthopedic Institute
  • Colorado
    • Denver, Colorado, United States, 80111
      • Steadman Hawkins Clinic-Denver
  • Florida
    • Fort Lauderdale, Florida, United States, 33334
      • Holy Cross Hospital Orthopedic Research Institute
  • Georgia
    • Rome, Georgia, United States, 30165
      • Harbin Clinic Orthopaedics & Sports Medicine Rome
  • Illinois
    • Rockford, Illinois, United States, 61107
      • OrthoIllinois, LTD
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Sports Medicine
  • Maryland
    • Towson, Maryland, United States, 21204
      • Towson Orthopaedic Associates / University of Maryland St Joseph Med Ctr
  • Michigan
    • Traverse City, Michigan, United States, 49684
      • Great Lakes Orthopaedic Center
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Twin Cities Orthopedics
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Orthopaedic Associates, P.A.
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute
  • Ohio
    • Cleveland, Ohio, United States, 44125
      • Cleveland Clinic
  • Texas
    • Bedford, Texas, United States, 76021
      • Texas Orthopedic Specialists, P.L.L.C.
    • Houston, Texas, United States, 77030
      • Bone & Joint Clinic Of Houston
  • Washington
    • Kirkland, Washington, United States, 98034
      • ProOrtho Orthopedic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

Subjects enrolled in the study MUST meet all of the following criteria:

1. At least 21 years of age

2. Rotator cuff tear requiring surgery that meets either criterion A or B:

   A. Medium or large partial-thickness tear or very small full-thickness tear of the supraspinatus tendon planned for standalone treatment (no surgical repair with sutures/suture anchors) with the bioinductive implant B. Medium or large full-thickness tear primarily of the supraspinatus tendon planned for treatment with the bioinductive implant adjunctive to surgical repair

3. Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections
4. MRI of the shoulder within 60 days prior to the study procedure
5. Willing to comply with the prescribed post-operative rehabilitation program
6. Willing to be available for each protocol-required follow-up examination
7. Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures
8. Ability to read, understand, and complete subject-reported outcomes in English

EXCLUSION CRITERIA

Subjects enrolled in the study MUST NOT meet any of the following criteria:

1. Massive rotator cuff tears (≥ 5 cm)
2. Acute rotator cuff tears less than 12 months from injury
3. Previous rotator cuff surgery on the index shoulder
4. Instability of the index shoulder
5. Chondromalacia of index shoulder ≥ Grade 3
6. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2
7. Calcification of the index shoulder rotator cuff
8. Genetic collagen disease
9. History of insulin dependent diabetes
10. History of auto-immune or immunodeficiency disorders
11. History of chronic inflammatory disorders
12. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
13. History of heavy smoking (> 1 pack per day) within last 6 months
14. Hypersensitivity to bovine-derived materials
15. Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
16. Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder
17. Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
18. History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
19. History of cognitive or mental health status that interferes with study participation

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
Experimental: Partial-Thickness Tear; Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Device: Bioinductive implant; Other Names: Rotation Medical Rotator Cuff System™; REGENETEN™ Bioinductive Implant System.
Experimental: Full Thickness Tear; Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.	Device: Bioinductive implant; Other Names: Rotation Medical Rotator Cuff System™; REGENETEN™ Bioinductive Implant System.; Device: Surgical repair; Surgical repair with commercially-available sutures/suture anchors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tendon Thickness	The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).	Pre-operatively (baseline) to 3 month, 1 year, and 2 year
Integration of Induced Tissue With Underlying Tendon	Partial-thickness tears were classified as Intermediate (3-6 mm) or High (> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions: Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?; Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?; Was there evidence of bursitis in the shoulder?; Does the new tissue resemble normal tendon tissue?; Does the underlying tendon resemble normal tendon tissue?; Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?	3 months, 1 year, and 2 years
Fill-In of Partial Thickness Tears and Underlying Tendon Quality	For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as: 0 to <25%; 25% to <50%; 50% to < 75%; 75% to < 100%; 100%	3 months, 1 year, and 2 years
Number of Participants With a Re-Tear	Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.	3 months, 1 year, and 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Parameters: Device Implant Time	Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.	Intraoperative
Procedure Parameters: Procedure Technical Success	Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).	Intraoperative
American Shoulder and Elbow Society (ASES) Score	The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows: ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better).; ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better).; ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better). Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).	Baseline, 3 month, 1 year, and 2 years
Constant-Murley Shoulder (CMS) Score	The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).	Baseline, 3 months, 1 year, and 2 years
Recovery: Sling Time	Cumulative number of days index shoulder was in a sling.	Post-operatively to study completion, approximately 2 years
Recovery: Rehabilitation Time	Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.	Post-operatively to study completion, approximately 2 years
Recovery: Return to Work	Cumulative number of days between discharge and return to work (employed subjects only).	Post-operatively to study completion, approximately 2 years
Recovery: Return to Normal Daily Activities	Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.	Post-operatively to study completion, approximately 2 years
Participant Satisfaction	Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following: Strongly Disagree; Disagree; Neither Agree or Disagree; Agree; Strongly Agree "Strongly Disagree" indicated the lowest level of satisfaction and "Strongly Agree" indicated the greatest level of satisfaction.	3 months, 1 year, and 2 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Laura England, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2014
• Primary Completion (Actual): November 24, 2020
• Study Completion (Actual): November 24, 2020

Study Registration Dates

• First Submitted: July 23, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2014.05.12

Drug and device information, study documents

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