Post-Market Evaluation of the Rotation Medical Rotator Cuff System

NCT ID: NCT02200939

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-20
• Study Completion Date: 2020-11-24

Brief Summary

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.

Conditions

Partial Thickness Supraspinatus Tendon Tear; Full Thickness Supraspinatus Tendon Tear

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bioinductive implant

Intervention Type: DEVICE

Full Thickness Tear

Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.

Group Type: EXPERIMENTAL

Bioinductive implant

Intervention Type: DEVICE

Surgical repair

Intervention Type: DEVICE

Surgical repair with commercially-available sutures/suture anchors.

Interventions

Bioinductive implant

Intervention Type: DEVICE

Surgical repair

Surgical repair with commercially-available sutures/suture anchors.

Intervention Type: DEVICE

Other Intervention Names

Rotation Medical Rotator Cuff System™; REGENETEN™ Bioinductive Implant System.

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura England

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Locations

Southern California Orthopedic Institute

Van Nuys, California, United States

Steadman Hawkins Clinic-Denver

Denver, Colorado, United States

Holy Cross Hospital Orthopedic Research Institute

Fort Lauderdale, Florida, United States

Harbin Clinic Orthopaedics & Sports Medicine Rome

Rome, Georgia, United States

OrthoIllinois, LTD

Rockford, Illinois, United States

University of Iowa Sports Medicine

Iowa City, Iowa, United States

Towson Orthopaedic Associates / University of Maryland St Joseph Med Ctr

Towson, Maryland, United States

Great Lakes Orthopaedic Center

Traverse City, Michigan, United States

Twin Cities Orthopedics

Edina, Minnesota, United States

Princeton Orthopaedic Associates, P.A.

Princeton, New Jersey, United States

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Texas Orthopedic Specialists, P.L.L.C.

Bedford, Texas, United States

Bone & Joint Clinic of Houston

Houston, Texas, United States

ProOrtho Orthopedic Clinic

Kirkland, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014.05.12

Identifier Type: -

Identifier Source: org_study_id