Post-Market Evaluation of the Rotation Medical Rotator Cuff System

Smith & Nephew

Status: Completed

Conditions: Partial Thickness Supraspinatus Tendon Tear; Full Thickness Supraspinatus Tendon Tear

Treatments: Device: Bioinductive implant; Device: Surgical repair

Study type: Interventional

Funder types: Industry

Identifiers

NCT02200939

2014.05.12

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Partial-Thickness Tear

Experimental group

Description:

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.

Treatment:

Device: Bioinductive implant

Full Thickness Tear

Experimental group

Description:

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

Treatment:

Device: Surgical repair

Device: Bioinductive implant