Clinical trial NCT02200939: Post-Market Evaluation of the Rotation Medical Rotator Cuff System
Official title: Post-Market Evaluation of the Rotation Medical Rotator Cuff System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Thickness Supraspinatus Tendon Tear
Full Thickness Supraspinatus Tendon Tear
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 148
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Tendon Thickness
timeFrame: Pre-operatively (baseline) to 3 month, 1 year, and 2 year
measure: Integration of Induced Tissue With Underlying Tendon
timeFrame: 3 months, 1 year, and 2 years
measure: Fill-In of Partial Thickness Tears and Underlying Tendon Quality
timeFrame: 3 months, 1 year, and 2 years
measure: Number of Participants With a Re-Tear
timeFrame: 3 months, 1 year, and 2 years
Secondary outcomes:
measure: Procedure Parameters: Device Implant Time
timeFrame: Intraoperative
measure: Procedure Parameters: Procedure Technical Success
timeFrame: Intraoperative
measure: American Shoulder and Elbow Society (ASES) Score
timeFrame: Baseline, 3 month, 1 year, and 2 years
measure: Constant-Murley Shoulder (CMS) Score
timeFrame: Baseline, 3 months, 1 year, and 2 years
measure: Recovery: Sling Time
timeFrame: Post-operatively to study completion, approximately 2 years
measure: Recovery: Rehabilitation Time
timeFrame: Post-operatively to study completion, approximately 2 years
measure: Recovery: Return to Work
timeFrame: Post-operatively to study completion, approximately 2 years
measure: Recovery: Return to Normal Daily Activities
timeFrame: Post-operatively to study completion, approximately 2 years
measure: Participant Satisfaction
timeFrame: 3 months, 1 year, and 2 years
Other outcomes:
Locations:
city: Van Nuys
country: United States
facility: Southern California Orthopedic Institute
state: California
city: Denver
country: United States
facility: Steadman Hawkins Clinic-Denver
state: Colorado
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Orthopedic Research Institute
state: Florida
city: Rome
country: United States
facility: Harbin Clinic Orthopaedics & Sports Medicine Rome
state: Georgia
city: Rockford
country: United States
facility: OrthoIllinois, LTD
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Sports Medicine
state: Iowa
city: Towson
country: United States
facility: Towson Orthopaedic Associates / University of Maryland St Joseph Med Ctr
state: Maryland
city: Traverse City
country: United States
facility: Great Lakes Orthopaedic Center
state: Michigan
city: Edina
country: United States
facility: Twin Cities Orthopedics
state: Minnesota
city: Princeton
country: United States
facility: Princeton Orthopaedic Associates, P.A.
state: New Jersey
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Bedford
country: United States
facility: Texas Orthopedic Specialists, P.L.L.C.
state: Texas
city: Houston
country: United States
facility: Bone & Joint Clinic of Houston
state: Texas
city: Kirkland
country: United States
facility: ProOrtho Orthopedic Clinic
state: Washington
Study officials:
affiliation: Smith & Nephew, Inc.
name: Laura England
role: STUDY_CHAIR
References: