Post-Market Evaluation of the Rotation Medical Rotator Cuff System

NCT02200939 | Completed Results FDA Device

• 1 other identifier: 2014.05.12
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 15

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

Outcome Measures

Primary Outcomes (4)

• 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: 1. Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? 2. Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? 3. Was there evidence of bursitis in the shoulder? 4. Does the new tissue resemble normal tendon tissue? 5. Does the underlying tendon resemble normal tendon tissue? 6. 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 Outcomes (9)

• Procedure Parameters: Device Implant Time

  Intraoperative

• Procedure Parameters: Procedure Technical Success

  Intraoperative

• American Shoulder and Elbow Society (ASES) Score

  Baseline, 3 month, 1 year, and 2 years

• Constant-Murley Shoulder (CMS) Score

  Baseline, 3 months, 1 year, and 2 years

• Recovery: Sling Time

  Post-operatively to study completion, approximately 2 years

Study Arms (2)

Partial-Thickness Tear

EXPERIMENTAL

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

Full Thickness Tear

EXPERIMENTAL

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

Device: Bioinductive implant; Device: Surgical repair

Interventions

Bioinductive implant DEVICE

Also known as: Rotation Medical Rotator Cuff System™, REGENETEN™ Bioinductive Implant System.

Full Thickness Tear; Partial-Thickness Tear

Surgical repair DEVICE

Surgical repair with commercially-available sutures/suture anchors.

Full Thickness Tear

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects enrolled in the study MUST meet all of the following criteria:
• At least 21 years of age
• 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
• Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections
• MRI of the shoulder within 60 days prior to the study procedure
• Willing to comply with the prescribed post-operative rehabilitation program
• Willing to be available for each protocol-required follow-up examination
• 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
• Ability to read, understand, and complete subject-reported outcomes in English

You may not qualify if:

• Subjects enrolled in the study MUST NOT meet any of the following criteria:
• Massive rotator cuff tears (≥ 5 cm)
• Acute rotator cuff tears less than 12 months from injury
• Previous rotator cuff surgery on the index shoulder
• Instability of the index shoulder
• Chondromalacia of index shoulder ≥ Grade 3
• Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2
• Calcification of the index shoulder rotator cuff
• Genetic collagen disease
• History of insulin dependent diabetes
• History of auto-immune or immunodeficiency disorders
• History of chronic inflammatory disorders
• Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
• History of heavy smoking (\> 1 pack per day) within last 6 months
• Hypersensitivity to bovine-derived materials

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (15)

Southern California Orthopedic Institute

Van Nuys, California, 91405, United States

Location

Steadman Hawkins Clinic-Denver

Denver, Colorado, 80111, United States

Location

Holy Cross Hospital Orthopedic Research Institute

Fort Lauderdale, Florida, 33334, United States

Location

Harbin Clinic Orthopaedics & Sports Medicine Rome

Rome, Georgia, 30165, United States

Location

OrthoIllinois, LTD

Rockford, Illinois, 61107, United States

Location

University of Iowa Sports Medicine

Iowa City, Iowa, 52242, United States

Location

Towson Orthopaedic Associates / University of Maryland St Joseph Med Ctr

Towson, Maryland, 21204, United States

Location

Great Lakes Orthopaedic Center

Traverse City, Michigan, 49684, United States

Location

Twin Cities Orthopedics

Edina, Minnesota, 55435, United States

Location

Princeton Orthopaedic Associates, P.A.

Princeton, New Jersey, 08540, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44125, United States

Location

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

Bedford, Texas, 76021, United States

Location

Bone & Joint Clinic of Houston

Houston, Texas, 77030, United States

Location

ProOrtho Orthopedic Clinic

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Interventions

Sutureless Surgical Procedures

Intervention Hierarchy (Ancestors)

Wound Closure Techniques; Surgical Procedures, Operative

Limitations and Caveats

Limitations of the study include minimal source data verification, limited safety event collection due to protocol definition, the independent Sponsor safety review occurred after data was locked and extracted from the database due to acquisition integration process.

Results Point of Contact

• Title: Laura England, Sr. Director Global Clinical Strategy
• Organization: Smith+Nephew, Inc.

Laura.England@smith-nephew.com

+1 650 223 6941

Study Officials

• Laura England

  Smith & Nephew, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: August 20, 2014
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-02

Locations

US (15)