Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups. Each group is then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.

Study Overview

• Status: Withdrawn
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: Standard of care; Device: OrthoADAPT

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle Medical Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 18-70
• MRI confirmed full thickness or high grade partial thickness rotator cuff tear equal or more than 1 cm and involving the supraspinatus and/or infraspinatus tendons
• Tear is repairable by surgery using protocol prescribed fixation procedure
• Patient is able to sign and IRB approved study informed consent
• Patient is willing and able to return for follow-up appointments and study related procedures
• Patient is willing to comply with prescribed physical therapy regimen

Exclusion Criteria:

• Emergency, poly trauma patients
• Prior same shoulder surgery including rotator cuff repair except prior subacromial decompression or distal clavicle resection
• Shoulder pathology requiring concomitant procedures during the rotator cuff repair including Labral repair, anterior or posterior stabilization, and/or capsular plication or shift
• Cervical spine disease
• History of adhesive capsulitis in either shoulder
• Patient whose injury does or may involve litigation
• Diabetics
• Rotator cuff tear cannot be repaired by primary surgical means including superiorly migrated humeral head, retracted rotator cuff that cannot be mobilized to humeral head, end stage tears, rotator cuff tissue cannot retain sutures, any comorbidities that would directly or indirectly affect the reparability of the cuff
• Patients with grade 3 or 4 glenohumeral arthritis
• Patients with systemic collage disease
• Patients with a known hypersensitivity to equine derived materials
• Active or latent infection
• Chronic use of immunosuppressive agents
• Any oral or IM NSAID usage within 5 days before surgery
• Cancer patients
• Decisional impaired patients
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: RCR without augmentation; Rotator cuff repair without OrthoADAPT augmentation	Procedure: Standard of care; Standard of care rotator cuff repair
EXPERIMENTAL: RCR with augmentation; Rotator cuff repair with OrthoADAPT augmentation	Device: OrthoADAPT; soft tissue augmentation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Passive and active range of motion	Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
American Shoulder and Elbow Surgeons assessment score	Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Constant shoulder score	Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Pain	Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
MRI	12 months
Rotator cuff re-rupture and adhesions	6 weeks, 3, 4, 6, 12 and 24 months
Incidence of device or procedure related adverse events	6 weeks, 3, 4, 6, 12, and 24 months

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Synovis Surgical Innovations
• Investigators: Principal Investigator: Charles DePaolo, MD, Mission Health Research Institute; Principal Investigator: Pierce Scranton, MD, Seattle Medical Research Foundation; Principal Investigator: William Bryan, MD, Methodist Center For Orthopedic Surgery

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): April 1, 2010
• Study Completion (ACTUAL): April 1, 2010

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 11, 2009
• First Posted (ESTIMATE): August 12, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: rotator cuff tear; rotator cuff repair
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: O-0803