Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

NCT00957255 | Withdrawn

• 1 other identifier: O-0803
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tear

Keywords

rotator cuff tear; rotator cuff repair

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (2)

RCR without augmentation

ACTIVE COMPARATOR

Rotator cuff repair without OrthoADAPT augmentation

Procedure: Standard of care

RCR with augmentation

EXPERIMENTAL

Rotator cuff repair with OrthoADAPT augmentation

Device: OrthoADAPT

Interventions

OrthoADAPT DEVICE

soft tissue augmentation device

RCR with augmentation

Standard of care PROCEDURE

Standard of care rotator cuff repair

RCR without augmentation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Synovis Surgical Innovations: collaborator

Study Sites (1)

Seattle Medical Research Foundation

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

US (1)