An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS

NCT00182299 | Unknown Phase 4 DMC

• 1 other identifier: 63140-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The prognosis for patients with large rotator cuff tears is poor. This recently developed biologic scaffold provides numerous structural and functional properties that may direct cell growth and aid in tendon healing. To date, there are no randomized clinical trials assessing the effectiveness of the patch to augment repairs of large rotator cuff tears. We propose a study to compare the rate of repair failure, quality of life, function, pain, and range of motion in 60 patients with large rotator cuff. Patients will be randomized (like flipping a coin) to undergo a standard rotator cuff repair with or without augmentation with SIS. Patients are assessed at 6 weeks, 3, 6, 12, 18, and 24 months post-operative

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• MRI defined failure of the cuff repair at 2 years postoperative

Secondary Outcomes (1)

• Quality of life (WORC, ASES), function (SST, CONSTANT), general health (SF-36), pain (VAS), analgesic use; forward flexion; internal/external rotation; lateral elevation

Interventions

porcine small intestine submucosa (SIS) PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Patients with large rotator cuff tears (Type 1B or Type 2) determined by clinical examination and diagnostic imaging. Criteria described by Harryman et al (1991) will guide the classification of rotator cuff tears defined and reassessed at the time of surgery (Type 0 = intact cuff, Type 1A = thinned cuff or partial thickness defect, Type 1B= full thickness defect on one tendon, Type 2 = full thickness defect of two tendons, Type 3 = full thickness defect of three tendons).

You may not qualify if:

• Previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy.
• Inability of the surgeon to repair the tear with remaining defect no greater than 10mm in diameter,
• Inability of the surgeon to repair the tear with less than 1cm of medialization,
• Evidence of other significant shoulder pathology including, Type II-IV SLAP lesion, Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis).
• Active joint or systemic infection,
• Significant muscle paralysis of the shoulder girdle,
• Major medical illness that would preclude undergoing surgery,
• Patients who are unwilling or unable to be assessed according to study protocol for one year following surgery
• Major psychiatric illness, developmental handicap or inability to read and understand the English language

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• DePuy Orthopaedics: collaborator
• London Health Sciences Centre: collaborator

Study Sites (1)

The University of Western Ontario

London, Ontario, N6G 1H1, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Dianne M Bryant, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2003
• Study Completion: April 1, 2008
• Last Updated: April 20, 2007

Record last verified: 2007-04

Locations

CA (1)