Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

Arthroscopic Repair of Chronic Two-tendon Rotator Cuff Tears by Human Dermal Allograft

The investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injury; Full Thickness Rotator Cuff Tear; Rotator Cuff Syndrome; Disorder of Rotator Cuff; Skin Graft (Allograft) (Autograft) Failure
• Intervention / Treatment: Procedure: Partial Rotator Cuff Repair; Procedure: Partial Rotator Cuff Repair with Allograft Augmentation

Detailed Description

A total of 30 patients will be enrolled in the study. Subjects will be randomized into two arms, either (1) Partial Repair/Debridement or (2) Allograft Reconstruction.

The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant, Pre-operatively and Post-operatively at 6 weeks, 3, 6, 12, 24 months. The examination will consist of range of motion testing by goniometer as well as strength testing by hand dynamometer. The patient will also complete the Western Ontario Rotator Cuff Index (WORC) questionnaire.

The main benefit of this procedure is that patients who have currently irreparable massive, chronic rotator cuff tears may acquire a means for their cuff to be repaired. This may aid in improving function of the shoulder, restoring ability to complete activities of daily living, while decreasing pain and sleep disturbances. This would allow the participant to become more functional after rehabilitation. It is our belief that this study could provide new information in helping to understand this relationship, which would in turn lead to future study in this area of orthopaedic surgery.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H2E1
      • Nova Scotia Health Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Large/Massive rotator cuff tear >3cm proven on MRI

Exclusion Criteria:

• Non surgical candidate, unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Partial Repair / Debridement; Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair". This is the control group.	Procedure: Partial Rotator Cuff Repair; This is the control group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. If possible, rip-stop sutures will be employed to stabilize the tear. The subacromial space will then be thoroughly irrigated.; Other Names: Debridement
Experimental: Allograft Reconstruction; Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair with Allograft Augmentation"	Procedure: Partial Rotator Cuff Repair with Allograft Augmentation; Patients in this arm will undergo a partial rotator cuff repair (debridement), followed by an allograft augmentation. An Allopatch HD patch will be rehydrated in saline solution for 15 minutes. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed at least 3 cm medial to the tendon-bone attachment site. The patch is stretched to remove the manufacturing surface irregularities. The patch is then attached to the greater tuberosity at the tendon-bone attachment site with arthroscopic bone anchors. The subacromial space will then be thoroughly irrigated.; Other Names: Human dermal allograft; Allograft Reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Rotator Cuff (WORC) Index	A patient questionnaire evaluating shoulder pain, function.	24 months

Collaborators and Investigators

• Sponsor: Ivan Wong
• Investigators: Principal Investigator: Ivan H Wong, MD FRCS(C), Nova Scotia Health Authority

Publications and helpful links

General Publications

• Wong I, Sparavalo S, King JP, Coady CM. Bridging Allograft Reconstruction Is Superior to Maximal Repair for the Treatment of Chronic, Massive Rotator Cuff Tears: Results of a Prospective, Randomized Controlled Trial. Am J Sports Med. 2021 Oct;49(12):3173-3183. doi: 10.1177/03635465211039846. Epub 2021 Sep 8.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: November 9, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimate): November 20, 2013

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2014-182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO