Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

Rotator Cuff Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987973
• Other study ID #: 2014-182
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: March 2021

Study information

• Verified date: March 2022
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non surgical candidate, unable to consent

Related Conditions & MeSH terms

• Disorder of Rotator Cuff
• Full Thickness Rotator Cuff Tear
• Rotator Cuff Injuries
• Rotator Cuff Injury
• Rotator Cuff Syndrome
• Skin Graft (Allograft) (Autograft) Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Ivan Wong

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario Rotator Cuff (WORC) Index	A patient questionnaire evaluating shoulder pain, function.	24 months