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Completed

NCT Number: NCT01987973

Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

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.

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Key information

Conditions

Rotator Cuff Syndrome Disorder of Rotator Cuff Full Thickness Rotator Cuff Tear Rotator Cuff Injuries Rotator Cuff Injury Rupture Shoulder Injuries Skin Graft (Allograft) (Autograft) Failure Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H2E1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non surgical candidate, unable to consent

Treatment and study plan

Partial Rotator Cuff Repair

Procedure

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

Partial Rotator Cuff Repair with Allograft Augmentation

Procedure

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

Primary outcomes

  1. Western Ontario Rotator Cuff (WORC) Index

    Time frame: 24 months

    A patient questionnaire evaluating shoulder pain, function.

Sponsors and collaborators

Lead sponsor

Ivan Wong

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Nov 20, 2013
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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