Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

NACompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

December 31, 2019

Study Completion Date

March 31, 2021

Conditions
Rotator Cuff SyndromeRotator Cuff InjuryDisorder of Rotator CuffFull Thickness Rotator Cuff TearSkin Graft (Allograft) (Autograft) Failure
Interventions
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.

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.

Trial Locations (1)

B3H2E1

Nova Scotia Health Authority, Halifax

All Listed Sponsors
lead

Ivan Wong

OTHER

NCT01987973 - Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone | Biotech Hunter | Biotech Hunter