Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone
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|ClinicalTrials.gov Identifier: NCT01987973|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2013
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Syndrome Rotator Cuff Injury Disorder of Rotator Cuff Full Thickness Rotator Cuff Tear Skin Graft (Allograft) (Autograft) Failure||Procedure: Partial Rotator Cuff Repair Procedure: Partial Rotator Cuff Repair with Allograft Augmentation||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Arthroscopic Repair of Chronic Two-tendon Rotator Cuff Tears by Human Dermal Allograft|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2020|
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 Name: 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.
- Western Ontario Rotator Cuff (WORC) Index [ Time Frame: 24 months ]A patient questionnaire evaluating shoulder pain, function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987973
|Canada, Nova Scotia|
|Nova Scotia Health Authority|
|Halifax, Nova Scotia, Canada, B3H2E1|
|Principal Investigator:||Ivan H Wong, MD FRCS(C)||Nova Scotia Health Authority|