Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone
NCT ID: NCT01987973
Last Updated: 2022-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2015-02-28
2021-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Partial Repair / Debridement
Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair". This is the control group.
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.
Allograft Reconstruction
Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair with Allograft Augmentation"
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ivan Wong
OTHER
Responsible Party
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Ivan Wong
Orthopedic Surgeon
Principal Investigators
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Ivan H Wong, MD FRCS(C)
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health Authority
Locations
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Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Countries
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References
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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.
Other Identifiers
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2014-182
Identifier Type: -
Identifier Source: org_study_id
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