Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Nova Scotia Health Authority
Sponsor:
Information provided by (Responsible Party):
Ivan Wong, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT01987973
First received: November 9, 2013
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arthroscopic Repair of Chronic Two-tendon Rotator Cuff Tears by Human Dermal Allograft

Resource links provided by NLM:


Further study details as provided by Nova Scotia Health Authority:

Primary Outcome Measures:
  • Western Ontario Rotator Cuff (WORC) Index [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    A patient questionnaire evaluating shoulder pain, function.


Estimated Enrollment: 30
Study Start Date: February 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Human dermal allograft
  • Allograft Reconstruction

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non surgical candidate, unable to consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987973

Contacts
Contact: Nicole Paquet, MSc CH&E 902-473-7626 nicole@drivanwong.com
Contact: Meaghan MacDonald 902-473-7626 meaghan@drivanwong.com

Locations
Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H2E1
Sponsors and Collaborators
Ivan Wong
Investigators
Principal Investigator: Ivan H Wong, MD FRCS(C) Nova Scotia Health Authority
  More Information

Responsible Party: Ivan Wong, Orthopedic Surgeon, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01987973     History of Changes
Other Study ID Numbers: 2014-182 
Study First Received: November 9, 2013
Last Updated: July 25, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on December 09, 2016