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Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987973
Recruitment Status : Active, not recruiting
First Posted : November 20, 2013
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Ivan Wong, Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE November 9, 2013
First Posted Date  ICMJE November 20, 2013
Last Update Posted Date July 24, 2019
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Western Ontario Rotator Cuff (WORC) Index [ Time Frame: 24 months ]
A patient questionnaire evaluating shoulder pain, function.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone
Official Title  ICMJE Arthroscopic Repair of Chronic Two-tendon Rotator Cuff Tears by Human Dermal Allograft
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rotator Cuff Syndrome
  • Rotator Cuff Injury
  • Disorder of Rotator Cuff
  • Full Thickness Rotator Cuff Tear
  • Skin Graft (Allograft) (Autograft) Failure
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Partial Rotator Cuff Repair
  • Experimental: Allograft Reconstruction
    Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair with Allograft Augmentation"
    Intervention: Procedure: Partial Rotator Cuff Repair with Allograft Augmentation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 23, 2019)
29
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)
30
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Non surgical candidate, unable to consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01987973
Other Study ID Numbers  ICMJE 2014-182
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ivan Wong, Nova Scotia Health Authority
Study Sponsor  ICMJE Ivan Wong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ivan H Wong, MD FRCS(C) Nova Scotia Health Authority
PRS Account Nova Scotia Health Authority
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP