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Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Ivan Wong, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01987973
First received: November 9, 2013
Last updated: July 22, 2014
Last verified: July 2014
  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 Alone
Procedure: Allograft Augmentation of Partial Rotator Cuff Repair

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 Capital District Health Authority, Canada:

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 Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Partial Rotator Cuff Repair Alone
This is the control group.
Procedure: Partial Rotator Cuff Repair Alone
This is the control group.
Experimental: Allograft reconstruction
allograft reconstruction after partial repair
Procedure: Allograft Augmentation of Partial Rotator Cuff Repair
Following initial partial rotator cuff repair, patients in this arm will undergo a second procedure at six week consisting of allograft augmentation of the initial repair.
Other Name: Human dermal allograft

  Eligibility

Ages Eligible for Study:   18 Years and older
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ivan Wong, Orthopedic Surgeon, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01987973     History of Changes
Other Study ID Numbers: 2014-182
Study First Received: November 9, 2013
Last Updated: July 22, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 26, 2014