A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair
1 other identifier
interventional
176
1 country
1
Brief Summary
This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff repair; soft tissue and bone trephination. "Trephination" is a procedure that involves making small perforations either in the torn tendon near its edge, or in the bone that the tendon is repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon. This study will help to determine whether this technique improves the speed of healing, the strength and the re-tear rate of the repair. You are being asked to take part in this study because you have a tear of the rotator cuff that requires surgical treatment. A total of 90 participants will participate in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 24, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedResults Posted
Study results publicly available
May 6, 2020
CompletedSeptember 18, 2020
September 1, 2020
6.4 years
July 24, 2012
March 25, 2020
September 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Western Ontario Rotator Cuff Index
The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.
From baseline to up until 24-Months Post-Operative
Secondary Outcomes (3)
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores
From baseline to up until 24-Months Post-Operative
The Constant Score
From baseline to up until 24-Months Post-Operative
Healing Rates
From surgery to up until 24-Months Post-Operative
Study Arms (2)
Soft Tissue Trephination
EXPERIMENTALTen days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.
Bone Trephination
ACTIVE COMPARATORTen days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.
Interventions
Eligibility Criteria
You may qualify if:
- Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
- Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months.
- Medical management will be defined as:
- The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
- Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc)
- Activity modification
- Imaging, and intra-operative findings confirming a full thickness tear of the rotator cuff.
You may not qualify if:
- Characteristics of the cuff tear that render the cuff irrepairable: fatty infiltration in the muscles grade III (50%) or greater; superior subluxation of the humeral head; retraction of the cuff to the level of the glenoid rim.
- Partial thickness cuff tears.
- Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis
- Previous surgery on affected shoulder e.g. Previous rotator cuff repair.
- Patients with active worker's compensation claims
- Active joint or systemic infection
- Significant muscle paralysis
- Rotator cuff tear arthropathy
- Charcot's arthropathy
- Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)
- Major medical illness (life expectancy less then 1 year or unacceptably high operative risk)
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for 1 year
- Advanced physiologic age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- University of Ottawacollaborator
Study Sites (1)
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Related Publications (1)
Campbell TM, Lapner P, Dilworth FJ, Sheikh MA, Laneuville O, Uhthoff H, Trudel G. Tendon contains more stem cells than bone at the rotator cuff repair site. J Shoulder Elbow Surg. 2019 Sep;28(9):1779-1787. doi: 10.1016/j.jse.2019.02.008. Epub 2019 Apr 26.
PMID: 31036422RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The sample size achieved would have detected a clinically significant difference based on power analysis but remains susceptible to type II error. The lack of a prospective control group also restricts the interpretation of the study finding.
Results Point of Contact
- Title
- Dr. Peter Lapner
- Organization
- The Ottawa Hospital Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Lapner, MD
The Ottawa Hospital
- PRINCIPAL INVESTIGATOR
Guy Trudel, MD
University of Ottawa
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2012
First Posted
October 15, 2012
Study Start
April 1, 2012
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
September 18, 2020
Results First Posted
May 6, 2020
Record last verified: 2020-09