Clinical trial NCT01706978: A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair
Official title: A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair: Soft Tissue or Bone Trephination, a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: rotator cuff tear
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Ottawa
First posted: 2012-10-15
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

1. 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.
2. Partial thickness cuff tears.
3. Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis
4. Previous surgery on affected shoulder e.g. Previous rotator cuff repair.
5. Patients with active worker's compensation claims
6. Active joint or systemic infection
7. Significant muscle paralysis
8. Rotator cuff tear arthropathy
9. Charcot's arthropathy
10. Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)
11. Major medical illness (life expectancy less then 1 year or unacceptably high operative risk)
12. Unable to speak or read English/French
13. Psychiatric illness that precludes informed consent
14. Unwilling to be followed for 1 year
15. Advanced physiologic age

Primary outcomes:
measure: Western Ontario Rotator Cuff Index
timeFrame: From baseline to up until 24-Months Post-Operative
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores
timeFrame: From baseline to up until 24-Months Post-Operative
measure: The Constant Score
timeFrame: From baseline to up until 24-Months Post-Operative
measure: Healing Rates
timeFrame: From surgery to up until 24-Months Post-Operative
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Peter Lapner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Guy Trudel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.