Rotator Cuff Injury to Surgery (RC-IS)
The purpose of this prospective randomized controlled trial is to compare post-operative outcome between participants undergoing expedited surgery compared to those proceeding through a 'typical' wait time process. A secondary purpose is to evaluate the progression of rotator cuff tear size from the time of initial consult to the time of surgery.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Surgical Wait Times on Outcomes of Rotator Cuff Surgery|
- Western Ontario Rotator Cuff [ Time Frame: 24 months ] [ Designated as safety issue: No ]WORC score questionnaire is a tool designed for self-assessment of shoulder function for patients with rotator cuff problems. Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate
- American Shoulder and Elbow Surgeons (ASES) [ Time Frame: 24 months ] [ Designated as safety issue: No ]The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function. Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate
- Injury to Surgery Time [ Time Frame: 24 months ] [ Designated as safety issue: No ]Time will be calculated from initial injury to consultation to surgery.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
|Active Comparator: Early Surgery||
Other: Early Surgery
Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.
|Experimental: Regular Wait Time||
Other: Regular Wait Time
Surgery will take place no earlier than 9 months and no later than 12 months after the sport medicine physician consult.
Consented patients will undergo a pre-operative assessment conducted by a study physiotherapist, including the following: 1) demographic information (age, gender, height, weight, smoking status, employment, recreational activities, time of injury, etc.); 2) shoulder ROM, 3) shoulder strength using a handheld dynamometer, and 4) subjective shoulder-specific outcome measures which include the Western Ontario Rotator Cuff Score (WORC), American Shoulder and Elbow Score (ASES), and Simple Shoulder Test (SST). Measurement of tear size will also be documented by an experienced radiologist from the initial MRI or ultrasound.
Patients will undergo initial consultation with the orthopaedic surgeon to confirm suitability for surgical management. If deemed appropriate to continue as a participant, the individual participants will be randomized to one of the two study groups. If in the Expedited group, the patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sports medicine physician. If randomized to the Control or 'Typical Wait Time' Group, surgery will take place no earlier than 9 months and no later than 12 months after the sports medicine physician consult.
Just prior to surgery, a second diagnostic imaging test will take place, either ultrasound or MRI, to document progress in tear size and any secondary pathology in the control group. Diagnostic test findings will be confirmed intraoperatively. All rotator cuff repairs will be performed by one of four fellowship trained orthopaedic surgeons.
The control study group will be sent the subjective questionnaires at 8 week intervals while they are waiting for surgery. Post-surgery study follow-ups will take place at 6, 12, and 24 months for both groups. All patients will be provided with the same rehabilitation protocol including pain management, range of motion and strengthening exercises. The same data as that collected pre-surgery will be repeated as well as any occurrences of failure of the repair. Failure of the repair is defined as ongoing severe pain, limited ROM, and/or decreased strength. If a failure occurs, follow-ups will continue until 24 months following failure or 24 months following revision surgery, if performed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744080
|Contact: Jeff Leiter, MSc, PhDemail@example.com|
|Contact: Alexandra Legary, BScfirstname.lastname@example.org|
|Pan Am Clinic||Recruiting|
|Winnipeg, Manitoba, Canada, R3M3E4|
|Contact: Jeff Leiter, MSc, PhD 204.927.2665 email@example.com|
|Contact: Alexandra Legary, BSc 204.925.1558 firstname.lastname@example.org|
|Principal Investigator: Jeff Leiter, MSc, PhD|
|Sub-Investigator: Sheila McRae, MSc, PhD(C)|
|Sub-Investigator: Jason Old, MD, FRCSC|
|Sub-Investigator: Greg Stranges, MD, FRCSC|
|Sub-Investigator: Jamie Dubberley, MD, FRCSC|
|Sub-Investigator: Peter MacDonald, MD, FRCSC|
|Principal Investigator:||Jeff Leiter, MSc, PhD||Pan Am Clinic|