Rotator Cuff Injury to Surgery (RC-IS)
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|ClinicalTrials.gov Identifier: NCT01744080|
Recruitment Status : Withdrawn (Logistic issues could not be resolved - study closed without any patients recruited)
First Posted : December 6, 2012
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Other: Regular Wait Time Other: Early Surgery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Surgical Wait Times on Outcomes of Rotator Cuff Surgery|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2018|
|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.
- Western Ontario Rotator Cuff [ Time Frame: 24 months ]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 ]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 ]Time will be calculated from initial injury to consultation to surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744080
|Pan Am Clinic|
|Winnipeg, Manitoba, Canada, R3M3E4|
|Principal Investigator:||Jeff Leiter, MSc, PhD||Pan Am Clinic|