An interventional study of Regular Wait Time and Early Surgery in Rotator Cuff Tear, sponsored by Panam Clinic. Withdrawn at 1 site in Canada. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-04-05.
Sponsored by Panam Clinic · Not applicable, Interventional, and Treatment
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.
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.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
Browse Rotator Cuff Injuries studies →Panam Clinic is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Other: Early Surgery
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.
Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.
Western Ontario Rotator Cuff
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
Time frame: 24 months
American Shoulder and Elbow Surgeons (ASES)
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
Time frame: 24 months
Injury to Surgery Time
Time will be calculated from initial injury to consultation to surgery.
Time frame: 24 months
This study is withdrawn, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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