Clinical trial NCT01744080: Rotator Cuff Injury to Surgery
Official title: Effect of Surgical Wait Times on Outcomes of Rotator Cuff Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Rotator cuff
Lead sponsor: Panam Clinic
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 45 and 70 years old
* Acute full-thickness rotator cuff tear of supraspinatus an/or infraspinatus (as confirmed by appropriate diagnostic imagine)

Exclusion Criteria:

* Presence of a tear of the subscapularis and/or teres minor;
* Presence of a partial-thickness tear of the supraspinatus/infraspinatus;
* Patient has undergone previous RC surgery to the affected shoulder;
* Patient has an active WCB Claim or prior claim related to their shoulder;
* Previous major joint trauma, infection, or avascular necrosis;
* Chronic dislocation, inflammation, or degenerative glenohumeral arthropathy;
* Evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
* Psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
* Major medical illness where life expectancy is less than 2 years;
* Does not speak/read/understand English;
* No fixed address or means of contact;
* Unwillingness to complete necessary follow-ups

Primary outcomes:
measure: Western Ontario Rotator Cuff
timeFrame: 24 months
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES)
timeFrame: 24 months
Other outcomes:
measure: Injury to Surgery Time
timeFrame: 24 months
Locations:
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
Study officials:
affiliation: Pan Am Clinic
name: Jeff Leiter, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: