Rotator Cuff Injury to Surgery

NCT ID: NCT01744080

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Rotator Cuff Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Surgery

Group Type: ACTIVE_COMPARATOR

Early Surgery

Intervention Type: OTHER

Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.

Regular Wait Time

Group Type: EXPERIMENTAL

Regular Wait Time

Intervention Type: OTHER

Surgery will take place no earlier than 9 months and no later than 12 months after the sport medicine physician consult.

Interventions

Regular Wait Time

Surgery will take place no earlier than 9 months and no later than 12 months after the sport medicine physician consult.

Intervention Type: OTHER

Early Surgery

Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Panam Clinic

OTHER

Sponsor Role: lead

Responsible Party

Peter MacDonald

Department Head, Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeff Leiter, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Pan Am Clinic

Locations

Pan Am Clinic

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2012:112

Identifier Type: -

Identifier Source: org_study_id