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Rotator Cuff Injury to Surgery (RC-IS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (Logistic issues could not be resolved - study closed without any patients recruited)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
Information provided by (Responsible Party):
Peter MacDonald, Panam Clinic

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Other: Regular Wait Time Other: Early Surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. Injury to Surgery Time [ Time Frame: 24 months ]
    Time will be calculated from initial injury to consultation to surgery.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01744080

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Canada, Manitoba
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M3E4
Sponsors and Collaborators
Panam Clinic
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Principal Investigator: Jeff Leiter, MSc, PhD Pan Am Clinic
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Responsible Party: Peter MacDonald, Department Head, Orthopaedics, Panam Clinic Identifier: NCT01744080    
Other Study ID Numbers: B2012:112
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by Peter MacDonald, Panam Clinic:
Rotator cuff
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries