Rotator Cuff Injury to Surgery (RC-IS)

This study is currently recruiting participants.
Verified March 2014 by Panam Clinic
Sponsor:
Information provided by (Responsible Party):
Peter MacDonald, Panam Clinic
ClinicalTrials.gov Identifier:
NCT01744080
First received: December 4, 2012
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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 Intervention
Rotator Cuff Tear
Other: Regular Wait Time
Other: Early Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Surgical Wait Times on Outcomes of Rotator Cuff Surgery

Further study details as provided by Panam Clinic:

Primary Outcome Measures:
  • Western Ontario Rotator Cuff [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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:
  • American Shoulder and Elbow Surgeons (ASES) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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:
  • Injury to Surgery Time [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Time will be calculated from initial injury to consultation to surgery.


Estimated Enrollment: 86
Study Start Date: January 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744080

Contacts
Contact: Jeff Leiter, MSc, PhD 204.927.2665 jleiter@panamclinic.com
Contact: Alexandra Legary, BSc 204.925.1558 alegary@panamclinic.com

Locations
Canada, Manitoba
Pan Am Clinic Recruiting
Winnipeg, Manitoba, Canada, R3M3E4
Contact: Jeff Leiter, MSc, PhD    204.927.2665    jleiter@panamclinic.com   
Contact: Alexandra Legary, BSc    204.925.1558    alegary@panamclinic.com   
Principal Investigator: Jeff Leiter, MSc, PhD         
Sub-Investigator: Sheila McRae, MSc, PhD(C)         
Sub-Investigator: Jason Old, MD, FRCSC         
Sub-Investigator: Greg Stranges, MD, FRCSC         
Sub-Investigator: Jamie Dubberley, MD, FRCSC         
Sub-Investigator: Peter MacDonald, MD, FRCSC         
Sponsors and Collaborators
Panam Clinic
Investigators
Principal Investigator: Jeff Leiter, MSc, PhD Pan Am Clinic
  More Information

No publications provided

Responsible Party: Peter MacDonald, Department Head, Orthopaedics, Panam Clinic
ClinicalTrials.gov Identifier: NCT01744080     History of Changes
Other Study ID Numbers: B2012:112
Study First Received: December 4, 2012
Last Updated: March 5, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Panam Clinic:
Rotator cuff

ClinicalTrials.gov processed this record on April 15, 2014