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Rotator Cuff Injury to Surgery (RC-IS)

Primary Purpose

Rotator Cuff Tear

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Regular Wait Time
Early Surgery
Sponsored by
Panam Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator cuff

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pan Am Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Early Surgery

Regular Wait Time

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2012
Last Updated
April 3, 2017
Sponsor
Panam Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01744080
Brief Title
Rotator Cuff Injury to Surgery
Acronym
RC-IS
Official Title
Effect of Surgical Wait Times on Outcomes of Rotator Cuff Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Logistic issues could not be resolved - study closed without any patients recruited
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panam Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Rotator cuff

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Surgery
Arm Type
Active Comparator
Arm Title
Regular Wait Time
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Regular Wait Time
Intervention Description
Surgery will take place no earlier than 9 months and no later than 12 months after the sport medicine physician consult.
Intervention Type
Other
Intervention Name(s)
Early Surgery
Intervention Description
Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.
Primary Outcome Measure Information:
Title
Western Ontario Rotator Cuff
Description
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
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons (ASES)
Description
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
Other Pre-specified Outcome Measures:
Title
Injury to Surgery Time
Description
Time will be calculated from initial injury to consultation to surgery.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Leiter, MSc, PhD
Organizational Affiliation
Pan Am Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pan Am Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M3E4
Country
Canada

12. IPD Sharing Statement

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Rotator Cuff Injury to Surgery

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