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Early Mobilization Following Arthroscopic Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
No Sling
Sling
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is over 18 years of age
  2. Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)
  3. Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)

Exclusion Criteria:

  1. Patient has a full-thickness tear of the subscapularis and/or teres minor
  2. Patient has undergone previous RC surgery to the affected shoulder
  3. Patient has major joint trauma, infection, or avascular necrosis
  4. Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
  5. Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
  6. Patient has a 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
  7. Patient has a major medical illness where life expectancy is less than 2 years
  8. Patient does not speak/read/understand English
  9. Patient has no fixed address or means of contact
  10. Surgeon or patient has decided to cancel surgery
  11. Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)
  12. Patient unwilling to complete necessary follow-ups

Sites / Locations

  • Glen Sather Sports Medicine clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (early ROM)

Group B (usual care)

Arm Description

Group A (early ROM) will use the sling for comfort only

Group B (usual care) will be immobilized in a sling for 6 weeks.

Outcomes

Primary Outcome Measures

Western Ontario Rotator Cuff Index (WORC)
a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best
Range of Motion (ROM)
Measured flexion, abduction, external rotation in 90 degrees abduction [ER(90)], internal rotation in 90 degrees abduction [IR(90)], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout

Secondary Outcome Measures

Strength
strength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT). Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion. External and internal rotation were measured in 90 degrees of abduction. Peak values were recorded during each contraction which was held for 3 seconds. Values were expressed as raw values.
The Short Form (36) Health Survey
The Short Form (36) Health Survey is a quality of life questionnaire that looks at eight scales: physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health. Each scale ranges between 0 (completely disable) to 100 (completely able).
Adverse Events
The following complications were monitored throughout study: Medical related: urinary, gastrointestinal, cardiac, pulmonary, metabolic Surgical related: nerve injury, superficial or deep infection, dislocation, frozen shoulder, hematoma, biceps rupture, failure of tendon healing, dermatitis, reflex sympathetic dystrophy (RSD), persistent pain, re-injury. Other The surgeon responsible for the patient used clinical judgment to make a decision regarding if the complication was related or not to the treatment being tested (use or not of sling).
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)

Full Information

First Posted
April 8, 2011
Last Updated
October 13, 2021
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01333527
Brief Title
Early Mobilization Following Arthroscopic Rotator Cuff Repair
Official Title
Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation. This study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups: Patients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only. Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery. Patients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (early ROM)
Arm Type
Experimental
Arm Description
Group A (early ROM) will use the sling for comfort only
Arm Title
Group B (usual care)
Arm Type
Active Comparator
Arm Description
Group B (usual care) will be immobilized in a sling for 6 weeks.
Intervention Type
Procedure
Intervention Name(s)
No Sling
Intervention Description
Early range of motion
Intervention Type
Procedure
Intervention Name(s)
Sling
Intervention Description
Patients will use the sling for 6 weeks, as per usual care
Primary Outcome Measure Information:
Title
Western Ontario Rotator Cuff Index (WORC)
Description
a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Range of Motion (ROM)
Description
Measured flexion, abduction, external rotation in 90 degrees abduction [ER(90)], internal rotation in 90 degrees abduction [IR(90)], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary Outcome Measure Information:
Title
Strength
Description
strength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT). Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion. External and internal rotation were measured in 90 degrees of abduction. Peak values were recorded during each contraction which was held for 3 seconds. Values were expressed as raw values.
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
The Short Form (36) Health Survey
Description
The Short Form (36) Health Survey is a quality of life questionnaire that looks at eight scales: physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health. Each scale ranges between 0 (completely disable) to 100 (completely able).
Time Frame
baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Adverse Events
Description
The following complications were monitored throughout study: Medical related: urinary, gastrointestinal, cardiac, pulmonary, metabolic Surgical related: nerve injury, superficial or deep infection, dislocation, frozen shoulder, hematoma, biceps rupture, failure of tendon healing, dermatitis, reflex sympathetic dystrophy (RSD), persistent pain, re-injury. Other The surgeon responsible for the patient used clinical judgment to make a decision regarding if the complication was related or not to the treatment being tested (use or not of sling).
Time Frame
2 weeks, 6 weeks, 3 months, 6months
Title
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Description
Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)
Time Frame
baseline, 6 weeks, 3, 6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is over 18 years of age Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises) Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound) Exclusion Criteria: Patient has a full-thickness tear of the subscapularis and/or teres minor Patient has undergone previous RC surgery to the affected shoulder Patient has major joint trauma, infection, or avascular necrosis Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging) Patient has a 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 Patient has a major medical illness where life expectancy is less than 2 years Patient does not speak/read/understand English Patient has no fixed address or means of contact Surgeon or patient has decided to cancel surgery Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology) Patient unwilling to complete necessary follow-ups
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Sheps, MD,MSc,FRCSC
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glen Sather Sports Medicine clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2H9
Country
Canada

12. IPD Sharing Statement

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Early Mobilization Following Arthroscopic Rotator Cuff Repair

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