Back to resultsSubacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis
Primary Purpose
Tendinosis, Shoulder Impingement Syndrome
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Shoulder bursectomy alone
Sponsored by
About this trial
This is an interventional treatment trial for Tendinosis focused on measuring Rotator Cuff, Tendinosis, Impingement Syndrome, Partial Thickness Tears, Rotator Cuff Tendinosis, Partial Thickness Rotator Cuff Tears
Eligibility Criteria
Inclusion Criteria: Diagnosis of stage II rotator cuff impingement syndrome defined as: Pain referred to the anterior, lateral, or superior shoulder Pain exacerbated by overhead and reaching activities Positive Neer and/or Hawkins impingement signs Failure of 6 months of conservative treatment. Failed conservative treatment will be defined as persistent pain and disability despite adequate non-operative management for 6 months. Non-operative management will be defined as: Modification of activities The use of analgesic and/or anti-inflammatory medication Physiotherapy: Physiotherapy must have included the goal of regaining full range of motion, working towards normal kinematics through increased strength of the rotator cuff muscles. Patients should have obtained range of motion to 80% of the opposite shoulder (assuming this is normal) for each of: internal rotation, external rotation, and forward elevation. A physiotherapy program that involved massage, ultrasound, and/or heat only would not be considered adequate treatment for this study. Patients willing to be followed on a regular basis Patients 18 years of age and older Exclusion Criteria: Clinical evidence or history of major joint trauma, infection, surgery, glenohumeral arthritis, or instability. Clinical evidence of internal impingement. Patients with full-thickness rotator cuff tear as documented on advanced imaging or during surgery. Patients with bursal surface tears as documented on advanced imaging or during surgery. Patients who are found during surgery to have a partial-thickness tear greater than 50% of tendon thickness. Patients with evidence of a lateral down sloping acromion. Patients unfit for surgery Patients unable to provide informed consent or adequately participate in this study due to a language barrier or psychiatric illness. Patients with a major medical illness whose condition or treatment would affect their quality of life and, as such, affect the results of this study.
Sites / Locations
- University of Calgary Sport Medicine Centre
- Royal Columbian Hospital
- Pan Am Medical and Surgical Centre
- Fowler Kennedy Sport Medicine Clinic
- Hand and Upper Limb Clinic
- Orthopaedic and Arthritic Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Shoulder bursectomy and acromioplasty
Arm Description
Outcomes
Primary Outcome Measures
The Western Ontario Rotator Cuff (WORC) index
a disease specific quality of life measure for rotator cuff disease evaluated pre-operatively and at all post-operative visits
Secondary Outcome Measures
Full Information
NCT ID
NCT00196573
First Posted
September 12, 2005
Last Updated
April 24, 2014
Sponsor
University of Western Ontario, Canada
Collaborators
Fowler Kennedy Sport Medicine Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00196573
Brief Title
Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis
Official Title
A Randomized Clinical Trial Comparing the Effectiveness of Subacromial Decompression (Acromioplasty) Versus Subacromial Bursectomy (no Acromioplasty) in the Arthroscopic Treatment of Patients With Rotator Cuff Tendinosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Ontario, Canada
Collaborators
Fowler Kennedy Sport Medicine Clinic
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the effectiveness of arthroscopic subacromial decompression (acromioplasty) to arthroscopic subacromial bursectomy (no acromioplasty) in rotator cuff impingement syndrome. The investigators' hypothesis is that arthroscopic subacromial decompression provides no additional benefit, as evaluated with disease specific quality of life measures, compared to arthroscopic bursectomy.
Detailed Description
The most commonly performed surgical procedure to treat rotator cuff tendinosis, when no full-thickness tear exists, is subacromial decompression (acromioplasty). This procedure is based on the theory that primary acromial morphology, (an extrinsic cause), is the initiating factor leading to the dysfunction and eventual tearing of the rotator cuff.
Subacromial decompression involves surgical excision of the subacromial bursa, resection of the coracoacromial ligament, resection of the anteroinferior portion of the acromion, and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement.
Several studies have indicated that the vast majority of partial-thickness tears are found on the articular surface of the rotator cuff which is not in keeping with the theory that rotator cuff impingement is primarily a result of acromion morphology.
Burkhart proposed that pathologic changes in the supraspinatus tendon occur primarily as a result of overuse and tension overload (an intrinsic factor), resulting in superior migration of the humeral head during active elevation.
Budoff et al., suggest that since the coracoacromial ligament stabilizes the rotator cuff to prevent uncontrolled superior migration of the humeral head, resection of the coracoacromial ligament during arthroscopic subacromial decompression may cause, in the long-term, additional proximal migration of the humeral head.
Arthroscopic bursectomy with debridement of rotator cuff tears alone, without acromioplasty, addresses the primary anatomical pathology and may offer similar success rates to subacromial decompression, without the risk of future instability caused by resection of the acromion and coracoacromial ligament.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinosis, Shoulder Impingement Syndrome
Keywords
Rotator Cuff, Tendinosis, Impingement Syndrome, Partial Thickness Tears, Rotator Cuff Tendinosis, Partial Thickness Rotator Cuff Tears
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shoulder bursectomy and acromioplasty
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Shoulder bursectomy alone
Primary Outcome Measure Information:
Title
The Western Ontario Rotator Cuff (WORC) index
Description
a disease specific quality of life measure for rotator cuff disease evaluated pre-operatively and at all post-operative visits
Time Frame
Baseline, 2 & 6 weeks, 3, 6, 12, 18, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of stage II rotator cuff impingement syndrome defined as:
Pain referred to the anterior, lateral, or superior shoulder
Pain exacerbated by overhead and reaching activities
Positive Neer and/or Hawkins impingement signs
Failure of 6 months of conservative treatment. Failed conservative treatment will be defined as persistent pain and disability despite adequate non-operative management for 6 months. Non-operative management will be defined as:
Modification of activities
The use of analgesic and/or anti-inflammatory medication
Physiotherapy: Physiotherapy must have included the goal of regaining full range of motion, working towards normal kinematics through increased strength of the rotator cuff muscles. Patients should have obtained range of motion to 80% of the opposite shoulder (assuming this is normal) for each of: internal rotation, external rotation, and forward elevation. A physiotherapy program that involved massage, ultrasound, and/or heat only would not be considered adequate treatment for this study.
Patients willing to be followed on a regular basis
Patients 18 years of age and older
Exclusion Criteria:
Clinical evidence or history of major joint trauma, infection, surgery, glenohumeral arthritis, or instability.
Clinical evidence of internal impingement.
Patients with full-thickness rotator cuff tear as documented on advanced imaging or during surgery.
Patients with bursal surface tears as documented on advanced imaging or during surgery.
Patients who are found during surgery to have a partial-thickness tear greater than 50% of tendon thickness.
Patients with evidence of a lateral down sloping acromion.
Patients unfit for surgery
Patients unable to provide informed consent or adequately participate in this study due to a language barrier or psychiatric illness.
Patients with a major medical illness whose condition or treatment would affect their quality of life and, as such, affect the results of this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Willits, MD, FRCS(C)
Organizational Affiliation
Fowler Kennedy Sport Medicine Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary Sport Medicine Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 5P5
Country
Canada
Facility Name
Pan Am Medical and Surgical Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3E4
Country
Canada
Facility Name
Fowler Kennedy Sport Medicine Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Facility Name
Hand and Upper Limb Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Orthopaedic and Arthritic Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4Y 1H1
Country
Canada
12. IPD Sharing Statement
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Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis
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