TendinosisPhase 3NCT00196573
Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis
A Phase 3 study testing Shoulder bursectomy alone in people with Tendinosis and Shoulder Impingement Syndrome, run by University of Western Ontario, Canada at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendinosis, Shoulder Impingement Syndrome
- What is being tested?
- Shoulder bursectomy alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 6 sitesCanada
- Study dates
- Nov 2003to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
University of Calgary Sport Medicine Centre
Calgary, Alberta, T2N 1N4
Fowler Kennedy Sport Medicine Clinic
London, Ontario, N6A 3K7
Hand and Upper Limb Clinic
London, Ontario, N6A 4L6
Royal Columbian Hospital
New Westminster, British Columbia, V3L 5P5
Orthopaedic and Arthritic Hospital
Toronto, Ontario, M4Y 1H1
Pan Am Medical and Surgical Centre
Winnipeg, Manitoba, R3M 3E4
About this study
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
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.
Read the 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.
- Conditions
- Tendinosis, Shoulder Impingement Syndrome
- Being tested
- Shoulder bursectomy alone
- Keywords
- Rotator Cuff, Tendinosis, Impingement Syndrome, Partial Thickness Tears, Rotator Cuff Tendinosis, Partial Thickness Rotator Cuff Tears
- Medical subject headings
- Tendinopathy, Shoulder Impingement Syndrome, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder bursectomy aloneProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Shoulder bursectomy and acromioplasty | Active comparator | Not described Receives: Procedure: Shoulder bursectomy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 2 & 6 weeks, 3, 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for TendinosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Fowler Kennedy Sport Medicine Clinic
- Responsible party
- Principal investigator, Dianne Bryant, University of Western Ontario, Canada
- Investigators
- Kevin Willits, MD, FRCS(C), Principal investigator, Fowler Kennedy Sport Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196573
- Sponsor's protocol ID
- FKSMC-AOSSM-1
- Other IDs
- WillitsYIG1
- Status last verified
- Apr 2014
- First submitted
- 12 Sep 2005
- Last updated
- 25 Apr 2014
- Results posted
- No
Publications
Altchek DW, Warren RF, Wickiewicz TL, Skyhar MJ, Ortiz G, Schwartz E. Arthroscopic acromioplasty. Technique and results. J Bone Joint Surg Am. 1990 Sep;72(8):1198-207.
PubMed 2398090Alvarez C, Kirkley A. The development of a disease specific quality of life measurement tool for rotator cuff disease. Presented at 23rd Clinical Seminar in Orthopaedic Surgery, London, Canada. May, 1995.
Andrews JR, Broussard TS, Carson WG. Arthroscopy of the shoulder in the management of partial tears of the rotator cuff: a preliminary report. Arthroscopy. 1985;1(2):117-22. doi: 10.1016/s0749-8063(85)80041-4.
PubMed 4091915Banas MP, Miller RJ, Totterman S. Relationship between the lateral acromion angle and rotator cuff disease. J Shoulder Elbow Surg. 1995 Nov-Dec;4(6):454-61. doi: 10.1016/s1058-2746(05)80038-2.
PubMed 8665291Barrett WP, Franklin JL, Jackins SE, Wyss CR, Matsen FA 3rd. Total shoulder arthroplasty. J Bone Joint Surg Am. 1987 Jul;69(6):865-72.
PubMed 3597500Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24.
PubMed 6839586Bigliani LU, Levine WN. Subacromial impingement syndrome. J Bone Joint Surg Am. 1997 Dec;79(12):1854-68. No abstract available.
PubMed 9409800Bretzke CA, Crass JR, Craig EV, Feinberg SB. Ultrasonography of the rotator cuff. Normal and pathologic anatomy. Invest Radiol. 1985 May-Jun;20(3):311-5. doi: 10.1097/00004424-198505000-00015.
PubMed 3897119BROWN JT. Early assessment of supraspinatus tears; procaine infiltration as a guide to treatment. J Bone Joint Surg Br. 1949 Aug;31B(3):423-5. No abstract available.
PubMed 18142154Budoff JE, Nirschl RP, Guidi EJ. Debridement of partial-thickness tears of the rotator cuff without acromioplasty. Long-term follow-up and review of the literature. J Bone Joint Surg Am. 1998 May;80(5):733-48. doi: 10.2106/00004623-199805000-00016. No abstract available.
PubMed 9611036Burkhart SS. Arthroscopic debridement and decompression for selected rotator cuff tears. Clinical results, pathomechanics, and patient selection based on biomechanical parameters. Orthop Clin North Am. 1993 Jan;24(1):111-23.
PubMed 8421604Burkhead WZ. Symposium: the rotator Cuff: debridement versus repair - part I. Contemporary Orthopedics 31:262-271, 1995.
Burkhead WZ. Symposium: the rotator Cuff: debridement versus repair - part II. Contemporary Orthopedics 31:313-326, 1995.
Butters KP, Rockwood CA Jr. Office evaluation and management of the shoulder impingement syndrome. Orthop Clin North Am. 1988 Oct;19(4):755-65.
PubMed 3050719Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. No abstract available.
PubMed 4019548
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00196573
- Acronym / sponsor ID
- FKSMC-AOSSM-1
- Conditions
- Tendinosis, Shoulder Impingement Syndrome
- Keywords
- Rotator Cuff, Tendinosis, Impingement Syndrome, Partial Thickness Tears, Rotator Cuff Tendinosis, Partial Thickness Rotator Cuff Tears
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Fowler Kennedy Sport Medicine Clinic
- Study start
- Nov 2003
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder bursectomy and acromioplasty | Active comparator | Procedure: Shoulder bursectomy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of stage II rotator cuff impingement syndrome defined as:
- 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:
- Patients willing to be followed on a regular basis
- Patients 18 years of age and older
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder bursectomy alone | Procedure or surgery | Shoulder bursectomy and acromioplasty |
Primary outcome
The Western Ontario Rotator Cuff (WORC) index
Time frame: Baseline, 2 & 6 weeks, 3, 6, 12, 18, 24 months
a disease specific quality of life measure for rotator cuff disease evaluated pre-operatively and at all post-operative visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
- Background: PubMed 2398090Altchek DW, Warren RF, Wickiewicz TL, Skyhar MJ, Ortiz G, Schwartz E. Arthroscopic acromioplasty. Technique and results. J Bone Joint Surg Am. 1990 Sep;72(8):1198-207.
- BackgroundAlvarez C, Kirkley A. The development of a disease specific quality of life measurement tool for rotator cuff disease. Presented at 23rd Clinical Seminar in Orthopaedic Surgery, London, Canada. May, 1995.
- Background: PubMed 4091915Andrews JR, Broussard TS, Carson WG. Arthroscopy of the shoulder in the management of partial tears of the rotator cuff: a preliminary report. Arthroscopy. 1985;1(2):117-22. doi: 10.1016/s0749-8063(85)80041-4.
- Background: PubMed 8665291Banas MP, Miller RJ, Totterman S. Relationship between the lateral acromion angle and rotator cuff disease. J Shoulder Elbow Surg. 1995 Nov-Dec;4(6):454-61. doi: 10.1016/s1058-2746(05)80038-2.
- Background: PubMed 3597500Barrett WP, Franklin JL, Jackins SE, Wyss CR, Matsen FA 3rd. Total shoulder arthroplasty. J Bone Joint Surg Am. 1987 Jul;69(6):865-72.
- Background: PubMed 6839586Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24.
- Background: PubMed 9409800Bigliani LU, Levine WN. Subacromial impingement syndrome. J Bone Joint Surg Am. 1997 Dec;79(12):1854-68. No abstract available.
- Background: PubMed 3897119Bretzke CA, Crass JR, Craig EV, Feinberg SB. Ultrasonography of the rotator cuff. Normal and pathologic anatomy. Invest Radiol. 1985 May-Jun;20(3):311-5. doi: 10.1097/00004424-198505000-00015.
- Background: PubMed 18142154BROWN JT. Early assessment of supraspinatus tears; procaine infiltration as a guide to treatment. J Bone Joint Surg Br. 1949 Aug;31B(3):423-5. No abstract available.
- Background: PubMed 9611036Budoff JE, Nirschl RP, Guidi EJ. Debridement of partial-thickness tears of the rotator cuff without acromioplasty. Long-term follow-up and review of the literature. J Bone Joint Surg Am. 1998 May;80(5):733-48. doi: 10.2106/00004623-199805000-00016. No abstract available.
- Background: PubMed 8421604Burkhart SS. Arthroscopic debridement and decompression for selected rotator cuff tears. Clinical results, pathomechanics, and patient selection based on biomechanical parameters. Orthop Clin North Am. 1993 Jan;24(1):111-23.
- BackgroundBurkhead WZ. Symposium: the rotator Cuff: debridement versus repair - part I. Contemporary Orthopedics 31:262-271, 1995.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Willits, MD, FRCS(C) principal investigator
Fowler Kennedy Sport Medicine Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shoulder bursectomy alone in people with Tendinosis and Shoulder Impingement Syndrome, run by University of Western Ontario, Canada at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Western Ontario Rotator Cuff (WORC) index (time frame: Baseline, 2 & 6 weeks, 3, 6, 12, 18, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00196573, which also lists 63 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2014.