Subscapularis InjuryNCT01404143
Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel
A study testing Subscapularis Tenotomy and subscapularis peel in people with Subscapularis Injury, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel. It is the investigators' hypothesis that a peel of the subscapularis will result in greater strength, a higher healing rate, and a greater improvement in shoulder… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Subscapularis Injury
- What is being tested?
- Subscapularis Tenotomy and subscapularis peel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Sep 2017
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Imaging, and intra-operative findings confirming advanced humeral head cartilage loss, and/glenoid cartilage loss.
- Ability to understand and adhere to rehab protocols and testing procedure
- Persistent pain and functional disability for at least 6 months and failure of 6 months of conservative treatment
- surgical arthroplasty patients
Who cannot join
- Active joint of systemic infection
- Significant muscle paralysis
- Rotator cuff tear arthropathy
- Pregnancy
- Charcot's arthropathy
- Major medical illness ( life expectancy less then 1 year or unacceptably high operative risk)
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- Patients unable to provide informed consent due to language barrier or mental status
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent
- Patients unwilling to be followed for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel: A Multicenter, Randomized Controlled
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel.
It is the investigators' hypothesis that a peel of the subscapularis will result in greater strength, a higher healing rate, and a greater improvement in shoulder function and quality of life following shoulder replacement.
Read the detailed description
The primary research question is to determine the difference in subscapularis strength between two different methods of subscapularis mobilization in shoulder arthroplasty: intra-substance division of the tendon "tenotomy" versus direct detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel". The primary outcome is strength as measured by a hand-held dynamometer in the belly-press position at one-year post operative. Secondary research questions include determination of the difference in disease specific quality of life between patients who undergo a subscapularis tenotomy versus subscapularis peel, as measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), Constant score and the ASES score at one year post-operatively. Finally, the healing rate of the subscapularis, as measured by ultrasound at 1 year post-operative will be determined.
- Conditions
- Subscapularis Injury
- Being tested
- Subscapularis Tenotomy, subscapularis peel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subscapularis TenotomyProcedure or surgery
After the deltopectoral approach is completed, the subscapularis tendon will be tenotomized one centimeter medial to its insertion on the lesser tuberosity. The tendon will be tagged for later repair. Repair will take place with a combination of transosseous sutures (3) placed in a mattress configuration through the area of exposed lesser tuberosity. In addition, a soft tissue tendon to tendon repair will be carried out using figure-8 stitches using #2 (heavy) non-absorbable suture (Ticron).
subscapularis peelProcedure or surgery
The subscapularis will be elevated from the lesser tuberosity. The tendon will be tagged with stay sutures for later reattachment (3 sutures in mattress configuration). Reapproximation will take place with three non-absorbable mattress sutures placed in a trans-osseous fashion through the bicipital groove, exiting the greater tuberosity and tied over a 4-hole mini-fragment plate.
| Study group | Role | What they receive |
|---|---|---|
| Subscapularis Tenotomy | Active comparator | This treatment group will undergo a technique that involves division of the tendon to gain access to the shoulder.
After the deltopectoral approach is completed, the subscapularis tendon will be tenotomized one centimeter medial to its insertion on the lesser tuberosity. Receives: Procedure: Subscapularis Tenotomy |
| Subscapularis Peel | Experimental | This treatment group will use a technique that involves elevation of the tendon off the bone in order to gain access to the shoulder.The subscapularis will be elevated from the lesser tuberosity. Receives: Procedure: subscapularis peel |
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel, as measured by a hand-held dynamometer in the belly-press position at one year post operative?
Measured: 12 months
Secondary outcomes (1)
Quality of life as measured by WORC, ASES and Constant
- What is the difference in disease specific quality of life between patients who undergo a subscapularis tenotomy versus peel, as measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) at one year post-operatively in patients who undergo shoulder arthroplasty?
- What is the difference in outcome as measured by the Constant score and the ASES score, at one year post operatively?
- What are the healing rates, as measured by ultrasound at 1 year post-operative?
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subscapularis InjuryStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Health Care London, Unity Health Toronto
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404143
- Sponsor's protocol ID
- 2011-352
- Status last verified
- May 2021
- First submitted
- 26 Jul 2011
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel: A Multicenter, Randomized Controlled
- ClinicalTrials.gov ID
- NCT01404143
- Acronym / sponsor ID
- 2011-352
- Conditions
- Subscapularis Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- St. Joseph's Health Care London, Unity Health Toronto
- Study start
- Aug 2011 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 27 Jul 2011 (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.
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel.
It is the investigators' hypothesis that a peel of the subscapularis will result in greater strength, a higher healing rate, and a greater improvement in shoulder function and quality of life following shoulder replacement.
Detailed description
The primary research question is to determine the difference in subscapularis strength between two different methods of subscapularis mobilization in shoulder arthroplasty: intra-substance division of the tendon "tenotomy" versus direct detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel". The primary outcome is strength as measured by a hand-held dynamometer in the belly-press position at one-year post operative. Secondary research questions include determination of the difference in disease specific quality of life between patients who undergo a subscapularis tenotomy versus subscapularis peel, as measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), Constant score and the ASES score at one year post-operatively. Finally, the healing rate of the subscapularis, as measured by ultrasound at 1 year post-operative will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subscapularis Tenotomy | Active comparator | Procedure: Subscapularis TenotomyThis treatment group will undergo a technique that involves division of the tendon to gain access to the shoulder. After the deltopectoral approach is completed, the subscapularis tendon will be tenotomized one centimeter medial to its insertion on the lesser tuberosity. |
| Subscapularis Peel | Experimental | Procedure: subscapularis peelThis treatment group will use a technique that involves elevation of the tendon off the bone in order to gain access to the shoulder.The subscapularis will be elevated from the lesser tuberosity. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Imaging, and intra-operative findings confirming advanced humeral head cartilage loss, and/glenoid cartilage loss.
- Ability to understand and adhere to rehab protocols and testing procedure
- Persistent pain and functional disability for at least 6 months and failure of 6 months of conservative treatment
- surgical arthroplasty patients
Key exclusion criteria (10 listed)
- Active joint of systemic infection
- Significant muscle paralysis
- Rotator cuff tear arthropathy
- Pregnancy
- Charcot's arthropathy
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 |
|---|---|---|
| Subscapularis TenotomyAfter the deltopectoral approach is completed, the subscapularis tendon will be tenotomized one centimeter medial to its insertion on the lesser tuberosity. The tendon will be tagged for later repair. Repair will take place with a combination of transosseous sutures (3) placed in a mattress configuration through the area of exposed lesser tuberosity. In addition, a soft tissue tendon to tendon repair will be carried out using figure-8 stitches using #2 (heavy) non-absorbable suture (Ticron). | Procedure or surgery | Subscapularis Tenotomy |
| subscapularis peelThe subscapularis will be elevated from the lesser tuberosity. The tendon will be tagged with stay sutures for later reattachment (3 sutures in mattress configuration). Reapproximation will take place with three non-absorbable mattress sutures placed in a trans-osseous fashion through the bicipital groove, exiting the greater tuberosity and tied over a 4-hole mini-fragment plate. | Procedure or surgery | Subscapularis Peel |
Primary outcome
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel
Time frame: 12 months
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel, as measured by a hand-held dynamometer in the belly-press position at one year post operative?
1 secondary outcome
Quality of life as measured by WORC, ASES and Constant
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
Peter Lapner, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subscapularis Tenotomy and subscapularis peel in people with Subscapularis Injury, run by Ottawa Hospital Research Institute at 1 site 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2021.