OsteoarthritisNCT02762903
Lesser Tuberosity Osteotomy for Subscapularis Repair
A study testing TSA with tenotomy technique, TSA with lesser tuberosity osteotomy technique and Shoulder prosthesis in people with Osteoarthritis, run by Columbia University at 1 site in United States.
Trial summary
The primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement. The investigators hypothesize that participants who receive a newer repair technique called a lesser tuberosity osteotomy will have lower rates… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- TSA with tenotomy technique, TSA with lesser tuberosity osteotomy technique and Shoulder prosthesis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients already scheduled for total shoulder arthroplasty
Who cannot join
- Unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty
The primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement. The investigators hypothesize that participants who receive a newer repair technique called a lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle dysfunction and rupture as compared to those who receive the traditional tenotomy repair.
Read the detailed description
The subscapularis tendon is mobilized during total shoulder arthroplasty in order to gain anterior access to the glenohumeral joint. Postoperative subscapularis dysfunction is being recognized more frequently and has been reported in >65% of patients following shoulder arthroplasty with a soft-tissue repair. Subscapularis dysfunction has been associated with poor functional outcomes including tendon rupture and anterior instability, a major indication for revision surgery. Recent studies suggest that a standard subscapularis tenotomy with primary tendon repair may lead to failure of the repair and decreased functional outcomes as compared to a more novel lesser tuberosity osteotomy technique. The investigators study aims to validate the results of the current literature in a prospective randomized controlled trial, which to their knowledge has not been reported on this topic.Investigators will compare clinical outcomes following these two techniques during total shoulder arthroplasty. Participants undergoing total shoulder replacement will be randomized to receive either a lesser tuberosity osteotomy or tenotomy with primary subscapularis tendon repair. All other procedures conducted in this study are considered standard of care except for ultrasounds, which are conducted for research purposes in the subscapularis tenotomy group. Postoperative outcomes will be monitored objectively and subjectively at routine postoperative office visits using physical exam, imaging (X-rays and ultrasounds), and questionnaires. If the hypothesis is proven to be true, the investigators will establish gold-standard evidence for the use of the newer osteotomy technique to improve patient satisfaction and mobility following shoulder arthroplasty.
- Conditions
- Osteoarthritis
- Being tested
- TSA with tenotomy technique, TSA with lesser tuberosity osteotomy technique, Shoulder prosthesis
- Keywords
- Shoulder arthroplasty, Lesser Tuberosity Osteotomy, Subscapularis tenotomy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSA with tenotomy techniqueProcedure or surgery
Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.
TSA with lesser tuberosity osteotomy techniqueProcedure or surgery
Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.
Shoulder prosthesisDevice
Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.
| Study group | Role | What they receive |
|---|---|---|
| Tenotomy | Active comparator | Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique. Receives: Procedure: TSA with tenotomy technique; Device: Shoulder prosthesis |
| Osteotomy | Active comparator | Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique. Receives: Procedure: TSA with lesser tuberosity osteotomy technique; Device: Shoulder prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Radiologic Evidence of Anatomic Healing
Tendon healing/tuberosity union based on radiographs
Measured: Post operative at 1 year
Secondary outcomes (5)
Mean Visual Analogue Pain Scale (VAS)
Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain. Mean score is reported without a range or standard deviation.
Measured: 1 year post-operatively
Forward Elevation (FE) Strength
Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength.
Measured: 1 year post-operatively
Total Intra-Operative Time
To be recorded in minutes, and documented by the surgical team
Measured: From incision time to time of complete skin closure
Total Subscapularis Repair Time (in Minutes)
To be recorded in minutes, and documented by the surgical team
Measured: From glenoid implantation to completion of tendon or osteotomy repair
External Rotation (ER) Strength
Strength testing with Dynamometer in external rotation.
Measured: 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startAug 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William N. Levine, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762903
- Sponsor's protocol ID
- AAAE1446
- Status last verified
- Jul 2024
- First submitted
- 19 Apr 2016
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Levine WN, Munoz J, Hsu S, Byram IR, Bigliani LU, Ahmad CS, Kongmalai P, Shillingford JN. Subscapularis tenotomy versus lesser tuberosity osteotomy during total shoulder arthroplasty for primary osteoarthritis: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2019 Mar;28(3):407-414. doi: 10.1016/j.jse.2018.11.057.
PubMed 30771825
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT02762903
- Acronym / sponsor ID
- AAAE1446
- Conditions
- Osteoarthritis
- Keywords
- Shoulder arthroplasty, Lesser Tuberosity Osteotomy, Subscapularis tenotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement. The investigators hypothesize that participants who receive a newer repair technique called a lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle dysfunction and rupture as compared to those who receive the traditional tenotomy repair.
Detailed description
The subscapularis tendon is mobilized during total shoulder arthroplasty in order to gain anterior access to the glenohumeral joint. Postoperative subscapularis dysfunction is being recognized more frequently and has been reported in >65% of patients following shoulder arthroplasty with a soft-tissue repair. Subscapularis dysfunction has been associated with poor functional outcomes including tendon rupture and anterior instability, a major indication for revision surgery. Recent studies suggest that a standard subscapularis tenotomy with primary tendon repair may lead to failure of the repair and decreased functional outcomes as compared to a more novel lesser tuberosity osteotomy technique. The investigators study aims to validate the results of the current literature in a prospective randomized controlled trial, which to their knowledge has not been reported on this topic.Investigators will compare clinical outcomes following these two techniques during total shoulder arthroplasty. Participants undergoing total shoulder replacement will be randomized to receive either a lesser tuberosity osteotomy or tenotomy with primary subscapularis tendon repair. All other procedures conducted in this study are considered standard of care except for ultrasounds, which are conducted for research purposes in the subscapularis tenotomy group. Postoperative outcomes will be monitored objectively and subjectively at routine postoperative office visits using physical exam, imaging (X-rays and ultrasounds), and questionnaires. If the hypothesis is proven to be true, the investigators will establish gold-standard evidence for the use of the newer osteotomy technique to improve patient satisfaction and mobility following shoulder arthroplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenotomy | Active comparator | Procedure: TSA with tenotomy technique, Device: Shoulder prosthesisSubjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique. |
| Osteotomy | Active comparator | Procedure: TSA with lesser tuberosity osteotomy technique, Device: Shoulder prosthesisSubjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients already scheduled for total shoulder arthroplasty
Key exclusion criteria (1 listed)
- Unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).
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 |
|---|---|---|
| TSA with tenotomy techniqueStandard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures. | Procedure or surgery | Tenotomy |
| TSA with lesser tuberosity osteotomy techniqueStandard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures. | Procedure or surgery | Osteotomy |
| Shoulder prosthesisStandard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. | Device | Osteotomy, Tenotomy |
Primary outcome
Number of Subjects With Radiologic Evidence of Anatomic Healing
Time frame: Post operative at 1 year
Tendon healing/tuberosity union based on radiographs
5 secondary outcomes
Mean Visual Analogue Pain Scale (VAS)
Time frame: 1 year post-operatively
Forward Elevation (FE) Strength
Time frame: 1 year post-operatively
Total Intra-Operative Time
Time frame: From incision time to time of complete skin closure
Total Subscapularis Repair Time (in Minutes)
Time frame: From glenoid implantation to completion of tendon or osteotomy repair
External Rotation (ER) Strength
Time frame: 1 year post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30771825Levine WN, Munoz J, Hsu S, Byram IR, Bigliani LU, Ahmad CS, Kongmalai P, Shillingford JN. Subscapularis tenotomy versus lesser tuberosity osteotomy during total shoulder arthroplasty for primary osteoarthritis: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2019 Mar;28(3):407-414. doi: 10.1016/j.jse.2018.11.057.
- Individual participant dataSharing planned: No
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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.
William N. Levine, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TSA with tenotomy technique, TSA with lesser tuberosity osteotomy technique and Shoulder prosthesis in people with Osteoarthritis, run by Columbia University at 1 site in United States.
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 1 inclusion and 1 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 6 Aug 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Radiologic Evidence of Anatomic Healing (time frame: Post operative at 1 year). 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 NCT02762903, which also lists 1 linked publication.
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 6 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.