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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenotomy | Active Comparator | Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique. |
|
| Osteotomy | Active Comparator | Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSA with tenotomy technique | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Radiologic Evidence of Anatomic Healing | Tendon healing/tuberosity union based on radiographs | Post operative at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year post-operatively |
| Forward Elevation (FE) Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William N. Levine, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30771825 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tenotomy | Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique. TSA with tenotomy technique: 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. Shoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. |
| FG001 | Osteotomy | Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique. TSA with lesser tuberosity osteotomy technique: 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 prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tenotomy | Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique. TSA with tenotomy technique: 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. Shoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Radiologic Evidence of Anatomic Healing | Tendon healing/tuberosity union based on radiographs | Only includes participants who completed the final follow-up. | Posted | Count of Participants | Participants | Post operative at 1 year |
|
Up to 1 year after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tenotomy | Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique. TSA with tenotomy technique: 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. Shoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tear of Supraspinatus | Musculoskeletal and connective tissue disorders | Systematic Assessment | Partial-thickness, bursal-sided tear of the supraspinatus managed nonoperatively. |
The standard deviation for Outcome Measure #2,4,5 was not calculated. Raw data existed during the study period of 2009 to 2013. This record was completed and published in 2016 without results. The data was subsequently destroyed because the data retention period had ended. This study closed with the IRB in 2017 and further analysis cannot be conducted. As of the current year, 2024, all the raw data for this study no longer exists. The standard deviation cannot be calculated without the raw data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William N. Levine, MD | Columbia University | 212-305-0998 | wnl1@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C481298 | theasinensin A |
| D000072227 | Shoulder Prosthesis |
| ID | Term |
|---|---|
| D007595 | Joint Prosthesis |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| TSA with lesser tuberosity osteotomy technique | Procedure | 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 prosthesis | Device | Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. |
|
Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength.
| 1 year post-operatively |
| Total Intra-Operative Time | To be recorded in minutes, and documented by the surgical team | 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 | From glenoid implantation to completion of tendon or osteotomy repair |
| External Rotation (ER) Strength | Strength testing with Dynamometer in external rotation. | 1 year post-operatively |
| BG001 | Osteotomy | Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique. TSA with lesser tuberosity osteotomy technique: 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 prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Sex/gender were not collected from participants. | Count of Participants | Participants |
|
| OG001 |
| Osteotomy |
Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique. TSA with lesser tuberosity osteotomy technique: 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 prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. |
|
|
| Secondary | 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. | Only includes participants who completed the final follow-up. | Posted | Mean | Standard Deviation | score on a scale | 1 year post-operatively |
|
|
|
| Secondary | Forward Elevation (FE) Strength | Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength. | Only includes participants who completed the final follow-up. | Posted | Mean | Standard Deviation | degrees | 1 year post-operatively |
|
|
|
| Secondary | Total Intra-Operative Time | To be recorded in minutes, and documented by the surgical team | Only includes participants who completed the final follow-up. | Posted | Mean | Standard Deviation | minutes | From incision time to time of complete skin closure |
|
|
|
| Secondary | Total Subscapularis Repair Time (in Minutes) | To be recorded in minutes, and documented by the surgical team | Only includes participants who completed the final follow-up. | Posted | Mean | Standard Deviation | minutes | From glenoid implantation to completion of tendon or osteotomy repair |
|
|
|
| Secondary | External Rotation (ER) Strength | Strength testing with Dynamometer in external rotation. | Only includes participants who completed the final follow-up. | Posted | Mean | Standard Deviation | degrees | 1 year post-operatively |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Osteotomy | Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique. TSA with lesser tuberosity osteotomy technique: 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 prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device. | 0 | 30 | 0 | 30 | 5 | 30 |
|
| Subacromial impingement | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subacromial impingement requiring arthroscopic bursectomy and anterior acromioplasty |
|
| Pain | General disorders | Systematic Assessment | Pain developed at 3 months postoperatively owing to a loose cerclage wire, requiring hardware removal and lysis of adhesions. |
|
| Transient post-operative radial nerve palsy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Subacromial bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Trapezius spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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