Trial Outcomes & Findings for Lesser Tuberosity Osteotomy for Subscapularis Repair (NCT NCT02762903)

NCT ID: NCT02762903

Last Updated: 2024-08-06

Results Overview

Tendon healing/tuberosity union based on radiographs

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Post operative at 1 year
• Results posted on: 2024-08-06

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Sex/gender were not collected from participants.

Baseline characteristics by cohort

Measure	Tenotomy n=30 Participants 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.	Osteotomy n=30 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Customized 0-18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Customized At least 18 years old	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants
Sex: Female, Male Female	—	—	0 Participants Sex/gender were not collected from participants.
Sex: Female, Male Male	—	—	0 Participants Sex/gender were not collected from participants.

PRIMARY outcome

Timeframe: Post operative at 1 year

Population: Only includes participants who completed the final follow-up.

Tendon healing/tuberosity union based on radiographs

Outcome measures

Measure	Osteotomy n=29 Participants 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.	Tenotomy n=30 Participants 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.
Number of Subjects With Radiologic Evidence of Anatomic Healing	27 Participants	26 Participants

SECONDARY outcome

Timeframe: 1 year post-operatively

Population: Only includes participants who completed the final follow-up.

Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain. Mean score is reported without a range or standard deviation.

Outcome measures

Measure	Osteotomy n=29 Participants 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.	Tenotomy n=30 Participants 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.
Mean Visual Analogue Pain Scale (VAS)	1.8 score on a scale Standard Deviation NA The standard deviation 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.	1.9 score on a scale Standard Deviation NA The standard deviation 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.

SECONDARY outcome

Timeframe: 1 year post-operatively

Population: Only includes participants who completed the final follow-up.

Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength.

Outcome measures

Measure	Osteotomy n=29 Participants 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.	Tenotomy n=30 Participants 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.
Forward Elevation (FE) Strength	150 degrees Standard Deviation 6	153 degrees Standard Deviation 7

SECONDARY outcome

Timeframe: From incision time to time of complete skin closure

Population: Only includes participants who completed the final follow-up.

To be recorded in minutes, and documented by the surgical team

Outcome measures

Measure	Osteotomy n=29 Participants 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.	Tenotomy n=30 Participants 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.
Total Intra-Operative Time	152.7 minutes Standard Deviation NA The standard deviation 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.	129.3 minutes Standard Deviation NA The standard deviation 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.

SECONDARY outcome

Timeframe: From glenoid implantation to completion of tendon or osteotomy repair

Population: Only includes participants who completed the final follow-up.

To be recorded in minutes, and documented by the surgical team

Outcome measures

Measure	Osteotomy n=29 Participants 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.	Tenotomy n=30 Participants 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.
Total Subscapularis Repair Time (in Minutes)	39.3 minutes Standard Deviation NA The standard deviation 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.	34.3 minutes Standard Deviation NA The standard deviation 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.

SECONDARY outcome

Timeframe: 1 year post-operatively

Population: Only includes participants who completed the final follow-up.

Strength testing with Dynamometer in external rotation.

Outcome measures

Measure	Osteotomy n=29 Participants 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.	Tenotomy n=30 Participants 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.
External Rotation (ER) Strength	52 degrees Standard Deviation 3	50 degrees Standard Deviation 2

Adverse Events

Tenotomy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Osteotomy

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tenotomy n=30 participants at risk 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.	Osteotomy n=30 participants at risk 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.
Musculoskeletal and connective tissue disorders Tear of Supraspinatus	3.3% 1/30 • Number of events 1 • Up to 1 year after surgery.	0.00% 0/30 • Up to 1 year after surgery.
Musculoskeletal and connective tissue disorders Subacromial impingement	3.3% 1/30 • Number of events 1 • Up to 1 year after surgery.	0.00% 0/30 • Up to 1 year after surgery.
General disorders Pain	0.00% 0/30 • Up to 1 year after surgery.	3.3% 1/30 • Number of events 1 • Up to 1 year after surgery.
Musculoskeletal and connective tissue disorders Transient post-operative radial nerve palsy	0.00% 0/30 • Up to 1 year after surgery.	3.3% 1/30 • Number of events 1 • Up to 1 year after surgery.
Musculoskeletal and connective tissue disorders Subacromial bursitis	0.00% 0/30 • Up to 1 year after surgery.	6.7% 2/30 • Number of events 2 • Up to 1 year after surgery.
Musculoskeletal and connective tissue disorders Trapezius spasms	0.00% 0/30 • Up to 1 year after surgery.	3.3% 1/30 • Number of events 1 • Up to 1 year after surgery.

Additional Information

William N. Levine, MD

Columbia University

Phone: 212-305-0998

Email: wnl1@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place