Lesser Tuberosity Osteotomy for Subscapularis Repair

Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02762903

Enrollment

Registered

2016-05-05

Start date

2009-08-31

Completion date

2013-06-30

Last updated

2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Shoulder arthroplasty, Lesser Tuberosity Osteotomy, Subscapularis tenotomy

Brief 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 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.

Interventions

PROCEDURETSA 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.

PROCEDURETSA 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.

DEVICEShoulder prosthesis

Standard procedure: Total shoulder arthroplasty replaces both components of the ball and socket joint with a metal device.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients already scheduled for total shoulder arthroplasty

Exclusion criteria

* Unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With Radiologic Evidence of Anatomic Healing	Post operative at 1 year	Tendon healing/tuberosity union based on radiographs

Secondary

Measure	Time frame	Description
Mean Visual Analogue Pain Scale (VAS)	1 year post-operatively	Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain. Mean score is reported without a range or standard deviation.
Forward Elevation (FE) Strength	1 year post-operatively	Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength.
Total Intra-Operative Time	From incision time to time of complete skin closure	To be recorded in minutes, and documented by the surgical team
Total Subscapularis Repair Time (in Minutes)	From glenoid implantation to completion of tendon or osteotomy repair	To be recorded in minutes, and documented by the surgical team
External Rotation (ER) Strength	1 year post-operatively	Strength testing with Dynamometer in external rotation.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	30
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.	30
Total	60

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	1

Baseline characteristics

Characteristic	Tenotomy	Osteotomy	Total
Age, Customized 0-18 years	0 Participants	0 Participants	0 Participants
Age, Customized At least 18 years old	30 Participants	30 Participants	60 Participants
Sex: Female, Male Female	—	—	0 Participants
Sex: Female, Male Male	—	—	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 30
other Total, other adverse events	2 / 30	5 / 30
serious Total, serious adverse events	0 / 30	0 / 30

Outcome results

Primary