N/A
N=60
Lesser Tuberosity Osteotomy for Subscapularis Repair
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02762903 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Number of Subjects With Radiologic Evidence of Anatomic Healing — 26; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TSA with tenotomy technique (Procedure); TSA with lesser tuberosity osteotomy technique (Procedure); Shoulder prosthesis (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Radiologic Evidence of Anatomic Healing |
26; 27 | — |
| SECONDARY Mean Visual Analogue Pain Scale (VAS) |
1.9; 1.8 | — |
| SECONDARY Forward Elevation (FE) Strength |
153; 150 | — |
| SECONDARY Total Intra-Operative Time |
129.3; 152.7 | — |
| SECONDARY Total Subscapularis Repair Time (in Minutes) |
34.3; 39.3 | — |
| SECONDARY External Rotation (ER) Strength |
50; 52 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02762903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.