Clinical Trials Logo

Clinical 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 of postoperative subscapularis muscle dysfunction and rupture as compared to those who receive the traditional tenotomy repair.


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT02762903
Study type Interventional
Source Columbia University
Contact
Status Completed
Phase N/A
Start date August 2009
Completion date June 2013

See also
  Status Clinical Trial Phase
Completed NCT04657926 - A Trial of APPA in the Treatment of Knee Osteoarthritis Phase 2
Completed NCT02536833 - A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects Phase 2
Completed NCT03014037 - Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration N/A
Recruiting NCT05937542 - A Qualitative Investigation of CLEAT Participants
Completed NCT03644615 - A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis N/A
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT03850665 - Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach N/A
Completed NCT02826902 - Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial N/A
Completed NCT04402502 - Dynamic 4DCT to Examine Wrist Carpal Mechanics N/A
Completed NCT02923700 - Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial Phase 4
Completed NCT04564053 - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants Phase 1
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Not yet recruiting NCT05036174 - Diphenhydramine Ointment for Knee Osteoarthritis N/A
Recruiting NCT02666443 - Low Dose Dexamethasone in Supraclavicular Blocks N/A
Recruiting NCT02912429 - Onlay vs. Inlay Patellofemoral Arthroplasty N/A
Active, not recruiting NCT02723929 - Effects of tDCS and tUS on Pain Perception in OA of the Knee
Terminated NCT02820766 - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting N/A
Withdrawn NCT02921594 - Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties N/A