Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
108 participants
INTERVENTIONAL
2010-07-31
2027-05-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Purpose: To collect and evaluate long-term clinical data on patients whose total shoulder replacement (TSR) is performed using the traditional surgical approach (called the subscapularis release approach) as compared to patients who have a TSR procedure done using a newer surgical approach (called the rotator cuff sparing approach).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis
NCT05395819
TSA vs RSA in Glenohumeral Osteoarthritis
NCT04228419
TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion
NCT05487274
Pectoralis Minor Release Versus Non-release in RSA
NCT06292169
Conservative or Operative Treatment for the Shoulder Impingement Syndrome?
NCT00349648
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Purpose: To collect and evaluate long-term clinical data on patients whose total shoulder replacement (TSR) is performed using the traditional surgical approach (called the subscapularis release approach) as compared to patients who have a TSR procedure done using a newer surgical approach (called the rotator cuff sparing approach).
For patients with arthritis, TSR can successfully improve pain and restore function. As a result, TSR has become the treatment of choice for patients with shoulder arthritis. Despite these generally good outcomes, however, there are concerns that rotator cuff function is suboptimal after surgery. One of the rotator cuff tendons is usually cut during the TSR procedure to insert the prosthesis and then repaired at the end of the surgery. If the tendon does not heal adequately, patients may experience persistent weakness, pain, and even failure of the replacement. Recently, a surgical technique called rotator cuff sparing TSR has been described where the procedure can be performed without ever cutting any of the rotator cuff tendons. As such, there should be minimized risk to the rotator cuff function after the surgery. Our study proposes to enroll two groups of patients with shoulder arthritis. The first group will be treated with the traditional TSR procedure. The second group will be treated with this new rotator cuff sparing surgical technique for TSR where the rotator cuff is never violated. After surgery, we will examine motion, strength, and functional use of the shoulder. In addition, we will specifically test the rotator cuff strength after the surgery. In this fashion, we plan to test the hypothesis that rotator cuff sparing TSR can improve the rotator cuff function while maintaining the excellent pain relief and motion that is normally observed after the traditional TSR procedure.
Enrollment: A total of approximately 120 subjects will be enrolled and treated at NYU Hospital for Joint Diseases. Subjects participating in the study will be randomly assigned to have their total shoulder replacement done using the traditional surgical approach (called the subscapularis release approach) or by the newer surgical approach (called the rotator cuff sparing approach). For each patient, a number will be created by a random number generator. Patients randomized to the even number (2) will receive a traditional TSA procedure that includes incision and repair of the subscapularis tendon during the procedure. Patients randomized to the odd number (1) will receive the rotator cuff sparing TSA. Regardless of the procedure, patients will remain "blind" to the type of procedure they received until completion of their 2 year follow up.
Follow-Up Requirements: Office Visits: Patients' participation will involve five (5) office visits (after surgery) over a period of two (2) years. At each visit, as part of the patients' regular care, they will have standard x-rays of their shoulder. All patients will complete self-administered questionnaires to assess the clinical outcome of the surgery and patients satisfaction. The patient administered outcome questionnaires will include the SF-12, and Patient Assessment Case Report Form.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TSR: traditional subscap release
TSR - traditional subscapularis release approach
Subscapularis tendon release technique TSR
TSR - traditional subscapularis release
Total Shoulder Replacement surgery performed using the traditional subscapularis release approach.
TSR: rotator cuff sparing
Rotator cuff sparing technique TSR
TSR - rotator cuff sparing
Total Shoulder Replacement surgery performed using the rotator cuff sparing approach.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TSR - traditional subscapularis release
Total Shoulder Replacement surgery performed using the traditional subscapularis release approach.
TSR - rotator cuff sparing
Total Shoulder Replacement surgery performed using the rotator cuff sparing approach.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient is at least 21 years of age
* Patient is expected to survive at least 2 years beyond surgery
* Patient is willing to participate by complying with pre-and post-operative visit requirements
* Patient is willing and able to review and sign a study informed consent form
Exclusion Criteria
* Significant deformity of the proximal humerus that requires a custom made implant or where osteotomy of the shaft and / or the tuberosity has to be considered.
* Significant medial erosion of the glenoid such that lateral edge of the humeral head lies medial to the lateral rim of the acromion.
* Significant injury to the brachial plexus
* Inability or unwillingness to participate in the post operative evaluation for the entire 24 months period.
* Pregnant and lactating women will be excluded
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NYU Langone Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Young W Kwon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Hospital for Joint Diseases
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NYU Hospital for Joint Diseases
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Deshmukh AV, Koris M, Zurakowski D, Thornhill TS. Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life. J Shoulder Elbow Surg. 2005 Sep-Oct;14(5):471-9. doi: 10.1016/j.jse.2005.02.009.
Khan A, Bunker TD, Kitson JB. Clinical and radiological follow-up of the Aequalis third-generation cemented total shoulder replacement: a minimum ten-year study. J Bone Joint Surg Br. 2009 Dec;91(12):1594-600. doi: 10.1302/0301-620X.91B12.22139.
Lo IK, Litchfield RB, Griffin S, Faber K, Patterson SD, Kirkley A. Quality-of-life outcome following hemiarthroplasty or total shoulder arthroplasty in patients with osteoarthritis. A prospective, randomized trial. J Bone Joint Surg Am. 2005 Oct;87(10):2178-85. doi: 10.2106/JBJS.D.02198.
Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002 Mar-Apr;11(2):130-5. doi: 10.1067/mse.2002.121146.
Armstrong A, Lashgari C, Teefey S, Menendez J, Yamaguchi K, Galatz LM. Ultrasound evaluation and clinical correlation of subscapularis repair after total shoulder arthroplasty. J Shoulder Elbow Surg. 2006 Sep-Oct;15(5):541-8. doi: 10.1016/j.jse.2005.09.013. Epub 2006 Jul 27.
Miller BS, Joseph TA, Noonan TJ, Horan MP, Hawkins RJ. Rupture of the subscapularis tendon after shoulder arthroplasty: diagnosis, treatment, and outcome. J Shoulder Elbow Surg. 2005 Sep-Oct;14(5):492-6. doi: 10.1016/j.jse.2005.02.013.
Miller SL, Hazrati Y, Klepps S, Chiang A, Flatow EL. Loss of subscapularis function after total shoulder replacement: A seldom recognized problem. J Shoulder Elbow Surg. 2003 Jan-Feb;12(1):29-34. doi: 10.1067/mse.2003.128195.
Gerber C, Yian EH, Pfirrmann CA, Zumstein MA, Werner CM. Subscapularis muscle function and structure after total shoulder replacement with lesser tuberosity osteotomy and repair. J Bone Joint Surg Am. 2005 Aug;87(8):1739-45. doi: 10.2106/JBJS.D.02788.
Qureshi S, Hsiao A, Klug RA, Lee E, Braman J, Flatow EL. Subscapularis function after total shoulder replacement: results with lesser tuberosity osteotomy. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1):68-72. doi: 10.1016/j.jse.2007.04.018. Epub 2007 Nov 19.
Lafosse L, Schnaser E, Haag M, Gobezie R. Primary total shoulder arthroplasty performed entirely thru the rotator interval: technique and minimum two-year outcomes. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):864-73. doi: 10.1016/j.jse.2009.03.017. Epub 2009 Jun 21.
Gerber C, Hersche O, Farron A. Isolated rupture of the subscapularis tendon. J Bone Joint Surg Am. 1996 Jul;78(7):1015-23. doi: 10.2106/00004623-199607000-00005.
Gerber C, Krushell RJ. Isolated rupture of the tendon of the subscapularis muscle. Clinical features in 16 cases. J Bone Joint Surg Br. 1991 May;73(3):389-94. doi: 10.1302/0301-620X.73B3.1670434.
Tokish JM, Decker MJ, Ellis HB, Torry MR, Hawkins RJ. The belly-press test for the physical examination of the subscapularis muscle: electromyographic validation and comparison to the lift-off test. J Shoulder Elbow Surg. 2003 Sep-Oct;12(5):427-30. doi: 10.1016/s1058-2746(03)00047-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10-02125
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.