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OsteoarthritisNCT01961986

Rotator Cuff Sparing Total Arthroplasty

A study testing TSR - traditional subscapularis release and TSR - rotator cuff sparing in people with Osteoarthritis and Inflammatory Arthritis, run by NYU Langone Health at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Design: Prospective, randomized clinical trial, of 120 patients requiring a total shoulder replacement (TSR). 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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Osteoarthritis, Inflammatory Arthritis
What is being tested?
TSR - traditional subscapularis release and TSR - rotator cuff sparing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteUnited States
Study dates
Jul 2010to 4 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is indicated for shoulder joint replacement
  • 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

Who cannot join

  • Prior arthroplasty in the affected shoulder.
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NYU Hospital for Joint Diseases

    New York, New York, 10003

Other trials in United States

About this study

Official title: Rotator Cuff Sparing Total Arthroplasty - A Prospective, Randomized Clinical Trial

Design: Prospective, randomized clinical trial, of 120 patients requiring a total shoulder replacement (TSR).

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).

Read the detailed description

Design: Prospective, randomized clinical trial, of 120 patients requiring a total shoulder replacement (TSR).

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.

Being tested
TSR - traditional subscapularis release, TSR - rotator cuff sparing
Keywords
Rotator Cuff, Rotator Cuff Sparing, Shoulder Replacement, Total Shoulder Replacement, Total Shoulder Arthroplasty, Arthritis
Medical subject headings
Osteoarthritis, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TSR - traditional subscapularis releaseProcedure or surgery

    Total Shoulder Replacement surgery performed using the traditional subscapularis release approach.

  • TSR - rotator cuff sparingProcedure or surgery

    Total Shoulder Replacement surgery performed using the rotator cuff sparing approach.

Study groups in NCT01961986
Study groupRoleWhat they receive
TSR: traditional subscap releaseActive comparatorTSR - traditional subscapularis release approach Subscapularis tendon release technique TSR
Receives: Procedure: TSR - traditional subscapularis release
TSR: rotator cuff sparingExperimentalRotator cuff sparing technique TSR
Receives: Procedure: TSR - rotator cuff sparing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Outcome

    Patient subjective and objective data will be collected for all patients using the Short Form 12 (SF-12)and Patient Assessment forms. From these forms, both American Shoulder and Elbow Society (ASES) outcome score and the Constant score can be derived to assess functional outcome. Additional data will also be collected specific to the integrity and the function of the subscapularis tendon that include the results of the "belly press" and the "lift off" test. They will be graded as "unable", "maintain against gravity", "maintain against resistance", and "full strength."

    Measured: Preoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2013 (estimated)
  2. Study startJul 2010
  3. Primary completion4 May 2017
  4. Study completion4 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01961986
Sponsor's protocol ID
10-02125
Status last verified
Dec 2025
First submitted
8 Oct 2013
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 16194737
  • 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.

    PubMed 19949123
  • 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.

    PubMed 16203880
  • 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.

    PubMed 11988723
  • 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.

    PubMed 16979047
  • 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.

    PubMed 16194740
  • 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.

    PubMed 12610483
  • 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.

    PubMed 16085613
  • 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.

    PubMed 18024179
  • 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.

    PubMed 19540778
  • 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.

    PubMed 8698718
  • 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.

    PubMed 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.

    PubMed 14564261

Questions about this trial

What is this clinical trial studying?

A study testing TSR - traditional subscapularis release and TSR - rotator cuff sparing in people with Osteoarthritis and Inflammatory Arthritis, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Outcome (time frame: Preoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01961986, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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Rotator Cuff Sparing Total Arthroplasty (NCT01961986) | AzTrials