Rotator Cuff Sparing Total Arthroplasty

NCT01961986 | Active Not Recruiting

• 1 other identifier: 10-02125
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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 compared to patients who have a TSR procedure done using a newer surgical approach (called the rotator cuff sparing approach).

Conditions

Osteoarthritis; Inflammatory Arthritis

Keywords

Rotator Cuff; Rotator Cuff Sparing; Shoulder Replacement; Total Shoulder Replacement; Total Shoulder Arthroplasty; Arthritis

Outcome Measures

Primary Outcomes (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."

  Preoperatively

Study Arms (2)

TSR: traditional subscap release

ACTIVE COMPARATOR

TSR - traditional subscapularis release approach Subscapularis tendon release technique TSR

Procedure: TSR - traditional subscapularis release

TSR: rotator cuff sparing

EXPERIMENTAL

Rotator cuff sparing technique TSR

Procedure: TSR - rotator cuff sparing

Interventions

TSR - traditional subscapularis release PROCEDURE

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

TSR: traditional subscap release

TSR - rotator cuff sparing PROCEDURE

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

TSR: rotator cuff sparing

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Related Publications (13)

• 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.

  PMID: 16194737 BACKGROUND

• 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.

  PMID: 19949123 BACKGROUND

• 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.

  PMID: 16203880 BACKGROUND

• 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.

  PMID: 11988723 BACKGROUND

• 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.

  PMID: 16979047 BACKGROUND

• 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.

  PMID: 16194740 BACKGROUND

• 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.

  PMID: 12610483 BACKGROUND

• 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.

  PMID: 16085613 BACKGROUND

• 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.

  PMID: 18024179 BACKGROUND

• 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.

  PMID: 19540778 BACKGROUND

• 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.

  PMID: 8698718 BACKGROUND

• 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.

  PMID: 1670434 BACKGROUND

• 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.

  PMID: 14564261 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Young W Kwon, MD, PhD

  NYU Hospital for Joint Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 14, 2013
• Study Start: July 1, 2010
• Primary Completion: May 4, 2017
• Study Completion (Estimated): May 4, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

US (1)