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Rotator Cuff Sparing Total Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01961986
Recruitment Status : Active, not recruiting
First Posted : October 14, 2013
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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).


Condition or disease Intervention/treatment Phase
Osteoarthritis Inflammatory Arthritis Procedure: TSR - traditional subscapularis release Procedure: TSR - rotator cuff sparing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rotator Cuff Sparing Total Arthroplasty - A Prospective, Randomized Clinical Trial
Actual Study Start Date : July 2010
Actual Primary Completion Date : May 4, 2017
Estimated Study Completion Date : May 4, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TSR: traditional subscap release

TSR - traditional subscapularis release approach

Subscapularis tendon release technique TSR

Procedure: TSR - traditional subscapularis release
Total Shoulder Replacement surgery performed using the traditional subscapularis release approach.

Experimental: TSR: rotator cuff sparing
Rotator cuff sparing technique TSR
Procedure: TSR - rotator cuff sparing
Total Shoulder Replacement surgery performed using the rotator cuff sparing approach.




Primary Outcome Measures :
  1. Functional Outcome [ Time Frame: Preoperatively ]
    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."



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961986


Locations
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United States, New York
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Young W Kwon, MD, PhD NYU Hospital for Joint Diseases

Publications:

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01961986    
Other Study ID Numbers: 10-02125
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Rotator Cuff
Rotator Cuff Sparing
Shoulder Replacement
Total Shoulder Replacement
Total Shoulder Arthroplasty
Arthritis
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases