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Total vs. Reverse Shoulder Replacement: Pain Relief Two Years After Surgery

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ClinicalTrials.gov Identifier: NCT01884077
Recruitment Status : Terminated (slow recruitment and poor follow up)
First Posted : June 21, 2013
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:

Specific Aim: To compare early postoperative pain relief in patients over the age of 70 who undergo either Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty in treatment of glenohumeral osteoarthritis.

Hypothesis: Early postoperative pain relief will be greater in those undergoing Reverse Shoulder Arthroplasty.


Condition or disease Intervention/treatment Phase
Arthritis Device: Reverse Shoulder Arthroplasty Device: Total Shoulder Arthroplasty Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Total vs. Reverse Shoulder Replacement: a Prospective Randomized Trial
Study Start Date : November 2012
Actual Primary Completion Date : January 28, 2015
Actual Study Completion Date : June 2016
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Reverse Shoulder Arthroplasty
Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder
 Device: Total Shoulder Arthroplasty
TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component.
Active Comparator: Total Shoulder Arthroplasty
Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint
 Device: Reverse Shoulder Arthroplasty
REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus).


Outcome Measures
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Primary Outcome Measures :
  1. ASES Score [ Time Frame: 2 years after shoulder replacement ]
    American Shoulder & Elbow Survey (ASES): Assessment of patient-rated shoulder pain and function/disability. Questions involve activities of daily living that reflect the use of the shoulder & elbow in different planes of motion. Pain and weakness with various activities are also addressed. ASES score will be calculated, compared and reported for both groups pre-operatively and 2 years post operatively: (17 patients) total arthroplasty and (17 patients) reverse arthroplasty.

  2. WOOS Score [ Time Frame: 2 years after shoulder replacement ]
    a disease-specific quality-of-life instrument (Western Ontario Osteoarthritis of the Shoulder [WOOS]. WOOS Score will be generated for both groups pre-operatively and 2 years post operatively: Reverse arthroplasty(17 patients) and Total arthroplasty (17 patients)


Secondary Outcome Measures :
  1. shoulder strength and motion based on physican examination [ Time Frame: 2 years post shoulder replacement ]
    Research team member measures both shoulder range of motion (using a goniometer) and strength based on the standardized American Shoulder and Elbow Surgeons Society (ASES)examination. Physical Examination includes the following: forward elevation, external rotation, internal rotation, external rotation at side, Internal rotation extension with lift off exam, Horn Blower's, external rotation strength, thumb down abduction strength, abdominal compression test, Biceps rupture, Speeds Test, and Yergason's Test. External and Thumb Down abduction are measured with Iso-Force machine. Preoperative and 2 year post-operative range of motion and strength measurement score averages will be compared and reported for both groups (total 34 patients).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 95 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 70 or older,
  • have radiographic signs of osteoarthritis (narrowing of the glenohumeral joint space, marginal osteophytes around the humeral head, progressive changes with sclerosis and subcortical cystic formation and flattening of the humeral head),
  • intact rotator cuff but with atrophy or fatty degeneration (defined as Grade II atrophy noted on preoperative shoulder ultrasound),
  • objective weakness as measured with Isobex testing,
  • limited forward elevation (less than 90 degrees)

Exclusion Criteria:

  • patients who present with pain secondary to inflammatory arthropathy,
  • obvious full-thickness rotator cuff tear,
  • cuff tear arthropathy,
  • revision arthroplasty,
  • fracture or trauma,
  • patients who had previous rotator cuff repair or prior open surgery prior to shoulder arthroplasty.
  • pregnancy
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01884077


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Zimmer Biomet
Investigators
Principal Investigator: Aaron Chamberlain, MD Washington University School of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01884077     History of Changes
Other Study ID Numbers: 201209102
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Washington University School of Medicine:
patient outcomes two years after shoulder replacement
seventy years of age and older