Total vs. Reverse Shoulder Replacement: Pain Relief Two Years After Surgery - Full Text View

Purpose

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	Intervention
Arthritis	Device: Reverse Shoulder Arthroplasty Device: Total Shoulder Arthroplasty


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Total vs. Reverse Shoulder Replacement: a Prospective Randomized Trial

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

ASES Score [ Time Frame: 2 years after shoulder replacement ] [ Designated as safety issue: No ]
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.
WOOS Score [ Time Frame: 2 years after shoulder replacement ] [ Designated as safety issue: No ]
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:

shoulder strength and motion based on physican examination [ Time Frame: 2 years post shoulder replacement ] [ Designated as safety issue: No ]
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).


Estimated Enrollment:	34
Study Start Date:	November 2012
Estimated Study Completion Date:	November 2022
Estimated Primary Completion Date:	November 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).

Arms

Assigned Interventions

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).

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Eligibility


Ages Eligible for Study:	70 Years to 95 Years (Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Inc.

Investigators


Principal Investigator:	Aaron Chamberlain, MD	Washington University School of Medicine

More Information


Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01884077 History of Changes
Other Study ID Numbers:	201209102
Study First Received:	June 12, 2013
Last Updated:	December 7, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:


patient outcomes two years after shoulder replacement seventy years of age and older

ClinicalTrials.gov processed this record on September 26, 2016