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
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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).
- 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.
- 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)
Study has been discontinued
- 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).
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
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Aaron Chamberlain, MD||Washington University School of Medicine|