Trial Outcomes & Findings for Total vs. Reverse Shoulder Replacement: Pain Relief Two Years After Surgery (NCT NCT01884077)
NCT ID: NCT01884077
Last Updated: 2018-12-05
Results Overview
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.
TERMINATED
NA
19 participants
2 years after shoulder replacement
2018-12-05
Participant Flow
Participant milestones
| Measure |
Reverse Shoulder Arthroplasty
Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder
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.
|
Total Shoulder Arthroplasty
Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint
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).
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
11
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Reverse Shoulder Arthroplasty
Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder
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.
|
Total Shoulder Arthroplasty
Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint
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).
|
|---|---|---|
|
Overall Study
screen fail
|
0
|
2
|
|
Overall Study
canceled surgery
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
study closed
|
6
|
4
|
Baseline Characteristics
Total vs. Reverse Shoulder Replacement: Pain Relief Two Years After Surgery
Baseline characteristics by cohort
| Measure |
Reverse Shoulder Arthroplasty
n=8 Participants
Shoulder Joint Replacement Reverse Arthroplasty Implant to surgically replace arthritic shoulder
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.
|
Total Shoulder Arthroplasty
n=11 Participants
Shoulder Joint Replacement Total Arthroplasty Implant used to surgically replace osteoarthritic shoulder joint
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).
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
72 years
n=5 Participants
|
77 years
n=7 Participants
|
75.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years after shoulder replacementPopulation: This study has been discontinued and data was not sufficiently collected for any participant.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 years after shoulder replacementPopulation: This study has been discontinued. This study has been discontinued and data was not sufficiently collected for any participant.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 years post shoulder replacementPopulation: This study has been discontinued. This study has been discontinued and data was not sufficiently collected for any participant.
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).
Outcome measures
Outcome data not reported
Adverse Events
Reverse Shoulder Arthroplasty
Total Shoulder Arthroplasty
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Aaron Chamberlain
Washington University School of Medicine - Dept of Orthopaedic Surgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place