Trial Outcomes & Findings for Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty (NCT NCT00508105)
NCT ID: NCT00508105
Last Updated: 2020-05-05
Results Overview
Subscapularis muscle strength will be measured with an electronic handheld dynamometer. Patients are asked to press the dynamometer in towards their chest (belly-press) for a period of approximately 3 seconds before releasing. Strength is measured in kilograms of force.
COMPLETED
NA
87 participants
2 years
2020-05-05
Participant Flow
Participant milestones
| Measure |
Subscapularis Peel
Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel".
|
Osteotomy
osteotomy: This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
COMPLETED
|
40
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subscapularis Peel
n=44 Participants
Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel".
|
Osteotomy
n=43 Participants
osteotomy: This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=87 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=44 Participants
|
11 Participants
n=43 Participants
|
38 Participants
n=87 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=44 Participants
|
32 Participants
n=43 Participants
|
49 Participants
n=87 Participants
|
|
Age, Continuous
|
70.4 years
n=44 Participants
|
65.3 years
n=43 Participants
|
67.8 years
n=87 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=44 Participants
|
27 Participants
n=43 Participants
|
53 Participants
n=87 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=44 Participants
|
16 Participants
n=43 Participants
|
34 Participants
n=87 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
44 Participants
n=44 Participants
|
43 Participants
n=43 Participants
|
87 Participants
n=87 Participants
|
PRIMARY outcome
Timeframe: 2 yearsSubscapularis muscle strength will be measured with an electronic handheld dynamometer. Patients are asked to press the dynamometer in towards their chest (belly-press) for a period of approximately 3 seconds before releasing. Strength is measured in kilograms of force.
Outcome measures
| Measure |
Osteotomy
n=43 Participants
|
Subscapularis Peel
n=44 Participants
|
|---|---|---|
|
Subscapularis Strength
|
4.4 kg
Standard Deviation 2.9
|
5.5 kg
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 2 YearsThe Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
Outcome measures
| Measure |
Osteotomy
n=43 Participants
|
Subscapularis Peel
n=44 Participants
|
|---|---|---|
|
Western Ontario Osteoarthritis of the Shoulder Index
|
86.5 WOOS Score
Standard Deviation 16
|
88.2 WOOS Score
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: 2 YearsThe ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
Outcome measures
| Measure |
Osteotomy
n=43 Participants
|
Subscapularis Peel
n=44 Participants
|
|---|---|---|
|
American Shoulder and Elbow Score
|
79.4 ASES Score
Standard Deviation 24.6
|
83.3 ASES Score
Standard Deviation 19
|
Adverse Events
Subscapularis Peel
Osteotomy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place