Rotator Cuff Tear Arthropathy
Conditions
Brief summary
The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
Detailed description
Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
Interventions
DEVICE0 degrees humeral component version
RTSA with humeral component positioned in 0 degrees of version
DEVICE30 degrees humeral component retroversion
RTSA with humeral component positioned in 30 degrees of retroversion
Sponsors
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing primary reverse total shoulder arthroplasty * Diagnosis of cuff tear arthropathy or primary OA with RCT * Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam * 18 years or older
Exclusion criteria
* Revision arthroplasty * Diagnosis of rheumatoid arthritis, infection, acute trauma or instability * Minors (under 18 years of age) * Prior open shoulder surgery * Concomitant latissimus dorsi transfer * Patients not undergoing a standard of care physical therapy protocol * Pregnant, patient-reported * Cognitively impaired
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative External Range of Motion (ROM) | 2 years | External range of motion measurements of the shoulder in degrees |
| Postoperative Internal Range of Motion (ROM) | 2 years | Internal range of motion measurements of the shoulder in degrees |
Countries
United States
Participant flow
Pre-assignment details
Of 95 patients recruited, 85 met inclusion criteria and were randomized to treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| 0 Degrees Humeral Component Version Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
0 degrees humeral component version: RTSA with humeral component positioned in 0 degrees of version | 42 |
| 30 Degrees Humeral Component Retroversion Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
30 degrees humeral component retroversion: RTSA with humeral component positioned in 30 degrees of retroversion | 43 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 5 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | 30 Degrees Humeral Component Retroversion | Total | 0 Degrees Humeral Component Version |
|---|---|---|---|
| Age, Continuous | 69.19 years STANDARD_DEVIATION 7.45 | 69.19 years STANDARD_DEVIATION 7.78 | 69.20 years STANDARD_DEVIATION 8.21 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 43 Participants | 85 Participants | 42 Participants |
| Sex: Female, Male Female | 31 Participants | 54 Participants | 23 Participants |
| Sex: Female, Male Male | 12 Participants | 31 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 42 | 1 / 43 |
| other Total, other adverse events | 11 / 42 | 9 / 43 |
| serious Total, serious adverse events | 1 / 42 | 3 / 43 |
Outcome results
Primary
Postoperative External Range of Motion (ROM)
External range of motion measurements of the shoulder in degrees
Time frame: 2 years
Population: 9 participants in the 0 degrees humeral component version and 10 patients in the 30 degrees humeral component retroversion did not complete study activities and no data was collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 Degrees Humeral Component Version | Postoperative External Range of Motion (ROM) | 35 degrees | Standard Error 3.4 |
| 30 Degrees Humeral Component Retroversion | Postoperative External Range of Motion (ROM) | 39 degrees | Standard Error 2.1 |
Primary
Postoperative Internal Range of Motion (ROM)
Internal range of motion measurements of the shoulder in degrees
Time frame: 2 years
Population: 9 participants in the 0 degrees humeral component version and 10 patients in the 30 degrees humeral component retroversion did not complete study activities and no data was collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 Degrees Humeral Component Version | Postoperative Internal Range of Motion (ROM) | 35.5 degrees | Standard Error 3.2 |
| 30 Degrees Humeral Component Retroversion | Postoperative Internal Range of Motion (ROM) | 33.5 degrees | Standard Error 2.5 |