An interventional study of 0 degrees humeral component version and 30 degrees humeral component retroversion in Rotator Cuff Tear Arthropathy, sponsored by William Beaumont Hospitals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Treatment
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.
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.
52 studies on the registry are indexed under Rotator Cuff Tear Arthropathy; 15 are open to participants now.
This study's enrollment of 95 is close to the median of 93 across 29 interventional studies indexed under Rotator Cuff Tear Arthropathy.
Browse Rotator Cuff Tear Arthropathy studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Minors (under 18 years of age)
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
Device: 0 degrees humeral component version
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
Device: 30 degrees humeral component retroversion
RTSA with humeral component positioned in 0 degrees of version
RTSA with humeral component positioned in 30 degrees of retroversion
Postoperative External Range of Motion (ROM)
External range of motion measurements of the shoulder in degrees
Time frame: 2 years
Postoperative Internal Range of Motion (ROM)
Internal range of motion measurements of the shoulder in degrees
Time frame: 2 years
| Milestone | 0 Degrees Humeral Component Version | 30 Degrees Humeral Component Retroversion |
|---|---|---|
| Started | 42 | 43 |
| Completed | 33 | 33 |
| Not completed | 9 | 10 |
| Withdrew: Lost to follow-up | 2 | 5 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Death | 1 | 1 |
External range of motion measurements of the shoulder in degrees
| degrees | 0 Degrees Humeral Component Version | 30 Degrees Humeral Component Retroversion |
|---|---|---|
| Postoperative External Range of Motion (ROM) | 35 ± 3.4 | 39 ± 2.1 |
Internal range of motion measurements of the shoulder in degrees
| degrees | 0 Degrees Humeral Component Version | 30 Degrees Humeral Component Retroversion |
|---|---|---|
| Postoperative Internal Range of Motion (ROM) | 35.5 ± 3.2 | 33.5 ± 2.5 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0 Degrees Humeral Component Version | 1/42 (2.4%) | 1/42 (2.4%) | 11/42 (26.2%) |
| 30 Degrees Humeral Component Retroversion | 1/43 (2.3%) | 3/43 (7%) | 9/43 (20.9%) |
| Event | 0 Degrees Humeral Component Version | 30 Degrees Humeral Component Retroversion |
|---|---|---|
| Revision Reverse Total Shoulder ArthroplastySurgical and medical procedures | 0/42 | 2/43 |
| COVID Infection resulting in DeathInfections and infestations | 1/42 | 1/43 |
| Event | 0 Degrees Humeral Component Version | 30 Degrees Humeral Component Retroversion |
|---|---|---|
| PainMusculoskeletal and connective tissue disorders | 7/42 | 7/43 |
| Heteroptopic ossification on inferior glenoidInjury, poisoning and procedural complications | 0/42 | 3/43 |
| ImpingementMusculoskeletal and connective tissue disorders | 1/42 | 3/43 |
| CrepitusMusculoskeletal and connective tissue disorders | 2/42 | 1/43 |
| New onset shoulder weaknessInjury, poisoning and procedural complications | 2/42 | 2/43 |
| Limited Range of MotionInjury, poisoning and procedural complications | 2/42 | 0/43 |
| Inferior Scapular NotchingMusculoskeletal and connective tissue disorders | 1/42 | 1/43 |
| Fracture (Scapular body)Musculoskeletal and connective tissue disorders | 1/42 | 0/43 |
| NumbnessMusculoskeletal and connective tissue disorders | 1/42 | 1/43 |
| BrachioplexopathyInjury, poisoning and procedural complications | 1/42 | 0/43 |
| Age, Continuous(years) | 0 Degrees Humeral Component Version | 30 Degrees Humeral Component Retroversion | Total |
|---|---|---|---|
| Mean | 69.20 ± 8.21 | 69.19 ± 7.45 | 69.19 ± 7.78 |
| Sex: Female, Male(Participants) | 0 Degrees Humeral Component Version | 30 Degrees Humeral Component Retroversion | Total |
|---|---|---|---|
| Female | 23 | 31 | 54 |
| Male | 19 | 12 | 31 |
| Race and Ethnicity Not Collected(Participants) | 0 Degrees Humeral Component Version | 30 Degrees Humeral Component Retroversion | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | 0 Degrees Humeral Component Version | 30 Degrees Humeral Component Retroversion | Total |
|---|---|---|---|
| United States | 42 | 43 | 85 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Rotator Cuff Tear Arthropathy→
William Beaumont Hospitals