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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 degrees humeral component version | Experimental | Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version |
|
| 30 degrees humeral component retroversion | Experimental | Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0 degrees humeral component version | Device | RTSA with humeral component positioned in 0 degrees of version |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative External Range of Motion (ROM) | External range of motion measurements of the shoulder in degrees | 2 years |
| Postoperative Internal Range of Motion (ROM) | Internal range of motion measurements of the shoulder in degrees | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Revision arthroplasty
Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
Minors (under 18 years of age)
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| Name | Affiliation | Role |
|---|---|---|
| J. Michael Wiater, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Health | Royal Oak | Michigan | 48073 | United States |
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Of 95 patients recruited, 85 met inclusion criteria and were randomized to treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 30 Degrees Humeral Component Retroversion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative External Range of Motion (ROM) | External range of motion measurements of the shoulder in degrees | 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. | Posted | Mean | Standard Error | degrees | 2 years |
|
2 years
Only shoulder related adverse events were assessed and collected per protocol
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision Reverse Total Shoulder Arthroplasty | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heteroptopic ossification on inferior glenoid | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Sloan, Clinical Research Manager | William Beaumont Hospitals | 248-551-6059 | pamela.sloan@corewellhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2021 | Jan 11, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 16, 2022 | Jan 11, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 30 degrees humeral component retroversion | Device | RTSA with humeral component positioned in 30 degrees of retroversion |
|
| Protocol Violation |
|
| Death |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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
|
|
| Primary | Postoperative Internal Range of Motion (ROM) | Internal range of motion measurements of the shoulder in degrees | 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. | Posted | Mean | Standard Error | degrees | 2 years |
|
|
|
| 1 |
| 42 |
| 1 |
| 42 |
| 11 |
| 42 |
| EG001 | 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 | 1 | 43 | 3 | 43 | 9 | 43 |
| COVID Infection resulting in Death | Infections and infestations | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Impingement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Crepitus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Inferior Scapular Notching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Interval Bony Healing | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chronic changes to the distal acronium | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| New onset shoulder weakness | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Scapular spine tenderness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tendinitis (Deltoid) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture (Scapular body) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Numbness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Brachioplexopathy | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Limited Range of Motion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Muscle Spams | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| shoulder injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| humeral head subluxed inferiorly | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| elevated C-reactive protein | Injury, poisoning and procedural complications | Systematic Assessment |
|
| shoulder aspiration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lateral deltoid insertion pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shoulder strain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lucency around stem of humeral component | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ecchymosis of proximal arm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| new onset instability | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| positive sulcus sign | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| cortisone injection | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D000070657 |
| Crystal Arthropathies |