Trials / Terminated
TerminatedNCT03599336
RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures
Reverse Total Shoulder Arthroplasty Versus Nonoperative Treatment of 3 & 4-Part Proximal Humerus Fractures
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. No surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. This study is being performed to evaluate the differences in short- and long-term pain and functional outcomes between patients who are treated with these two different options.
Conditions
- Humerus Fracture
- Humerus
- Shoulder Fractures
- Shoulder Arthropathy Associated With Other Conditions
- Arthropathy Shoulder
- Shoulder Injury
- Arthropathy
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Reverse Total Shoulder Arthroplasty (rTSA) | Surgical management will include placement of fracture specific, cemented reverse total shoulder arthroplasty components as per standard surgical care and routine postoperative rehabilitation. |
| OTHER | Nonoperative Treatment | Subjects allocated to the nonoperative treatment arm will maintain sling immobilization for 3 weeks. The sling will be removed for elbow, wrist and hand range of motion (ROM), hygiene, and dressing only. At 3 weeks passive ROM in external rotation (ER) and forward elevation (FE) will be added. At 6 weeks from injury, the sling will be removed and stretching in all planes will be allowed. Use of the arm will be up to a fork/knife/toothbrush only. At 3 months from injury, strengthening will be added. Supervised physical therapy will be offered to patients for use at their discretion, as is current practice. |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2020-10-29
- Completion
- 2020-10-29
- First posted
- 2018-07-26
- Last updated
- 2021-10-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03599336. Inclusion in this directory is not an endorsement.