RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures

Arthropathy Clinical Trial

Official title:

Reverse Total Shoulder Arthroplasty Versus Nonoperative Treatment of 3 & 4-Part Proximal Humerus Fractures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03599336
• Other study ID #: 18-002097
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: October 29, 2020

Study information

• Verified date: October 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion criteria

• Displaced 3- and 4-part proximal humerus fractures.
• Age greater than or equal to 65 years old. Exclusion Criteria
• Less than 65 years old.
• Medical comorbidities precluding surgical treatment or anesthesia
• Dementia or inability to provide adequate follow up.
• Pathologic fractures
• Open fractures
• Associated injuries: fracture dislocations, multiple or complex injuries of the ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.

Related Conditions & MeSH terms

• Arthropathy
• Arthropathy Shoulder
• Fractures, Bone
• Humeral Fractures
• Humerus
• Humerus Fracture
• Joint Diseases
• Shoulder Arthropathy Associated With Other Conditions
• Shoulder Fractures
• Shoulder Injuries
• Shoulder Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function as described by ASES score at 1 year follow-up.	The American Shoulder and Elbow Surgeons (ASES) score is a well-validated, patient-reported outcome measure used by shoulder and elbow surgeons. The score ranges from 0-100 with 100 signifying the best outcome. Half of the score correlates to pain and half to function, both on a 0-50 scale where higher is again considered a better outcome. The pain portion is tabulated by taking the patient's response on a visual analogue scale (0 to 10 scale where 0 represent no pain and 10 represents worst pain imaginable), subtracting it from 10, and then multiplying by 5. The function score is tabulated by taking the patient's response on 10 questions rated on an ordinal scale from 0-3 and then multiplying the cumulative score by 5/3.	2 year follow-up

External Links

•   Mayo Clinic Clinical Trials