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

NCT03599336 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-10-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Jonathan D Barlow · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-10-29
Completion
2020-10-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03599336 on ClinicalTrials.gov