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

NCT03599336 | Terminated

• 1 other identifier: 18-002097
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nonoperative Treatment

OTHER

Subjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts.

Other: Nonoperative Treatment

Operative Course for rTSA

OTHER

Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts.

Procedure: Reverse Total Shoulder Arthroplasty (rTSA)

Interventions

Reverse Total Shoulder Arthroplasty (rTSA) PROCEDURE

Surgical management will include placement of fracture specific, cemented reverse total shoulder arthroplasty components as per standard surgical care and routine postoperative rehabilitation.

Operative Course for rTSA

Nonoperative Treatment OTHER

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.

Nonoperative Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Displaced 3- and 4-part proximal humerus fractures.
• Age greater than or equal to 65 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

  PMID: 35727196 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Humeral Fractures; Shoulder Fractures; Shoulder Injuries; Joint Diseases

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone; Musculoskeletal Diseases

Study Officials

• Jonathan D Barlow

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2018
• First Posted: July 26, 2018
• Study Start: August 1, 2018
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

US (1)