Rehabilitation Following Displaced Proximal Humerus Fractures

NCT05302089 | Completed DMC

• 1 other identifier: PHF_rehab
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Proximal humerus fractures (PHFs) are the third most common non-vertebral fractures in the elderly. Most elderly experience loss of function following a PHF regardless of treatment. A Cochrane review from 2015 concluded that surgical management is not superior to non-surgical management, and that the optimal non-surgical management after PHF is not known. Therefore, the aim of this study is to evaluate the effectiveness of usual rehabilitation care after displaced PHF compared with one-time physiotherapy instruction.

Conditions

Shoulder Fractures

Keywords

Proximal humerus fractures; Proximal humeral fractures; Randomized controlled trial; Shoulder fractures; Non-operative treatment; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Oxford Shoulder Score (OSS)

  Patient administered shoulder specific score, score ranges between between 0 and 48, with a higher score implying a greater degree of disability.

  6 months

Secondary Outcomes (4)

• European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)

  6 months

• European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)

  12 months

• Conversion to surgery

  6 months

• Oxford Shoulder Score (OSS)

  12 months

Other Outcomes (2)

• European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L) visual analogue scale

  6 months

• European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L) visual analogue scale

  12 months

Study Arms (2)

One-time physiotherapy instruction

EXPERIMENTAL

One-time physiotherapy instruction and no usual rehabilitation care

Other: Pain management and shoulder bandage; Other: One-time physiotherapy instruction

Usual rehabilitation care

ACTIVE COMPARATOR

One-time physiotherapy instruction and usual rehabilitation care

Other: Pain management and shoulder bandage; Other: One-time physiotherapy instruction; Other: Usual rehabilitation care

Interventions

Pain management and shoulder bandage OTHER

All Patients receive standard pain management according to the local guidelines and a sling and swathe on the day of injury. After 10 to 14 days, all patients will receive a sling for optional use for one to two weeks and be randomized after oral and written informed consent.

One-time physiotherapy instruction; Usual rehabilitation care

One-time physiotherapy instruction OTHER

Patients are offered a one-time physiotherapy instruction about the course of pain and suggestions for quick and safe return to activities of daily living within the first three months post-injury.

One-time physiotherapy instruction; Usual rehabilitation care

Usual rehabilitation care OTHER

At the visit 10-14 days after the injury, the orthopaedic consultant (senior author SB) will refer the patient to usual rehabilitation care with a physiotherapist in a municipality close to the patient´s home. The physiotherapist then schedules the start date, typically three weeks after the injury. The rehabilitation content and duration is planned according to the choice of the local treating physiotherapist in consultation with the patient.

Usual rehabilitation care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 60 years or above with displaced PHFs (Neer's definition) including 2-, 3-, or 4-part fractures after a low energy trauma will be recruited.
• Prior to first visit in the outpatient clinic all patients with PHFs will be screened for eligibility based on initial radiographs and medical records by an experienced orthopaedic consultant (senior author SB) at Zealand University Hospital, Køge, Denmark. The senior author classifies fracture categories.
• Patients should be cognitively capable of answering patient-reported outcome measures.

You may not qualify if:

• Dependent on daily personal care for basic activities of daily living
• Diagnosed with dementia or institutionalized
• Does not understand written and spoken guidance in Danish
• Pathological fracture or previous fracture in the same proximal humerus
• Concomitant injury or fracture.
• Polytrauma, high-energy trauma, or multiple fractures
• Fracture dislocation or articular surface fracture
• Isolated tuberosity fracture
• Fractures not expected to heal by non-surgical treatment (no bony contact between head and shaft in both views)
• The senior author considers the patient unsuitable to attend the study for medical reasons (substance abuse, affective or psychotic disorders, apoplexy, chronic pain, malignant disease)
• Symptomatic glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff-arthropathy

Sponsors & Collaborators

• Zealand University Hospital: lead
• University of Southern Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Department of Orthopaedics, Zealand University Hospital

Køge, 4600, Denmark

Location

Related Publications (1)

• Liaghat B, Brorson S. Effect of structured rehabilitation versus non-structured rehabilitation following non-surgical management of displaced proximal humerus fractures: a protocol for a randomised clinical trial. BMJ Open. 2022 Oct 17;12(10):e064156. doi: 10.1136/bmjopen-2022-064156.

  PMID: 36253041 DERIVED

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Pain Management

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Study Officials

• Behnam Liaghat, MSc

  Zealand University Hospital, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Stig Brorson, PhD

  Zealand University Hospital, University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will not know the direction of our hypothesis. A blinded statistician will perform the primary analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 31, 2022
• Study Start: May 5, 2022
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)