Rehabilitation Following Displaced Proximal Humerus Fractures

Shoulder Fractures Clinical Trial

Official title:

The Effect of Rehabilitation Following Non-surgical Management of Displaced Proximal Humerus Fractures: a Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05302089
• Other study ID #: PHF_rehab
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2023
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Proximal humerus fractures (PHFs) are the closely related to osteoporosis. The lifetime risk of suffering a PHF in females aged 50 or above is 13%. About half of the fractures are minimally displaced and usually managed by short immobilization, analgetics, and early mobilization. The remaining half of the patients suffer from displaced fractures, traditionally managed surgically by open reduction and internal fixation or shoulder replacement. Within the last decades, an increasing number of high-quality randomized controlled trials (RCTs) and meta-analyses have failed to document the superiority of surgical management in displaced PHFs. Therefore, an increasing number of patients are being offered nonsurgical treatment consisting of immobilization followed by rehabilitation that may vary across countries and regions. Most elderly experience loss of function following a PHF regardless of treatment. However, optimal management and recovery of function are paramount to prevent a substantial impact on the patient's independent living and morbidity. A systematic review and metaanalysis from 2021 concluded a need for high-quality RCTs to substantiate the current evidence regarding the need for supervision after a PHF.

It is assumed that rehabilitation delivered as structured training benefits patients with PHFs, but this is not known from current evidence. It is possible that patients are even harmed with intensive training programmes. Most RCTs with a non-surgically treated group use the same exercise intervention in the two groups to best identify the difference between surgery and non-surgical treatment. Therefore, the effect of training cannot be concluded from these studies. This is supported by an expectation of more nonsurgically treated displaced PHFs due to the growing evidence of no benefit from surgery. The current study is a prerequisite for future rehabilitation studies comparing different training modalities. Therefore, this study aims is to evaluate the effectiveness of usual rehabilitation care after displaced PHF compared with one-time physiotherapy instruction.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Shoulder Fractures

Intervention

Other:
• Pain management and shoulder bandage
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
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.
• Usual rehabilitation care
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.

Locations

Country	Name	City	State
Denmark	Department of Orthopaedics, Zealand University Hospital	Køge

Sponsors (3)

Lead Sponsor	Collaborator
Zealand University Hospital	University of Copenhagen, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L) visual analogue scale	The patient's own health 'today' is rated between 0 (worst imaginable health) and 100 (best imaginable health)	6 months
Other	European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L) visual analogue scale	The patient's own health 'today' is rated between 0 (worst imaginable health) and 100 (best imaginable health)	12 months
Primary	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	European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)	Health-related quality of life, index score: < 0 to 1 (full health), with anchoring of death as 0.	6 months
Secondary	European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)	Health-related quality of life, index score: < 0 to 1 (full health), with anchoring of death as 0.	12 months
Secondary	Conversion to surgery	Number of patients converting to surgery	6 months
Secondary	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.	12 months