Clinical trial NCT06931418: Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius
Official title: Randomized Controlled Trial for Post-operative Fracture Distal Radius Rehabilitation - The Early Motion Protocol Rehabilitation vs. Early Strengthening Study (EMPRESS Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Distal radius fracture
Rehabilitation
Patient outcomes
Physiotherapy
Occupational therapy
Orthopaedic fracture repair
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomised control trial with 50 patients in two interventional arm
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to demonstrate safety and efficacy of an early strengthening and passive mobilization rehabilitation program for post-operative distal radius fracture fixation surgery compared to current conventional rehabilitation.

Detailed description: Functional outcome after distal radius fracture fixation has often been variable with multiple factors affecting final results. Early mobilization rehabilitation protocols have been the gold standard after fracture fixation surgery. Rehabilitation protocols vary from center to center's own practices. However, these commonly encompass an early mobilization protocol or otherwise known as accelerated rehabilitation or enhanced recovery after surgery (ERAS) programs. Such programs comprise of a short duration of immobilization followed by a period of active mobilization before strengthening exercises are employed.

The investigators have performed early motion protocol (EMP) rehabilitation in the last decade in the investigation center for post-operative fracture distal radius fixation patients. The early motion protocol allows immediate active mobilization without a period of immobilization or splint protection. Despite early mobilization rehabilitation, there are a subset of patients who develop significant stiffness and pain with poor functional outcomes, especially in the early post-operative period. Moreover, some patients may also develop complex regional pain syndrome (CRPS) albeit early active mobilization. Thus, an early strengthening protocol (ESP) was developed to allow for immediate strengthening and passive mobilization exercises post-operatively with physiotherapist and occupational therapist guidance. Herein this study, the investigators hope to demonstrate the safety and efficacy of an ESP rehabilitation compared to EMP for post-operative distal radius fracture fixation.

Eligibility criteria: Inclusion Criteria:

* Aged 50 years or older
* Diagnosed with an isolated closed injury, displaced, distal radius fracture (AO/OTA Classification 23-A1-3, B1-2, C1-2) without articular comminution
* Requires operative fixation
* Able to give consent

Exclusion Criteria:

* History of previous hand or wrist surgery
* Neurological injury or pre-existing neurological conditions to the upper limb
* Underlying osteoarthritis of the wrist
* Unfit for surgical anesthesia
* Subacute fractures with delayed presentation (\>2 weeks since initial injury)
* Unable to consent
* Refuse surgical intervention
* Unable to follow commands for rehabilitation
* Fixation construct or injuries requiring immobilization after surgery, such as unfixed distal ulna head or shaft fractures that require splintage or distal radio-ulnar joint instability planned for immobilization

Primary outcomes:
measure: Region-specific patient reported functional outcome score
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
measure: Range of motion
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
measure: Grip strength
timeFrame: ESP group: At post-op weekly from 1 to 12 weeks, 6 months and 12 months ; EMP group: At post-op weekly from 6 to 12 weeks, 6 months and 12 months
Secondary outcomes:
measure: Health-related Quality of Life Measured by SF-12 Chinese (HK) Version
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
measure: Radiographic outcomes
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
measure: Incidence of complications
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
measure: Qualitative self-reported compliance
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
Study officials:
affiliation: Dept of Orthopaedics and Traumatology, Queen Mary Hospital
name: Christian Prof. Fang, MBBS(HK), FRCS(Edinburgh), FHK
role: PRINCIPAL_INVESTIGATOR
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