About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Early Strengthening Protocol
Other interventionPatients in the ESP intervention arm will undergo active and passive exercises as well as strengthening exercises after their initial assessment by rehabilitation therapists within 2 weeks of their discharge. Early use of strength and passive stretching will be encouraged immediately after allocation.
Early Motion Protocol
Other interventionPatients are instructed for active flexion, extension, supination, pronation and finger flexion of the operated wrist along with motion of the shoulder and elbow after operation. Active mobilization is continued for the initial post-operative 6 weeks with allied health therapists. Passive mobilization and strengthening is started at the post-operative 8-10-week period.
Treatment groups
Trial outcomes
Primary outcomes
Region-specific patient reported functional outcome score
Physical function and symptoms measured by Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), an 11-item patient-reported measure with a total score ranging from 0 (no disability) to 100 (most severe disability).
Range of motion
Subjects' wrist range of motion, including: pronation, supination, flexion, and extension will be measured by allied health therapists at each follow-up timepoint.
Grip strength
Grip strength will be measured using a dynamometer weekly for the ESP group and weekly from 6 weeks onwards for the EMP group.
Secondary outcomes
Health-related Quality of Life Measured by SF-12 Chinese (HK) Version
12-item Short Form Health Survey (SF-12), a patient-reported outcome measure of HRQOL comprised of a mental component (MCS) and physical component (PCS), each with a final score ranging from 0 (worst outcome) to 100 (best outcome).
Radiographic outcomes
Subjects' X-rays will be assessed for fracture healing, implant migration, and fracture displacement.
Incidence of complications
Incidence of wound breakdown, infection, CRPS, implant failure including screw breakage, and re-operation
Qualitative self-reported compliance
Subjects' self-reported score on their compliance to the rehabilitation exercises based on a Likert Scale of 1 (Did not follow) to 5 (Fully comply)
Sponsors and contacts
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