Distal Radius Fracture
Conditions
Keywords
Distal radius fracture, Rehabilitation, Patient outcomes, Physiotherapy, Occupational therapy, Orthopaedic fracture repair
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.
Interventions
OTHEREarly Strengthening Protocol
Patients 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.
Patients 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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are randomly assigned to either one of the interventional arm and will not be informed of the randomisation result. Surgeons and assessors are blinded to the intervention allocated.
Intervention model description
Double-blind randomised control trial with 50 patients in two interventional arm
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Region-specific patient reported functional outcome score | At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months | 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 | At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months | 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 | 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 | Grip strength will be measured using a dynamometer weekly for the ESP group and weekly from 6 weeks onwards for the EMP group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life Measured by SF-12 Chinese (HK) Version | At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months | 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). |
| Qualitative self-reported compliance | At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months | 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) |
| Radiographic outcomes | At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months | Subjects' X-rays will be assessed for fracture healing, implant migration, and fracture displacement. |
| Incidence of complications | At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months | Incidence of wound breakdown, infection, CRPS, implant failure including screw breakage, and re-operation |
Countries
Hong Kong
Contacts
Primary ContactChristian Prof. Fang, MBBS(HK)
Outcome results
None listed