A randomised controlled trial investigating the effect of duration of immobilisation on function and pain following open reduction and internal fixation (ORIF) for adult distal radius fractures managed with a locked volar plate.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: Immobilisation periods of one and three weeks for acute distal radius fracture following locked volar plate fixation. This investigation involves three separate treatment groups that differ in the periods of immobilisation for participants following surgery. The treatment groups are one, three and six weeks of immobilisation. All participants will receive the same treatment for the first week following surgery. Overlying the post‐operative dressing, a below elbow volar splint will be applied immediately following ORIF. This will remain insitu for seven days following surgery during which time participants will be encouraged to perform light functional activities and active finger, thumb, elbow and shoulder range of motion exercises on the injured side. The first post‐operative review with the orthopaedic surgeon and treating physiotherapist will be scheduled for all participants seven days following surgery. At this review, all participants will receive standard advice about wound care, swelling control, fracture protection and activity levels. Participants will have different treatment protocols depending on group allocation. The one week immobilisation group will have their splint removed while the three and six week immobilisation groups will have a full below elbow plaster applied which will remain in place for two and five weeks respectively. Following removal of the splint in one week immobilisation group and the plaster cast in the three and six weeks immobilisation groups, all participants will receive a standardised six week program of physiotherapy. Standardised physiotherapy treatment will be provided by physiotherapists working in the outpatient departments of Western Health. All treatments will be provided by one of four physiotherapists specifically trained on the treatment principles applied in this investigation. Training sessions will be given by the principal investigator to each of the four treating physiotherapists on the standardised assessment and support of participants enrolled in this investigation. Treatment will be commenced within three days of splint/cast removal. The nature of this investigation makes it impossible to blind the physiotherapists providing care to treatment group. After removal of the splint/cast, participants from each treatment group will follow a standardised exercise protocol weekly for a period of six weeks. Therefore, the exercise protocol will be given to participants in the one week immobilisation group from the beginning of week two to the end of week seven, participants in the three week immobilisation group from the beginning of week four to the end of week nine and the six week immobilisation group from the beginning of week seven to the end of week 12. All participants will attend an individual appointment with one of the four study physiotherapists. At this appointment, and the six subsequent weekly appointments, the following eight areas will be addressed: 1. Information on surgery, prognosis, expectations 2. Patient‐Specific Functional Scale (PSFS) 3. Recording of wrist and forearm active range of motion, grip strength and pain on VAS 4. Discussion and therapist demonstration of weekly exercises from standardised exercise program 5. Participant demonstration of weekly exercises from standardised exercise program 6. Training diary 7. Complications following surgery 8. Participant questions CONDITION: Distal radius fracture managed with open reduction and internal fixation involving locked volar plate PRIMARY OUTCOME: Mean score on Patient Rated Wrist Evaluation Mean score on Visual Analogue Scale (VAS) for 'worst' and 'usual' pain over past week. ; ; How would you describe your completion of your home exercises over the past week? SECONDARY OUTCOME: Compliance with home exercise program. This measurement will be based on the participant's weekly entries in their training diary and by the assessor asking the following question at each assessment: ; ‐Did not complete any exercises in the past week ; ‐Completed exercises on some days in the past week ; ‐Completed exercises on most days in the past week ; ‐Completed exercises on all days in the past week Mean Disabilities of the Arm, Shoulder and Hand (DASH) score Mean grip strength measure Mean Patient Specific Functional Scale (PSFS) score Mean wrist and forearm active range of motion measures Number of 'adverse events' ; ; Screening for adverse events/complications will occur during the clinical examination by the orthopaedic team at the review one week following surgery and during the six weeks of physiotherapy treatment following removal of the immobilisation. For this investigation, adverse events include any of the following: ; ; ‐Neuropathy ; ‐Carpal tunnel syndrome ; ‐Tendinopathy or tendon rupture ; ‐Wound infection ; ‐Fixation position loss ; ; Members of the orthopaedic team will be advised to discuss any adverse events/complications detected at the one week review appointment that could impact on appropriateness for the participant's allocation to immobilisation groups with the treating physiotherapist. Any adverse events/complications identified by a member of the orthopaedic team or treating physiotherapist will be documented by the treating physiotherapist. Discussions between an orthopaedic surgeon, the treating physiotherapist +/‐ the principal investigator will determine if the adverse event/complication is significant enough for the participant to be removed from the investigation. All attempts will be made for the immobilisation time and physiotherapy management to remain unchanged from the original allocation. Participants who experience or are at risk of experiencing an adverse event/complication will be closely monitored by the treating physiotherapist. INCLUSION CRITERIA: 1. Fracture involving the distal radius (within 3cm of the distal end of the radius) with or without an associated ulna fracture 2. Operative management involving a locked volar plate for distal radius fracture 3. 18 years or more
Epistemonikos ID: 2648b9856896f3097e2b7c0a3684ba8cda571c4f
First added on: Aug 22, 2024