CROSSFIRE - Evaluation of surgical fixation versus conservative management for distal radius fractures in the elderly.

Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: Intervention group (plate group) Surgical fixation using a volar locking plate will be performed within two weeks of initial injury according to usual care of the participating institution, with an orthopaedic surgeon in attendance. This is a commonly performed procedure and it takes about one hour. Surgical technique and type of plate (make and length) will be surgeon preference. A plaster cast may be applied post operatively but for no longer than two weeks. Active finger movement will be encouraged post operatively. Participants will be reviewed 2 weeks (10‐17 days) after surgery; the wound will be reviewed and sutures removed where necessary. Participants will be provided with a home‐exercise program (written information) post‐operatively. The home exercise programme will include four simple wrist range of motion exercises, to be performed three times daily for four weeks following the two‐week review. Referral for outpatient rehabilitation will not be routinely provided but will be permitted. CONDITION: Distal radius fractures PRIMARY OUTCOME: Patient reported wrist evaluation (PRWE) score at 12 months post treatment SECONDARY OUTCOME: Complications (deep infection, reoperation, neuropathy, tendon irritation requiring treatment, tendon rupture, fracture non‐union at minimum 6 months, implant failure, complex regional pain syndrome, death) at 3 months, 12 months, 2, 5 and 10 years. Complications will be assessed for at regular post‐surgical reviews as per usual care. Disability of the Arm Shoulder and Hand (DASH) at 12 months EQ5D (5L) (Health related quality of life) at baseline, 3 and 12 months and 2, 5 and 10 years, post treatment Pain (numerical rating scale NRS, 0‐10) at 3 and 12 months and 2, 5 and 10 years post treatment Patient rated bother with appearance (at 12 month and 2, 5 and 10 years, 5‐point Likert scale) Patient reported treatment success (at 12 months, 5‐point Likert scale) PRWE at 3 months, 2, 5 and 10 years post treatment Radiographic measures (any or all of shortening [ulnar variance], dorsal angulation [relative to radial shaft], articular step‐off) measured at presentation, post reduction, and with repeat Xray at surgical review between 6 weeks and 12 months) The participant is asked about therapy utilisation up to and at 3 months post treatment at their three‐month follow‐up INCLUSION CRITERIA: * Age 60 years or older * Displaced distal radius fracture (AO/OTA 23A or 23C with more than 10 degrees dorsal angulation, referenced off a line perpendicular to the shaft of the radius or more than 3mm shortening or more than 2mm articular step) prior to reduction * Medically fit for surgery * Independent living (including hostel accommodation) * Isolated injury * Low energy injury (fall from less than 1m) * Available for follow up for 12 months * The injury must have occurred within one week of enrolment into the study
Epistemonikos ID: 7283883993e096551017f46b94a8b6bb3afceb98
First added on: Aug 24, 2024