Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilisation Following Closed Reduction.

Sponsor
Cork University Hospital
Study ID
NCT05012345
Status
Unknown

Conditions

  • Distal Radius Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Below Elbow cast — PROCEDURE
    below-elbow cast ( 4 or 6 weeks )

Study Details

A single-blinded randomized controlled trial is initiated. Four weeks of plaster cast immobilization is compared with six weeks of plaster cast immobilization in adult patients with adequately reduced distal radius fracture. Primary outcome parameters are functional outcomes measured with the Patient Rated Wrist Evaluation after 6 months of follow-up (FU). Secondary outcomes are Disability of Arm, Shoulder and Hand Score after 6 months and one year, 36-Item Short-Form Health Survey after 6 months and one year, functional outcome earlier in Follow up (6 weeks, 12 weeks, 6 months, and one year), range of motion, pain level, and complications: number of re-interventions, secondary displacement, delayed and non-union.

Key Dates

Start date
Aug 20, 2021
Status verified
Aug 2021
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 4 Weeks cast immobilisation
    Patients with fracture distal radius ( indicated for conservative treatment) will stay in a below-elbow cast for 4 weeks. Following immobilisation, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised and exercises to train wrist function will be given. As extra structured advice programmes may cause no extra benefit for the patient, this was not generally prescribed. However, during FU visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected.
  • Experimental: 6 Weeks cast immobilisation
    Patients with fracture distal radius ( indicated for conservative treatment) will stay in a below-elbow cast for 6 weeks. Following immobilisation, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised and exercises to train wrist function will be given. As extra structured advice programmes may cause no extra benefit for the patient, this was not generally prescribed. However, during FU visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected.

Primary Outcome Measure

Patient Rated Wrist Evaluation (PRWE) [ Time Frame: One year ]

Central Contacts

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