No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older

PRWE

Primary outcome will be the Patient Rated Wrist Evaluation (PRWE) at 12 months. PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The questionnaire consists of two subscales (pain and function), and the score ranges from 0 (no disability) to 100 (severe disability).

Pain (NRS)

The Numeric Rating Scale (NRS) is a subjective measure of acute pain. The Numeric Rating Scale (NRS) for Pain is a validated 11-point numerical rating scale for acute and chronic pain with terminal descriptors of 0 (no pain) and 10 (worst pain possible). Patients will be asked to evaluate their perceived pain during the previous 7 days.

PASS

Patient satisfaction will be measured using the patient-acceptable symptom state (PASS). The questionnaire includes the following question: Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?

EQ-5D-5L- Quality of life

EuroQol 5-dimension 5-level health-related quality of life questionnaire (EQ-5D-5L). It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. We will use the EQ-5D-5L Index score, which is calculated based on each dimension using population-specific preference weights and will be reported on a scale from less than 0 to 1.

Serious adverse events

Serious adverse events include, but are not limited to: late surgical interventions such as corrective osteotomy or internal fixation due to symptomatic nonunion; tendon repair; carpal tunnel release; acute nerve injury confirmed by electroneuromyography; and any other adverse event that results in hospitalisation, prolongation of existing hospitalisation, is life-threatening, or leads to persistent or significant disability (for example CRPS) or incapacity. Serious adverse events will be assessed at 3- and 12-months timepoints.

Radiographic measurements

Radiographic parameters will be collected from radiographs taken at baseline and after casting. Control radiographs will be taken at the 3-month time point where the loss of reduction is measured. Radiographic measurements will include dorsal angulation (degrees), ulnar variance (mm), radial inclination (degrees), step-off in the articular surface (mm), and intra-articular gap (mm)

Tri-Axial Accelerometry (Published separately)

The upper-limb physical activity of the participants will be measured using a tri-axial (Axivity Ltd, Newcastle upon Tyne, UK) accelerometer. Activity is divided into 4 activity levels (inactive, light, moderate and vigorous), and also sleeping time is counted and recorded.

Cost-effectiveness (Published separately)

Included unit cost components include hospital stays and outpatient visits, including imaging, surgical and anesthetic procedures, physiotherapy, complication management and re-operations and cast changes. Costs will be obtained directly from patients through questionnaires administered at the 3 and 12 month follow-up, and from medical records. Cost data will be derived from the NordDRG classification system. Using the mean costs and mean health outcomes for each cohort, the incremental cost per quality-adjusted life-year (QALY) gained will be calculated.

5 year exploratory endpoint (Published separately)

PRWE, pain (NRS), quality of life, patient satisfaction (PASS), serious adverse events, and mortality will be assessed at 5 years and are exploratory endpoints.