Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up

N/AUnknownNCT05371938

Olof Skoldenberg203 enrolled

Overview

A 10-year follow up of a fusion of two earlier published randomized controlled trials. 203 patients with displaced distal radius fractures were randomized to surgery with a volar locking plate or external fixation.

Follow up includes PROMs (DASH, PRWE, EQ-5D), radiological assesment and objective tests by a hand occupational therapist (ROM, grip strength). Previous Clinical trials registration for the original studies this long-term follow up is a continuation on: NCT00989222, NCT01034943, NCT01035359

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

203

Conditions

Radius Fracture Distal Surgery Surgery--Complications Treatment Complication Tendon Injuries

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: DS center * acute unilateral dorsally displaced distal radius fracture with a axial shortening of at least 4 mm or a dorsal displacement of at least 20 degrees. * Age 20-70 SÖS center * Age 50-74 for women and 60-74 for men * injury only after fall from a standing height * wrist radiography of at least 20 degrees dorsal dislocation and/or at least 5 mm axial shortening * good knowledge of written and spoken swedish * fracture diagnosed within 72 hours from injury * patient resident within the catchment area of SÖS center Exclusion Criteria: DS center: * no previous fracture of either wrist * ipsilateral acute fracture of the upper extremity * medicated with warfarin * unable to cooperate with follow-up (dementia, substance abuse, psychiatric illness, language problems) * open fracture * fracture that was not amenable by both methods (distal fragment to small or to comminuted) SÖS center: * former disability of either wrist * other concomitant injuries * rheumatoid arthritis or other severe joint disorder * Dementia or pfeiffer score under 5 points * drug abuse, alcohol abuse or psychiatric disorder * dependency in activity of daily living * medical condition contradicting general anesthesia

Outcomes

Primary Outcomes

Disability of the arm shoulder and hand (DASH)

PROM Patient Rated outcome Measurement. A 30-item questionnaire to assess musculoskeletal disorders in upper limbs. It also has two 4-items optional modules to assess function and symptoms in athletes, artists and workers. Item response range from 1 (no difficult) to 5 (unable). The total score ranges from 0 (no disability) to 100 (most severe disability).