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

Olof Skoldenberg

Status: Unknown

Conditions: CRPS Type I; Osteoarthritis; Dislocation; Surgical Site Infection; Treatment Complication; Surgery; Surgery--Complications; Radius Fracture Distal; Tendon Rupture; CRPS Type II; Tendon Injuries

Treatments: Procedure: external fixation; Procedure: Volar locking plate

Study type: Interventional

Funder types: Other

Identifiers

NCT05371938

Handledsstudien 1

Details and patient eligibility

About

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.

Full description

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

Enrollment: 203 estimated patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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203 participants in 2 patient groups

Volar Locking Plate

Experimental group

Description:

Surgery with volar locking plate

Treatment:

Procedure: Volar locking plate

External fixation

Active Comparator group

Description:

Surgery with external fixation

Treatment:

Procedure: external fixation