Clinical trial NCT05371938: Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up
Official title: Longterm Follow up for Displaced Distal Radius Fracture Randomized to Surgery With Volar Locking Plate or External Fixation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radius Fracture Distal
Surgery
Surgery--Complications
Treatment Complication
Tendon Injuries
Tendon Rupture
Surgical Site Infection
CRPS Type I
CRPS Type II
Dislocation
Osteoarthritis
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: The Swedish Association for Survivors of Accident and Injury
First posted: 2022-05-12
Enrollment: 203
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Disability of the arm shoulder and hand (DASH)
timeFrame: 10 years after initial surgery
Secondary outcomes:
measure: Patient rated wrist evaluation (PRWE)
timeFrame: 10 years after initial surgery
measure: Radiological assesment
timeFrame: 10 years after initial surgery
measure: Objective tests of range of motion (ROM)
timeFrame: 10 years after initial surgery
measure: Journal investigation
timeFrame: 0-10 years after initial surgery
measure: EQ-5D
timeFrame: 10 years after initial surgery
measure: Objective test of grip strength
timeFrame: 10 year after initial surgery.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Ortopeadics
Study officials:
References: