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

Not Applicable

• Conditions: Tendon Injuries; CRPS Type I; CRPS Type II; Surgery; Treatment Complication; Osteoarthritis; Radius Fracture Distal; Tendon Rupture; Dislocation; Surgery--Complications
• Interventions: Procedure: Volar locking plate; Procedure: external fixation

• Registration Number: NCT05371938
• Lead Sponsor: Olof Skoldenberg

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

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-01
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-10
• Last Update Submitted: 2022-05-10
• Study First Posted: 2022-05-12
• Last Update Posted: 2022-05-12
• Primary Completion: 2023-04
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volar Locking Plate	Volar locking plate	Surgery with volar locking plate
External fixation	external fixation	Surgery with external fixation

Primary Outcome Measures

Name	Time	Method
Disability of the arm shoulder and hand (DASH)	10 years after initial surgery	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).

Secondary Outcome Measures

Name	Time	Method
Radiological assesment	10 years after initial surgery	x-ray of both wrists, AP and lateral. Assessing radial inclination, dorsal tilt, ulnar variance. Osteoarthritis of the radioulnar joint and DRU-joint, fractures in carpus/ulna. VISI/DISI and SL-dissociation.
Objective tests of range of motion (ROM)	10 years after initial surgery	pronation and supination, ulnar- and radial deviation, volar flexion and doral extension of both wrists with a goniometer, units will be degrees.
Patient rated wrist evaluation (PRWE)	10 years after initial surgery	A patient rated outcome measurement(PROM) a subjective test of function by a 15-item questionnaire. PRWE is specific for wrist evaluation. It consists of two subscales - pain and function. Total score ranges from 0 (no disability) to 100 (severe disability)
Journal investigation	0-10 years after initial surgery	A journal assesment to find complications as infections, reoperations, CRPS, nerv injuries.
EQ-5D	10 years after initial surgery	A health related quality of life questionnaire. EQ-5D is the correct name and not an abbreviation. 5 dimensions of health is assessed (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) in three levels (no problems/some or moderate problems/extreme problems). The responses of EQ-5D can be converted to a singel number - a index value and compared with a value set. The index value reflects how good or bad the health statues is. There is also a visual analogue scale on overall health with the scale 0 (worst imaginable health state) to 100 (best imaginable health state).
Objective test of grip strength	10 year after initial surgery.	Test of grip strength by GRIPPIT units is Newton. Grip strength will be measured bilateral and presented as maximum, mean and value after 10 seconds.

Trial Locations

Locations (1)

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Ortopeadics; 🇸🇪 Stockholm, Sweden