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

NCT ID: NCT05371938

Last Updated: 2022-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-10-31

Brief Summary

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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

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Volar Locking Plate

Surgery with volar locking plate

Group Type EXPERIMENTAL

Volar locking plate

Intervention Type PROCEDURE

Volar locking plate is the intervention

External fixation

Surgery with external fixation

Group Type ACTIVE_COMPARATOR

external fixation

Intervention Type PROCEDURE

surgery with external fixation

Interventions

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Volar locking plate

Volar locking plate is the intervention

Intervention Type PROCEDURE

external fixation

surgery with external fixation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Association for Survivors of Accident and Injury

UNKNOWN

Sponsor Role collaborator

Olof Skoldenberg

OTHER

Sponsor Role lead

Responsible Party

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Olof Skoldenberg

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Ortopeadics

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Olof Sköldenberg, Professor

Role: CONTACT

0046812357245

Sara Severin, MD

Role: CONTACT

0046812356504

Facility Contacts

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Olof Sköldenberg, Professor

Role: primary

004612357245

Sara Severin, MD

Role: backup

0046812356504

Other Identifiers

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Handledsstudien 1

Identifier Type: -

Identifier Source: org_study_id

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