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

NCT05371938 | Unknown

• 1 other identifier: Handledsstudien 1
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  10 years after initial surgery

Secondary Outcomes (6)

• Patient rated wrist evaluation (PRWE)

  10 years after initial surgery

• Radiological assesment

  10 years after initial surgery

• Objective tests of range of motion (ROM)

  10 years after initial surgery

• Journal investigation

  0-10 years after initial surgery

• EQ-5D

  10 years after initial surgery

Study Arms (2)

Volar Locking Plate

EXPERIMENTAL

Surgery with volar locking plate

Procedure: Volar locking plate

External fixation

ACTIVE COMPARATOR

Surgery with external fixation

Procedure: external fixation

Interventions

Volar locking plate PROCEDURE

Volar locking plate is the intervention

Volar Locking Plate

external fixation PROCEDURE

surgery with external fixation

External fixation

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olof Skoldenberg: lead
• The Swedish Association for Survivors of Accident and Injury: collaborator

Study Sites (1)

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

Stockholm, 182 88, Sweden

RECRUITING

MeSH Terms

Conditions

Wrist Fractures; Tendon Injuries; Surgical Wound Infection; Reflex Sympathetic Dystrophy; Causalgia; Joint Dislocations; Osteoarthritis

Interventions

External Fixators

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Complex Regional Pain Syndromes; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neuralgia; Joint Diseases; Musculoskeletal Diseases; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Central Study Contacts

Olof Sköldenberg, Professor

CONTACT

0046812357245; olof.skoldenberg@regionstockholm.se

Sara Severin, MD

CONTACT

0046812356504; sara.l.severin@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: May 12, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)