Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures (VIPER)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Displaced Extra-articular Distal Radius Fractures

Treatments: Other: Closed reduction and plaster; Procedure: open reduction and internal fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT02030496

NL37754.018.12

Details and patient eligibility

About

BACKGROUND:

Fractures of the distal radius are common and account for an estimated 17% of all fractures diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal radius fractures are considered to be relatively harmless, inadequate treatment may result in impaired function of the wrist. The consequences of post-traumatic loss of function are comprehensive, both on an individual and a social level, and have long been underestimated. Despite the substantial implications, no evidence-based treatment method yet exists. Good results have been described both in patients treated conservatively and surgically. Nevertheless, 60% of all fractures redislocate after conservative treatment at which point surgical reduction and fixation is the treatment of choice. Recently, the use of volar locking plates has become more popular. This type of osteosynthesis employs a volar approach to the wrist and provides immediate stable fixation of the reduced fracture. This stability allows for early mobilisation and may therefore result in an improved regain of function. The aim of this study is to compare the functional outcome following surgical reduction and fixation with a volar locking plate with the functional outcome following closed reduction and plaster immobilisation at one year follow-up in patients with displaced extra-articular distal radius fractures.

DESIGN:

This single blinded randomised controlled trial will randomise between open reduction and internal fixation with a volar locking plate (intervention group) and closed reduction followed by plaster immobilisation (control group). The study population will consist of all consecutive adult patients who are diagnosed with a displaced extra-articular distal radius fracture which has been adequately reduced at the Emergency Department. The primary outcome (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score (DASH). Since the treatment allocated involves a surgical procedure, randomisation status will not be blinded. However, the researcher assessing the outcome at one year will be unaware of the treatment allocation. In total, 90 patients will be included in this trial which will be conducted in the Academic Medical Centre Amsterdam and its partners of the regional trauma care network.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years and ≤ 75 years
• Extra-articular (AO type A) displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs by a radiologist or trauma surgeon.
• Acceptable closed reduction obtained according to current Dutch guidelines within 12 hours after presentation at the Emergency Department (ED).

Exclusion criteria

• Open distal radius fractures
• Multiple trauma patients (Injury Severity Score (ISS) ≥16)
• Other fractures of the affected extremity
• Patients with impaired wrist function prior to injury due to arthritis/neurological disorders of the upper limb
• Patient suffering from disorders of bone metabolism, connective tissue or (joint) hyperflexibility.
• Insufficient comprehension of the Dutch language to understand the treatment information and informed consent forms as judged by the attending physician.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Closed reduction and plaster

Active Comparator group

Description:

Closed reduction will be performed and after adequate reduction has been confirmed, the wrist will be immobilised according to Dutch guidelines: a splint for one week followed by a circular cast for another four weeks.

Treatment:

Other: Closed reduction and plaster

open reduction and internal fixation

Active Comparator group

Description:

The intervention group will be treated with open reduction and internal fixation with a volar locking plate.

Treatment:

Procedure: open reduction and internal fixation