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

NCT02030496 | Completed

• 1 other identifier: NL37754.018.12
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Displaced Extra-articular Distal Radius Fractures

Keywords

distal radius fractures; Closed reduction; Open reduction internal fixation; Volar plate; Redislocation; Unstable fracture; Extra-articular fracture; Colles fracture; Barton fracture

Outcome Measures

Primary Outcomes (1)

• Wrist function/pain/disability at one year assessed with DASH score

  the primary endpoint of this study is wrist function, pain and disability as measured with the DASH score. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.

  At12 months follow up

Secondary Outcomes (8)

• Wrist function at one year assessed with PRWE score

  6 weeks, three, six and 12 months

• Quality of Life

  6 weeks, three, six and 12 months

• Pain

  6 weeks, 3, 6 and 12 months

• Patient satisfaction

  at one year

• Range of motion

  6 weeks, 3, 6 and 12 months

Study Arms (2)

Closed reduction and plaster

ACTIVE COMPARATOR

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.

Other: Closed reduction and plaster

open reduction and internal fixation

ACTIVE COMPARATOR

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

Procedure: open reduction and internal fixation

Interventions

open reduction and internal fixation PROCEDURE

The surgery will be performed by a certified trauma surgeon. After the fracture site is exposed, the fracture will be reduced and provisionally fixed with K-Wires and reduction forceps. An appropriate volar locking plate which best suits the anatomy of the wrist and the fracture type will be selected. Screw placement and fracture reduction will be confirmed intra-operatively by radiographic images. No post-operative fixation will be applied and patients will be instructed to use the affected extremity in daily activities as pain allows. According to Dutch treatment standards, vitamin C 500 milligrams will be prescribed to all patients at initial presentation and for a duration of two months in order to prevent Complex Regional Pain Syndrome.

open reduction and internal fixation

Closed reduction and plaster OTHER

Closed reduction will be performed according to the Robert-Jones method. This involves increasing the deformity first, then applying continuous traction and immobilising wrist and hand in the reduced position. Additional radiographs will be performed to verify the quality of the reduction. After this 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. According to Dutch treatment standards, vitamin C 500 milligrams will be prescribed to all patients at initial presentation and for a duration of two months in order to prevent Complex Regional Pain Syndrome.

Closed reduction and plaster

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Onze Lieve Vrouwe Gasthuis: collaborator
• Diakonessenhuis, Utrecht: collaborator
• Elkerliek Hospital: collaborator
• Groene Hart Ziekenhuis: collaborator
• Dijklander Ziekenhuis: collaborator
• Reinier de Graaf Groep: collaborator
• Maasstad Hospital: collaborator
• BovenIJ Hospital: collaborator
• Rijnland Hospital: collaborator
• Flevoziekenhuis: collaborator
• Radboud University Medical Center: collaborator
• Maxima Medical Center: collaborator
• Zaans Medisch Centrum: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Wrist Fractures; Colles' Fracture

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Radius Fractures

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• J. Carel Goslings, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: January 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

NL (1)