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Completed

NCT Number: NCT02651779

Internal Plate Fixation vs. Plaster in Complete Articular Distal Radial Fractures

There is no consensus about the best treatment for patients with displaced complete articular distal radius fractures (AO type C fractures). Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, operative treatment with plate fixation has gained popularity. The aim of this study is to compare the functional outcome of open reduction and plate fixation with closed reduction and plaster immobilisation in adult patients (18-75 years) with displaced complete articular distal radius fractures.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, Netherlands

About this study

Distal radius fractures account for 17% of all fractures diagnosed. Two third of those fractures are displaced and need to be reduced.

According to the Dutch National Guidelines, displaced distal radius fractures, after adequate reduction confirmed on X-ray, are best treated nonoperatively with cast immobilization. Moreover, the AAOS Clinical Practice Guideline only suggest surgical fixation when the articular step, after reduction, exceeds 2mm. However, both recommendations are based on studies who did not differentiate between intra- and extra-articular distal radius fractures. So, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be made. Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, a rise in use of volar plating has been observed.

The goal of open reduction and plate fixation is to restore articular congruity and axial alignment, and to enable early post-operative movement. Several studies show good radiological and functional results using the volar locking plate in unstable displaced distal radius fractures.

No studies have been carried out to assess whether operative treatment with plate fixation is superior in displaced complete articular distal radius fractures to nonoperative treatment in patients with these fracture type. Therefore, with this randomized controlled trial the investigators wish to determine the difference in functional outcome, assessed with the Patient Related Wrist Evaluation (PRWE), after open reduction and plate fixation compared to nonoperative treatment with closed reduction and cast immobilization.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients from 18 - 75 years
  • AO type C displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs/CT-scan by a radiologist or trauma surgeon
  • Acceptable closed reduction obtained immediately after admission to the Emergency Department (<12hrs)

Exclusion criteria

  • Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb
  • Open distal radius fractures
  • Multiple trauma patients (Injury Severity Score (ISS) ≥16)
  • Other fractures of the affected extremity (except from ulnar styloid process)
  • Fracture of other wrist
  • Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician
  • Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget's disease, renal osteodystrophy, osteomalacia)
  • Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfan's, Ehler Danlos or other related disorders

Treatment and study plan

Open reduction and internal plate fixation

Procedure

Other names: ORIF, Surgical treatment

Closed reduction and plasterimmobilisation

Other

Other names: Cast, Conservative treatment

Primary outcomes

  1. Wrist pain and disability measured with the Patient Rated Wrist Evaluation (PRWE)

    Time frame: 12 months

    The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of three subscales: Pain, Function and Cosmetics.

Secondary outcomes

  1. Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (DASH) questionnaire

    Time frame: 6 weeks and 3, 6 and 12 months

    The Disabilities of the Arm, Shoulder and Hand (DASH) score 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.

  2. Quality of life measured with the SF-36

    Time frame: 6 weeks and 3, 6 and 12 months

    Quality of Life assessed using the Short Form-36 (SF-36) questionnaire. The SF-36 is a validated multipurpose, short form health survey which contains 36 questions representing eight different health domains. These domains are combined into a mental and physical component scale. From each domain, scores ranging from 0 to 100 points are derived, with lower scores indicating poorer quality of life.

  3. Pain measured with the Visual Analogue Scale (VAS)

    Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months

    Pain as indicated on a visual Analogue Scale (VAS), in which 0 implies no pain and 10 the worst possible pain. Patients will be asked to give an estimation of the type and quantity of pain medication taken during all follow-up visits.

  4. Range of motion measured with a goniometer

    Time frame: 6 weeks and 3, 6 and 12 months

    Range of motion of the wrist measured on both sides with a handheld goniometer in degrees. ROM includes pronation and supination, ulnar and radial deviation and palmar and dorsal flexion of the wrist.

  5. Grip strength measured with a dynamometer

    Time frame: 6 weeks and 3, 6 and 12 months

    Grip strength as measured with a dynamometer in kg as the mean of three measurements. Grip strength will be measured as a percentage of the uninjured side.

  6. Number of patients with loss of reduction

    Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months

    Radiographs will be performed to ensure that loss of reduction has not occurred. Loss of reduction is defined as <15° radial inclination, >15° of dorsal angulation or >20° of volar angulation, >3 mm shortening of ulnar variance or >2 mm of articular step-off or gap. Radial inclination, volar/dorsal tilt, ulnar variance and radial length will be measured digitally in the Picture Archiving and Communication System (PACS) on standard posterior anterior (PA), lateral carporadial and lateral X-rays of the wrist. If loss of reduction occured, operative treatment will be considered, but will be at discretion of the treating surgeon.

  7. Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire

    Time frame: 6 weeks and 3, 6 and 12 months

    Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire based on the EQ-6D and the Standard Form Health and Labour questionnaire.

  8. Number of complications in both treatment groups

    Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months

    Number of complications in both patients treated with plasterimmobilisation and ORIF. Complications include loss of reduction, cross-overs from conservative to operative treatment, fracture malunion or non-union, wound and/or plate infection, tendon irritation and/or rupture, neuropathy and the occurrence of complex regional pain syndrome.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • BovenIJ Hospital
  • Catharina Ziekenhuis Eindhoven
  • Diakonessenhuis, Utrecht
  • Dijklander Ziekenhuis
  • Flevoziekenhuis
  • Groene Hart Ziekenhuis
  • Maasstad Hospital
  • Maxima Medical Center
  • Medical Center Alkmaar
  • Onze Lieve Vrouwe Gasthuis
  • Radboud University Medical Center
  • Red Cross Hospital Beverwijk
  • Reinier de Graaf Groep
  • Rijnland Hospital
  • Zaans Medical Center
  • Ziekenhuis Amstelland
  • Ziekenhuis Rivierenland

Registry information

Acronym: VIPAR

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2016
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.