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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Current Primary Outcome: Wrist function/pain/disability at one year assessed with DASH score and PRWE score [ Time Frame: At12 months follow up ]

the primary endpoint of this study is wrist function, pain and disability as measured with the DASH score and Patient Rated Wrist Evaluation score (PRWE). 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. 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of Life [ Time Frame: 6 weeks, three, six 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.
  • Pain [ Time Frame: 6 weeks, 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.
  • Patient satisfaction [ Time Frame: at one year ]
    Patient satisfaction at one year by simply asking patients if they are satisfied with the result (yes/no).
  • Range of motion [ Time Frame: 6 weeks, 3, 6 and 12 months ]
    Range of motion of the wrist measured on both sides with a handheld goniometer.
  • Grip strength [ Time Frame: 6 weeks, 3, 6 and 12 months ]
    Grip strength as measured with a dynamometer.
  • Radiological parameters [ Time Frame: At one year ]
    Radiological parameters: radial inclination, volar/dorsal tilt, comminution, ulnar variance and radial length measured digitally in the Picture Archiving and Communication System (PACS) on standard posterior anterior (PA), lateral carporadial and lateral X-rays of the wrist. Radiographs will be obtained according to standardised procedures. PA radiographs with the shoulder in 90 degrees abduction, elbow in 90 degrees flexion and the wrist in neutral position; lateral X-rays with the shoulder in neutral position and elbow in 90 degrees flexion; and the lateral carporadial radiographs will be obtained by positioning the lower arm on a 20-25 degrees angled wedge.
  • Complications [ Time Frame: 1 week, 2-3 weeks, 6 weeks, 3, 6 and 12 months ]
    Complication rate such as: 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.


Original Secondary Outcome: Same as current

Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dates:
Date Received: January 6, 2014
Date Started: January 2013
Date Completion:
Last Updated: May 12, 2017
Last Verified: May 2017