Displaced Extra-articular Distal Radius Fractures Clinical Trial
— VIPEROfficial title:
Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures
| Verified date | March 2018 |
| Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | May 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Academic Medical Center | Amsterdam |
| Lead Sponsor | Collaborator |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | BovenIJ Hospital, Diakonessenhuis, Utrecht, Elkerliek Hospital, Flevoziekenhuis, Groene Hart Ziekenhuis, Maasstad Hospital, Maxima Medical Center, Onze Lieve Vrouwe Gasthuis, Radboud University, Reinier de Graaf Groep, Rijnland Hospital, Westfriesgasthuis, Zaans Medisch Centrum |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Wrist function at one year assessed with PRWE score | The PRWE questionnaire 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. | 6 weeks, three, six and 12 months | |
| Secondary | Quality of Life | 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. | 6 weeks, three, six and 12 months | |
| Secondary | Pain | 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. | 6 weeks, 3, 6 and 12 months | |
| Secondary | Patient satisfaction | Patient satisfaction at one year by simply asking patients if they are satisfied with the result (yes/no). | at one year | |
| Secondary | Range of motion | Range of motion of the wrist measured on both sides with a handheld goniometer. | 6 weeks, 3, 6 and 12 months | |
| Secondary | Grip strength | Grip strength as measured with a dynamometer. | 6 weeks, 3, 6 and 12 months | |
| Secondary | Radiological parameters | 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. | At one year | |
| Secondary | Complications | 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. | 1 week, 2-3 weeks, 6 weeks, 3, 6 and 12 months |