Displaced Complete Articular Distal Radius Fractures Clinical Trial
— VIPAROfficial title:
Internal Plate Fixation vs. Plaster in Complete Articular Distal Radial Fractures
| Verified date | March 2019 |
| Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | February 14, 2019 |
| Est. primary completion date | February 14, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Academic Medical Center | Amsterdam |
| Lead Sponsor | Collaborator |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | BovenIJ Hospital, Catharina Ziekenhuis Eindhoven, Diakonessenhuis, Utrecht, Flevoziekenhuis, Groene Hart Ziekenhuis, Maasstad Hospital, Maxima Medical Center, Medical Center Alkmaar, Onze Lieve Vrouwe Gasthuis, Radboud University, Red Cross Hospital Beverwijk, Reinier de Graaf Groep, Rijnland Hospital, Westfriesgasthuis, Zaans Medical Center, Ziekenhuis Amstelland, Ziekenhuis Rivierenland |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Wrist pain and disability measured with the Patient Rated Wrist Evaluation (PRWE) | 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. | 12 months | |
| Secondary | Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (DASH) questionnaire | 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. | 6 weeks and 3, 6 and 12 months | |
| Secondary | Quality of life measured with the SF-36 | 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 and 3, 6 and 12 months | |
| Secondary | Pain measured with the Visual Analogue Scale (VAS) | 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. | 1, 3 and 6 weeks and 3, 6 and 12 months | |
| Secondary | Range of motion measured with a goniometer | 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. | 6 weeks and 3, 6 and 12 months | |
| Secondary | Grip strength measured with a dynamometer | 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 weeks and 3, 6 and 12 months | |
| Secondary | Number of patients with loss of reduction | 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. | 1, 3 and 6 weeks and 3, 6 and 12 months | |
| Secondary | Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire | Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire based on the EQ-6D and the Standard Form Health and Labour questionnaire. | 6 weeks and 3, 6 and 12 months | |
| Secondary | Number of complications in both treatment groups | 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. | 1, 3 and 6 weeks and 3, 6 and 12 months |