Clinical trial NCT04716309: Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).
Official title: Unstable Distal Radius Fractures AO-type A2, A3 and C1 With Dorsal Dislocation in Patients Aged 18-64 Years. Open Reduction and Volar Locking Plate Versus Closed Reduction and Percutaenous Pinning. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Distal Radius Fractures
Wrist Fracture
Colles' Fracture
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sophies Minde Ortopedi
First posted: 2021-01-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). The hypotheses is that CRPP will give equal function and satisfaction to VLP. Patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. These follow-ups will be performed by hand therapist. Scores are also recorded from Patient-Reported Wrist and Hand Evaluation (PRWHE), Quick-Dash (Q-d) and EuroQol Questionnaire (EQ-5D) questionnaires. The main efficacy measure in the study is PRWHE scores after 12 months. There will be X-ray initially, postoperatively and after 12 months. Sub-objectives in the study are analyses of cost-effectiveness (measured by EQ 5D, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.


Eligibility criteria: Inclusion Criteria:

* distal radius fractures of AO- A2, A3 and C1 which should be operated on in accordance with Norwegian guidelines
* \>18 years and \<65 years
* address in Oslo municipality

Exclusion Criteria:

* multitrauma
* previous fracture same wrist
* multiple injuries on the same side
* not competent to consent
* dementia / nursing home patient
* substance abuse
* foreign / tourists
* median nerve compression requiring emergency surgery
* pathological fracture
* open fracture
* congenital malformations that make it difficult to interpret data
* patient does not want surgical treatment
* not operable due to comorbidity (ASA 4, some ASA 3 after assessment by anesthesiologist)
* more than 10 days after injury

Primary outcomes:
measure: Patient-Related Wrist and Hand Evaluation (PRWHE) score
timeFrame: 1 year
Secondary outcomes:
measure: Quick Dash score
timeFrame: 1 year
measure: X-ray wrist posterior-anterior and lateral view
timeFrame: 1 year
measure: Range of motion
timeFrame: 1 year
measure: Grip strength
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Skadelegevakten
Study officials:
affiliation: Oslo University Hospital
name: John Williksen, MD
role: STUDY_DIRECTOR
References: