Clinical trial NCT01904084: Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture
Official title: A Randomized, Prospective Comparison of Volar Locked Plating Versus Hoffman II Bridging External Fixation in Patients With Dislocated Distal Radius Fractures, AO/OTA Type A.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Distal radius fracture
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse-Bergen HF
First posted: 2013-07-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate function, pain and radiographic evaluation in patients treated with volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular distal radius fractures, AO/OTA type A

Detailed description: We have designed a randomized prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular dislocated distal radius fractures AO/OTA type A3. On the basis of power analysis a total of 160 patients are to be included in this project. The follow-up period is 1 year and evaluation is based on x-ray analysis, grip strength, range of motion, pain and satisfaction with the treatment ( PRWE, Quick-DASH)

Eligibility criteria: Inclusion Criteria:

* Patients with dislocated extraarticular distal radius fracture age 18-70 years

Exclusion Criteria:

* Cognitively impaired
* Drug abuse
* Congenital bone disease
* Earlier wrist injury
* Open fracture, Gustilo-Anderson type 3
* Pathological fractures( except osteoporotic fractures)
* Tourists

Primary outcomes:
measure: Patient rated wrist evaluation (PRWE)score
timeFrame: 3 months
measure: Patient rated wrist evaluation (PRWE)score
timeFrame: 6 weeks
measure: Patient rated wrist evaluation (PRWE)score
timeFrame: 12 months
Secondary outcomes:
measure: Quick-DASH score
timeFrame: 6 weeks, 3 and 12 months
measure: Pain VAS-score
timeFrame: 6 weeks, 3 and 12 months
measure: Complications
timeFrame: 6 weeks, 3 and 12 months
measure: Radiographic evaluation
timeFrame: 6 weeks and 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Orthopaedic depatment, Voss hospital
state: Voss
Study officials:
name: Trine Ludvigsen, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esposito J, Schemitsch EH, Saccone M, Sternheim A, Kuzyk PR. External fixation versus open reduction with plate fixation for distal radius fractures: a meta-analysis of randomised controlled trials. Injury. 2013 Apr;44(4):409-16. doi: 10.1016/j.injury.2012.12.003. Epub 2013 Jan 6.
citation: Ludvigsen T, Matre K, Vetti N, Kristoffersen PM, Toppe MK, Gudmundsdottir R, Krukhaug Y, Dybvik E, Fevang JM. Is there a correlation between functional results and radiographic findings in patients with distal radius fracture A0 type A3 treated with volar locking plate or external fixator? OTA Int. 2021 Aug 9;4(3):e142. doi: 10.1097/OI9.0000000000000142. eCollection 2021 Sep.