Clinical trial NCT03716661: Operative vs. Conservative Treatment of Distal Radius Fractures
Official title: Operative vs. Conservative Treatment of Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Distal Fracture
Distal Radius Fracture
Radius Fracture Distal
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. The Danish Health and Medicines Authority recommend that broken wrists are treated with surgery by using plates and screws when certain radiological criteria are met. Recent studies show that, apparently, there are no advantages by operating rather than treating with plaster when comparing the functional results after one year. However, there is a 30 % risk of serious complications occurring after surgery. This study will examine the pros and cons that participants at 65+ years with broken wrists experience after, by lot, having been treated with either surgery (using plates and screws) or without surgery (using plaster for 5 weeks). The purpose of this study is to compare the complications and level of functioning between participants treated with surgery and without surgery.


Eligibility criteria: Inclusion Criteria:

* Danish National Guidelines for operative treatment of distal radius fractures

Exclusion Criteria:

* Patients treated with plaster in Arm1/control group who unexpectedly requires surgery

Primary outcomes:
measure: Number of participants with treatment-related complications at baseline
timeFrame: Baseline
measure: Change in number of participants with treatment-related complications from baseline at week 2
timeFrame: Week 2
measure: Change in number of participants with treatment-related complications from baseline at week 5
timeFrame: Week 5
measure: Change in number of participants with treatment-related complications from baseline at month 6
timeFrame: Month 6
measure: Change in number of participants with treatment-related complications from baseline at 1 year
timeFrame: 1 Year
measure: Range of motion of the wrist at week 5
timeFrame: Week 5
measure: Change in range of motion of the wrist from week 5 at month 6
timeFrame: Month 6
measure: Change in range of motion of the wrist from month 6 at 1 year
timeFrame: 1 Year
measure: Level of functioning at baseline
timeFrame: Baseline
measure: Change in level of functioning from baseline at week 2
timeFrame: Week 2
measure: Change in level of functioning from baseline at week 5
timeFrame: Week 5
measure: Change in level of functioning from baseline at month 6
timeFrame: Month 6
measure: Change in level of functioning from baseline at 1 year
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Regionshospitalet Randers
Study officials:
References:
citation: Pedersen J, Mortensen SO, Rolfing JD, Thorninger R. A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65 years. BMC Musculoskelet Disord. 2019 Jun 29;20(1):309. doi: 10.1186/s12891-019-2677-y.