The With Or Without Olecranon K-wires Trial
ConditionOlecranon Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
Fractures of the elbow tip (olecranon) that leave the elbow joint stable but where the fracture ends are separated (Mayo type 2a and 2b) can be treated with pins and a metal wire (tension band wiring, TBW) or metal wiring alone (cerclage fixation, CF ). Previous studies have reported high re-operation and complication rates following TBW. The current study's hypothesis, based on two retrospective studies, is that CF of these fractures yield lower re-operation rates compared with TBW. The investigators also hypothesize that the overall complication rate will be lower following CF. The aim is to investigate this hypothesis in a randomized controlled trial. Patients that are 18 years or older with Mayo type 2a and 2b olecranon fractures at Skåne University hospital will be invited to the study. Participation is voluntary. Patients who accept participation will be randomly assigned to surgery by either TBW or cerclage fixation. Two hundred participants will be followed by physiotherapists for 36 months post-surgery assessing re-operations, complications, patient reported outcome, and elbow function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sustained Olecranon type fracture of Mayo 2a or 2b
Seeking healthcare in at the Skåne University Hospital in Lund and Malmö, Sweden.
Disqualifiers
Subjects unable to participate in follow up (for example subjects with active substance abuse, dementia, inability to communicate or understand the questionnaires or subjects living in other administrative healthcare regions).
Subjects unable to give informed written consent.
Subject where non operative treatment is indicated due to frailty or severe ongoing disease.
Fracture not operated within 14 days from the date the fracture was sustained.
Trial design
Design model
Parallel
Treatments tested in this trial
Cerclage fixation
Procedure/SurgeryThe intervention is by surgical open reduction and internal fixation of the fracture using two 1.0mm cerclage.
Tension band wiring
Procedure/SurgeryThe intervention is by surgical open reduction and internal fixation of the fracture using a 1.0mm cerclage and two 1.6 mm k-wires as described in AO-guidelines.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: CerclageActive comparator 1 intervention
Group B: Tension Band WiringActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Re-operation rate 1.5 months.
Total re-operation rate of the operated elbow regardless of cause.
Time frame
Recorded at 1.5 months after intervention.2
Re-operation rate 3 months.
Total re-operation rate of the operated elbow regardless of cause.
Time frame
Recorded at 3 months after intervention.3
Re-operation rate 12 months.
Total re-operation rate of the operated elbow regardless of cause.
Time frame
Recorded at 12 months after intervention.4
Re-operation rate 36 months.
Total re-operation rate of the operated elbow regardless of cause.
Time frame
Recorded at 36 months after intervention.Secondary outcomes
1
Complication rate 1.5 months.
Total complication rate.
Time frame
Recorded at 1.5 months after intervention.2
Complication rate 3 months.
Total complication rate.
Time frame
Recorded at 3 months after intervention.3
Complication rate 12 months.
Total complication rate.
Time frame
Recorded at 12 months after intervention.4
Complication rate 36 months.
Total complication rate.
Time frame
Recorded at 36 months after intervention.Other outcomes
1
Grip strength 0.5 months.
Grips strength will be evaluated using a JAMAR dynamometer as detailed in the Swedish National Quality Register for Hand Surgery (HAKIR)
Time frame
Recorded at 0.5 months after intervention.2
Grip strength 1.5 months.
Grips strength will be evaluated using a JAMAR dynamometer as detailed in the Swedish National Quality Register for Hand Surgery (HAKIR)
Time frame
Recorded at 1.5 months after intervention.3
Grip strength 3 months.
Grips strength will be evaluated using a JAMAR dynamometer as detailed in the Swedish National Quality Register for Hand Surgery (HAKIR)
Time frame
Recorded at 3 months after intervention.4
Grip strength 12 months.
Grips strength will be evaluated using a JAMAR dynamometer as detailed in the Swedish National Quality Register for Hand Surgery (HAKIR)
Time frame
Recorded at 12 months after intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Skane
Lead sponsor
Lund University
Collaborator
Source ClinicalTrials.gov