Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures
ConditionTibial Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentral Finland Hospital District
About this trial
The aim of this study is to compare knee function and pain one year after treatment of intra-articular proximal tibia fracture using either osteosynthesis with a locking plate (ORIF) or primary total knee replacement (TKR) in patients over 65 years of age.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute intra-articular proximal tibia fracture with impression of the joint cartilage (Schatzker grades II to VI)
Impression of tibial plateau min 2 mm
Intact patellar tendon
The patient accepts both treatment options (osteosynthesis and arthroplasty)
Disqualifiers
Not voluntary
Previous arthroplasty of the knee
Previous fracture affecting the knee joint
Inability to co-operate
Trial design
Design model
Parallel
Treatments tested in this trial
Locking plate
Procedure/SurgeryOsteosynthesis
TKR
Procedure/SurgeryTotal knee arthroplasty
Treatment groups
98 Participants
are divided into 2 treatment groupsGroup A: ORIF (open reduction-internal fixation)Active comparator 1 intervention
Group B: TKR (total knee replacement)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Knee function
Oxford knee score 12 months after randomisation
Time frame
12 monthsSecondary outcomes
1
Change in knee function
Change in Oxford knee score
Time frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years2
Change in pain
Numeric rating scale (rest, night, exercise)
Time frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years3
Change in physical performance
Short Physical Performance Battery (SPPB)
Time frame
6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years4
Change in quality of life
Short form-36 (SF-36)
Time frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 yearsOther outcomes
1
Pain medication
Pain medication used (pills per day)
Time frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years2
Complications
Any complication following injury or treatment
Time frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years3
Medical and social services (quantity)
Use of medical and social services (quantity)
Time frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years4
Medical and social services (costs)
Costs of medical and social services used
Time frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Central Finland Hospital District
Lead sponsor
Tampere University Hospital
Collaborator
Coxa, Hospital for Joint Replacement
Collaborator
Oulu University Hospital
Collaborator
Turku University Hospital
Collaborator
Kuopio University Hospital
Collaborator
Seinajoki Central Hospital
Collaborator
Paijat-Hame Hospital District
Collaborator
Source ClinicalTrials.gov