knee osteoarthritis
Conditions
Interventions
'user friendly' knee joint distraction (vs. 'proof-of-concept' knee
distraction)
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with severe knee osteoarthritis (persisting conventional treatment resistant pain and cartilage tissue damage) considered for total (or uni) knee arthroplasty or high tibial osteotomy (with limited axis deviation), in general practice by the orthopaedic surgeon offered knee joint distraction as alternative treatment. In order to be eligible to participate in this study, a subject must meet all of the following criteria: - adults *65 years of age (at higher ages cost-benefit is becoming less; 15) - BMI 40/100 (conservative treatment resistant)
Exclusion criteria
Exclusion criteria: General: Patients that would not be considered for arthroplasty or osteotomy because of psychosocial condition (e.g. pain syndroms); or who meet any of the following criteria will be excluded from participation in this study: - Comorbidities that would compromise the efficacy of knee joint distraction (arbitrary defined by orthopaedic surgeons) - History of inflammatory or septic arthritis - Knee mal-alignment of more than 10 degrees - Previous surgical interventions of the index knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A: surgery time needed to place the knee joint distractor B: clinical efficacy by KOOS/WOMAC questionaire based on pain, function and stifness after 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| A: convienence/burden of wearing the device for 6-7 weeks of the knee distractor (questionnaire) B: joint space width (cartilage thickness) on radiographs after 2 years | — |
Countries
Netherlands
Outcome results
None listed