osteoarthritis
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 25
Exclusion criteria
Exclusion criteria: - Comorbidities that could interfere with the study (arbitrary defined by orthopaedic surgeons) - History of inflammatory or septic arthritis - Knee mal-alignment of more than 5 degrees - Previous severe ligament damage (including reconstructions) - Previous intra-articular fractures - Laser treatment of cartilage - Previous surgical interventions of the distracted knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint space width on standardised X-rays evaluated by knee image digital analyses (KIDA; Marijnissen A, et al, O&C 2008). Reliable hinged knee joint distraction: viz. enlarged (>3 mm as compared to no distraction) joint space width under X-ray vision under extension and flexion (0-30 degrees) during weight bearing; with smooth joint movement (0-30 degrees flexion; arbitrary to the patients satisfaction, and orthopaedic surgery*s judgement) during flexion/ extension. | — |
Secondary
| Measure | Time frame |
|---|---|
| Optimal process characteristics including motion capture, manufacturing of patient specific part, and distraction application. These parameters are arbitrary and relate to feasibility, logistics, time, etc. Only based on the first experience in the proposed feasibility study exact endpoints can be set with input of all stakeholders for future treatment studies. | — |
Countries
Netherlands
Outcome results
None listed