arthrosis, osteoarthritis osteoarthritis
Conditions
Interventions
KP is indicated and surgically implanted according to regular clinical practice
(can be a total- or unicompartmental KP, in line with local practice in
consultation with the patient and conform loca
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of knee OA - Age <= 65 years and >= 18 years - Persistent, refractory pain, insufficiently responding to conservative and previous non-surgical therapy - Structural OA joint damage, indicated by a K&L grade of at least 2 - Able to wear an external fixator and care for it for 6 weeks - Accepting that the maximal effect of KJD is not present directly after removal of the frame but may take months after frame removal - Sufficient joint stability (according to the orthopedic surgeon's judgement) - Flexion (>100 degrees) and extension range (<10 degrees) - Weight and BMI <120 kg and <35 kg/m2 respectively
Exclusion criteria
Exclusion criteria: - Primary patella-femoral knee osteoarthritis - Surgical intervention in last 6 months - Leg-axis deviation > 10 degrees - Serious osteopenia making placing bone-pins and wearing a frame into a risk (according to the orthopedic surgeon's judgement) - Coagulation problems making occurrence of thrombosis or embolies into a risk (according to the orthopedic surgeon's judgement) - Existing endoprosthesis at hip or ankle of the ipsilateral side to prevent infection of existing prosthesis. Whether an endoprosthesis at any other joint is a reason to exclude the patient is according to the orthopedic surgeon's judgment. - History or presence of joint infection/inflammation - Hypersensitivity to antibiotics - Presence of systemic inflammatory disease, like rheumatoid arthritis For the GODIVA bone substudy: Inability to undergo a knee-MRI and knee-CT according to the local enforced criteria in regular health care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Western Ontario and McMaster Universities Arthritis Index (WOMAC) total score. For the substudy: MRI, CT image markers and blood and urine biochemical markers | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary outcomes: WOMAC/KOOS Pain, stiffness, and physical function sub-scores, quality of life (EQ-5D, SF-36), radiographic joint space width (KJD only); adverse events, and productivity and healthcare cost. All assessed over 24 months. | — |
Countries
Netherlands
Contacts
Public ContactP.M.J. Welsing
Universitair Medisch Centrum Utrecht
Outcome results
None listed