Osteoarthritis of the knee.
Conditions
Interventions
KJD is performed according to the methodology as used in previous knee distraction studies, using 2 monotubes, one laterally and one medially. Intra-operative the tubes are distracted 2 mm. During hos
Sponsors
Universital Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients considered for TKP according to regular clinical practice; 2. Age < 65 years; 3. Radiological joint damage: Kellgren & Lawrence score above 2; 4. Intact knee ligaments; 5. Normal range-of-motion (min. of 120° flexion; max flexion limitation of 15°); 6. Normal stability; 7. Body Mass Index < 35.
Exclusion criteria
Exclusion criteria: 1. Psychological inabilities or difficult to instruct; 2. Not able to undergo MRI examination (standard protocol); 3. Inflammatory or rheumatoid arthritis present or in history; 4. Post traumatic fibrosis due to fracture of the tibial plateau; 5. Bone-to-bone contact in the joint (absence of any joint space on X-ray); 6. Surgical treatment of the involved knee < 6 months ago; 7. An infectious susceptible prosthesis (joint replacement) in situ; 8. Primary patello-femoral OA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness determined by WOMAC at two years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical effectiveness determined by KOOS; 2. Pain evaluated with VAS score; 3. Indication of cost-effectiveness; 4. Structural repair of cartilage as determined on X-rays, MRI and biomarker analysis (only in patients treated with KJD) in comparison with own baseline values. | — |
Contacts
Public ContactK. Wiegant
Heidelberglaan 100
Outcome results
None listed