knee stability
Conditions
Interventions
Patients who are included in study will receive a total knee replacement which
they were about to receive anyway. Standard surgical procedure and rehab
programme will be followed which is not influe
kneelax
stability
Sponsors
Antonius Ziekenhuis, Sneek
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Patients requiring a knee replacement as determined jointly by the surgeon and the patient * Over 18 years of age at time of surgery * Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up. * Patients who are capable of, and have given, informed consent to their participation in the study
Exclusion criteria
Exclusion criteria: * Patients lacking capacity to or who will not provide consent * Severe muscular, neurological or vascular deficiencies which compromise the affected extremity * Bone deficiency or deficient bone quality likely to compromise the implant (as determined by surgical team on pre-operative radiographs) * Severe ligament instability * Hypersensitivity to the materials used * Alcoholism or other addictive disorders * Sepsis * Osteomyelitis * Osteomalacia * Severe Osteoporosis * clinical judgement * Metabolic disorders which may impair bone formation * Non correctable flexion contractures >20 degrees * Varus/valgus deformities >15 degrees * Those whose prospects for a recovery to independent mobility would be compromised by known pre-existing medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint: Measurement with Kneelax device will provide comparison in anterior/posterior displacement (laxity) of the replaced joint at 30, 60 and 90 degrees angle. With these measurements the three prosthesis will be compared. This measurement will take place once: 12 months post-op. Kneelax is a validated device for measuring such displacement. Measurement will take place in hospital under supervision of a trained physical therapist. A difference of 2 mm A/P stability is determined as relevant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints Satisfaction and patient outcome scores (PROMS) and functional scores will be assessed pre-operatively, and post-operatively at 12 months and at 2 years (optional) by questionnaires. This will be assessed using following methods; PRE-OP: * Visual Analogue Scale (VAS) for pain at rest and during activity. Note: validated test * Visual Analogue Scale (VAS) for stability. * EQ-5D . Note: validated test * Knee Injury and Orthoarthritis Score (KOOS). Note: validated test * Oxford Knee score. Note: validated test * Knee Society Clinical Rating System (KSCRS). Note: validated test * Kujala Anterior Knee Pain Score. Note: validated test POST-OP: * Visual Analogue Scale (VAS) for pain at rest and during activity. Note: validated test * Visual Analogue Scale (VAS) for stability * EQ-5D. Note: validated test * Knee Injury and Orthoarthritis Score (KOOS). Note: validated test * Oxford Knee score. Note: validated test * Satisfaction score; *would you do it again? (VAS). Note: validated test * Knee Society Clinical Rating System (KSCRS). Note: validated test * Kujala Anterior Knee Pain Score. Note: validated test | — |
Countries
The Netherlands
Outcome results
None listed