Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Knee Distraction Device
Commercial brand name: not available: The Knee Distraction Device is an internal fixation device, with plates implanted in contact with the femur and tibia, and
Sponsors
Dr Sachin Tapasvi
Eligibility
Inclusion criteria
Inclusion criteria: Adults =65 years old eligible for a surgery of the knee Male and female patients suffering from tibiofemoral OA Kellgren Lawrence grade II, III, or IV Painful knee despite conservative treatments like physiotherapy, infiltration, well-managed medical treatment more than 6 months).Pain more than 40 mm in VAS at D0 For women Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it until the end of the study Good general and mental health within the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination Able and willing to participate in the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form
Exclusion criteria
Exclusion criteria: Epiphyseal deformity no frontal deformation greater than MPTA 83;91°, mLDFA 84;91° and total bone deformity more than 5°, sagittal deformation PPTS more than 12° Patient with more than 5° of extension deficit Pregnant or breastfeeding women BMI more than 35 Bone diseases that may interfere with proper screws fixation Acute or chronic local or systemic infections Allergy to one of the materials used or sensitivity to foreign bodies Uncontrolled diabetes HbA1C more than 7.5 Painful patellofemoral OA Patient with significant pain disorders other than tibiofemoral OA Taking corticosteroids within the past 3 months Injection of hyaluronic acid, corticosteroids, or other treatment on the treated joint in the last six months prior to enrollment BW more than 120 kg Large medial osteophytes that may interfere with plate positioning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain with the KOOS sub-score of pain at D270 (9 months) comparatively to baselineTimepoint: at baseline and 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain with the KOOS subscore of pain at D135 i.e. 4.5 months compared to baseline.Timepoint: D135 i.e. 4.5 months | — |
Countries
India
Contacts
Public ContactDr Sachin Tapasvi
Sahyadri Super Speciality Hospital
Outcome results
None listed