Prospective single-arm study to assess the performance and safety of an internal joint distraction device for the treatment of adult patients with knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Pain with the KOOS sub-score of pain at D270 (9 months) comparatively to baseline
Study Overview
Brief Summary
KJD is a joint-preserving treatment for patients under 65 suffering from KOA, where the knee joint is temporarily fully unloaded by the distraction of the tibia and the femur with an external fixator over several weeks. This approach reduces mechanical constraints on the joint by spreading out the arthritic joint surfaces (damaged cartilage). It induces a cascade of molecular signals (growth factors, cytokines, etc.) that stimulate the biological process of cartilage reconstruction (chondrogenesis). Good clinical results include long-term pain reduction, improvement in functional scores with non-inferiority criteria at two years compared to total knee arthroplasty (TKA), cartilage regrowth, and delayed TKA. However, KJD is associated with patient discomfort and a high rate of peri-operative infection due to external fixators.The KDD aims to scientifically validate this new joint distraction approach without external fixators via the use of a subcutaneous implant to deliver results in terms of patient pain relief and assess the safety of the device. Therefore, this clinical study aims to reproduce the distraction procedure described in the literature using the same joint surface spreading principle and intra-articular kinematics. Theoretically, this approach minimises the impact of the procedure on the patient, with better recovery and less impact in the postoperative period.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 65.00 Year(s) to 95.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
Pain with the KOOS sub-score of pain at D270 (9 months) comparatively to baseline
Time Frame: at baseline and 9 months
Secondary Outcomes
- Pain with the KOOS subscore of pain at D135 i.e. 4.5 months compared to baseline.(D135 i.e. 4.5 months)
Investigators
Dr Sachin Tapasvi
Sahyadri Super Speciality Hospital