arthritis on the inner side of the knee Medial osteoarthritis
Conditions
Interventions
Medical device: Latella Implant
Surgery: Implantation of the Latella Implant during a surgery. Incision will be
about 5 cm.
Sponsors
Cotera, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. History of pain diagnosed as due to medial osteoarthritis with failure of pain relief from non-operative therapy OR failure of pain relief 6 months post arthroscopic treatment for medial osteoarthritis (see exclusion criteria for excluded procedures) 2. Age: 30 * 65 years 3. Weight: Less than 110 kg 4. Kellgren-Lawrence scores: Grades 2-3 5. Willing and able to understand and sign the informed consent
Exclusion criteria
Exclusion criteria: * Varus angle > 10 degrees * Osteoporosis * Rheumatoid arthritis * Immunosupressive disorders, for example, diabetes * Chronic steroid use * History of heterotopic ossification * Ligament instability * Joint instability * Capsule contracture * Ligament contracture * Radiologic evidence of patellar osteoarthritis which in the opinion of the treating physician would preclude enrollment * History of patellar instability including: Subluxation, Dislocation, Maltracking, Excessive anterior knee pain * Radiologic evidence of lateral osteoarthritis * Post-traumatic osteoarthritis * Lateral osteophytes that would underlie implant region (diagnosed via x-ray) * Free floating bodies * Prior surgery or trauma in or near the intended implant site which would create scar tissue and interfere with the implant surgery. o NOTE: Partial medial meniscectomy will be allowed * Prior anterior cruciate ligament reconstruction * Tight Illiotibial Band or Illiotibial Band Syndrome * Femoral or tibial bone deformity * Bone metabolic disease not associated with osteoarthritis * Disease affecting the connective tissue or muscle * Continued participation in contact sports * Less than 5 year history free of lung, colorectal, breast, thyroid, prostate, or kidney cancer * Less than 5 year history free of primary bone tumors * History of stroke, upper limb or lower limb motor disorders * Bleeding diathesis * Chronic use of anticoagulants * Metal ion allergy * Absolute or relative contraindication for MRI * No fixed abode * Substance abuse (drug or alcohol) * For women of childbearing potential: pregnant, or willing to become pregnant during the course of the clinical investigation * Have been exited from in another clinical study less than 30 days prior to enrollment in this clinical study, currently participating in another clinical study or plan to be enrolled in another clinical study during the course of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety is the primary endpoint of this clinical investigation and will be evaluated by: * Freedom from unanticipated serious device related adverse events up to 12 months after implantation surgery * Freedom from radiographic evidence of screw loosening up to 12 months after implantation surgery. NOTE: This does not include natural disease progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance (technical feasibility) is the secondary endpoint of this clinical investigation and will be evaluated as the ability of the Latella Implant to be placed under the iliotibial band and fixed to the distal, lateral aspect of the femur. Additional exploratory outcome measures are: 1. Patient Reported Outcome scoring of joint specific, disease specific and general Quality of Life measures using: * Knee injury and Osteoarthritis Outcome Score (KOOS) * International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form * 36-Item Short Form Health Survey (SF-36) administered by either the RAND 36 Item Short Form Health Survey (SF-36 specific form) or by the IKDC Current Health Assessment Form, which includes the SF-36 questions * Patient Global Assessment (PGA) * Anterior Knee Pain Scale (Kujala) 2. Radiographic analysis to evaluate : * Joint space width (comparison between baseline and 3, 6, 12 and 24 months post implantation) * Development of ectopic calcification post implantation * Patellar tracking via skyline view. Intra-operative images only, follow-up imaging will be performed by MRI * Standing axis view of leg to determine varus angle and to see if alignment shifts from pre-operative to 3 months post implantation 3. MRI analysis to evaluate: * Meniscal extrusion * Articular cartilage morphology * Subarticular marrow edema * Subarticular bone attrition 4. Three-Dimensional Gait Analysis to evaluate: * Adduction moment * Toe-out angle | — |
Countries
Netherlands
Outcome results
None listed