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: - History of pain for at least 6 months due to medial osteoarthritis, with failure of pain relief from non*operative therapy OR from arthroscopic treatment for medial osteoarthritis (see exclusion criteria for excluded procedures) - Age: 30 * 70 years - Weight: Less than 136 kg - Kellgren*Lawrence scores: Grades 2*3 - Baseline KOOS pain score of * 60 - Baseline medial knee pain Numerical Rate Scale (NRS) (while walking) score * 4 - Willing and able to understand and sign the informed consent
Exclusion criteria
Exclusion criteria: * Varus angle > 10 degrees (mechanical axis) * Active Flexion > 140 degrees * Joint flexion contracture > 10 degrees * Contralateral knee pain (Baseline medial knee pain NRS (while walking) score * 3) * Osteoporosis or other condition (e.g., hyperthyroidism, Paget*s disease, scurvy) that could compromise bone quality * Permanent implant in or around the knee joint * Rheumatoid arthritis * Osteoarthritis in non-knee joint of the lower limb or lower back that impacts activities of daily living * Immunosupressive disorders (e.g., diabetes) * Chronic (6 months or longer) steroid use (with the exception of inhaled steroids) * History of heterotopic ossification * Ligament instability * Joint instability * Symptomatic evidence of moderate to severe OA in the lateral and/or patellofemoral compartments * Lateral osteophytes that would underlie implant region (diagnosed via x-ray) * Free floating bodies * Post-traumatic osteoarthritis * Arthroscopy within the last 3 months * Meniscal debridement within the last 6 months * Prior anterior cruciate ligament reconstruction * Tight Iliotibial Band or Iliotibial Band Syndrome * Femoral or tibial bony deformity * Disease affecting the connective tissue or muscle * Continued participation in competitive or high-impact sports (e.g.,Tegner score >6) * Less than 5 year history free of 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 (with the exception of aspirin) * Known metal ion allergy to titanium alloy, aluminum, or vanadium alloy * Absolute or relative contraindication for MRI * Substance abuse (drug or alcohol) * For women of childbearing potential: pregnant, or planning to become pregnant during the course of the clinical investigation * Litigation for or workers compensation for musculoskeletal injuries or disorders * Are currently participating in, or have been recently exited from (within 30 days of enrollment in this study), or plan to be enrolled in another clinical study for a device or drug that may impact participation or outcome of this study * Has a condition, disorder or other factor that, in the investigator*s opinion, would interfere with study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the mean change in KOOS pain score at 6 Months after treatment with the Latella Implant. The primary safety endpoint is the surgical re-intervention rate during the 6 Month period following implantation of the Latella device. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be assessed: * Mean change in KOOS function score at 6, 12 and 24 Months post treatment * Mean change in medial knee pain NRS (while walking) at 6, 12 and 24 Months post treatment * Mean change in IKDC score at 6, 12 and 24 Months post treatment * Device and procedure related complications rate at 12 and 24 months post treatment * KOOS responder rate calculated based on the Osteoarthritis Research Society International (OARSI) defined OARSI-OMERACT responder criteria at 6, 12 and 24 months post treatment * Proportion of subjects reaching MCID in KOOS pain score at 6, 12 and 24 months post treatment. * Mean change in KOOS pain score at 12 and 24 Months post treatment * Surgical re-intervention rate at 12 and 24 months post treatment Additional supportive outcome measures are based on the following evaluations: Patient Questionnaires will be used to measure therapy specific and general Quality of Life: * Western Ontario and McMaster Universities Arthritis Index (WOMAC) * Pain, Function, Stiffness NOTE: KOOS contains the full and original version of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire and thus WOMAC scores can be calculated from the KOOS questionnaire. * Knee injury and Osteoarthritis Outcome Score (KOOS) * Quality of Life * EQ-5D * Patient Global Assessment Radiographic analysis will be used to evaluate: * Joint space width (comparison between baseline and 12 and 24 months post implantation) * Changes in standing axis view leg varus angle (comparison between baseline and 12 months post implantation) MRI analysis will be used to evaluate: * Cartilage loss (comparison between baseline and 12 and 24 months post implantation) 3-Dimensional Gait Analysis will be used to evaluate: * Adduction moment * Toe-out angle | — |
Countries
Netherlands
Outcome results
None listed