Osteoarthritis of the knee Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Interventions
Arthroplasty of the knee. There is only one treatment arm as the results of this arm will be compared to a historical control. The surgical procedure lasts 1.5 to 2 hours. Enrolment will take place ov
Sponsors
Moximed Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 25 years, either sex 2. Diagnosis of medial OA of the target knee based on American College of Rheumatology (ACR) Clinical and Radiographic or Clinical Classification criteria for osteoarthritis with a minimum 12 month history 3. Continued knee pain despite minimum 3 months of conservative therapy, (i.e., physical therapy, bracing, orthotics, systemic or injected medications) 4. Knee flexion greater than or equal to 90 degrees 5. KSS knee and function scores less than 70 6. Weight greater than 60 kg 7. Ability to tolerate antibiotics 8. Willing and able to give voluntary written informed consent to participate in this clinical investigation 9. Prepared to consent to the transfer of his/her information to third parties 10. Willing to undertake the required investigational procedures and willing to return for the required follow-up evaluations
Exclusion criteria
Exclusion criteria: 1. Active infection, sepsis or osteomyelitis, history of infection in the target knee or distant foci of infections which may spread to the implant site 2. Rheumatoid arthritis or other forms of inflammatory joint disease 3. Significant OA in lateral or patellofemoral compartment 4. Previous surgery in the target knee within 12 months prior to screening 5. Previous osteotomy or failed knee endoprostheses of any kind in the target knee 6. Tibial-femoral varus or valgus alignment greater than 10 degrees 7. Ligamentous or meniscal instability as assessed by the Investigator 8. Concomitant immunosuppressive therapy 9. Paget's disease or metabolic disorders which may impair bone formation 10. Osteomalacia or moderate to severe osteoporosis, rapid joint destruction, marked bone loss or bone resorption noted on x-ray 11. Charcot's joint disease or other severe neurosensory deficits 12. Incomplete or deficient soft tissue surrounding the knee as assessed by the Investigator 13. Flexion deformity greater than 10 degrees 14. Uncontrolled diabetes mellitus or other significant co-morbidities 15. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc) or other factor (e.g. planned relocation, uncooperative patient) that the Investigator feels would interfere with study participation 16. The patient is pregnant or lactating 17. Historic or ongoing litigation for or participation in workers compensation for musculoskeletal injuries or disorders 18. Subjects who are currently enrolled in another clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The KSS Function score 6 months post-KineSpring™ UKA System surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Procedural success (i.e., successful implantation of the device) 2. Treatment-emergent AEs at surgery, 2 and 6 weeks, 3, 6, 12, 18, and 24 months (to include device malfunctions/unanticipated adverse device evaluations (UADEs) 3. Subject reported symptom severity changes from baseline measurement at 6 weeks, 3, 6, 12, 18, and 24 months in the following criteria: 3.1. KOOS score 3.2. EuroQol (EQ-5D) 3.3. Lysholm Knee Scale 3.4. Knee Specific Pain Scale 3.5. Investigator's assessment of patients' global status 3.6. Activity Profile 3.7. Patient Overall Treatment Evaluation 4. KSS knee and function scores at 6 weeks, 3, 6, 12, 18, and 24 months 5. KineSpring™ UKA System stability through evaluation of radiographic parameters at 3, 6, 12, and 24 month follow-up | — |
Countries
Belgium, United Kingdom
Outcome results
None listed