A Multi-Center, Open-Label, Interventional Study of Patients with Medial Compartment Knee Osteoarthritis (OA) treated with the KineSpring (Registered Trademark) System

A Multi-Center, Open-Label, Interventional Study to assess pain relief in Patients with Medial Compartment Knee Osteoarthritis (OA) treated with the KineSpring(Registered Trademark) System

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001068257

Acronym

OAKS

Enrollment

Registered

2009-12-14

Start date

2009-11-24

Completion date

2011-08-25

Last updated

2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a multi-center, prospective, open label, safety/efficacy study enrolling up to 30 patients. Safety and efficacy are the primary objectives based on analysis of reported and observed adverse events and the WOMAC validated OA questionnaire(pain component). A series of validated subject-completed questionnaires, a visual analogue scale for pain and formal orthopaedic examination, will be performed over the course of the 60 months at the following intervals: baseline, 6 weeks, 3 months, 6, 12, 24, 36, 48 and 60 months. X-ray and/or MRI data will be collected pre-operatively and the following post operative intervals 6 months, 12, 24, 36, 48, and 60 months.

Interventions

The currently used device name is the KineSpring System. The device is a permanent implant that is fixed on the femoral and tibial components of the knee. The implant is achieved in a single surgery (which should take approximately two hours) and left permanently in place. Each subject will undergo a surgical procedure to implant a permanent knee support device that is an alternative to traditional knee surgeries to treat osteoarthritis (OA) of the knee

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

Male or Female Subjects at least 30 years of age with a minimum 3 month history of primary OA in target knee, with radiographic evidence of OA, continuing pain despite conservative treatment, minimum WOMAC score (Q –A1) of 2, maximum weight of 300 pounds or 136.4 kg.

Exclusion criteria

1. Active infection, sepsis, osteomyelitis or history of septic arthritis in any Joint, 2. Rheumatoid arthritis or other forms of inflammatory joint disease, 3. Modified Kellgren-Lawrence Numerical grading System of grade IV in the patello-femoral compartment of the target, 4. Previous surgery in the target knee within the 3 months prior to screening, 5. Varus alignment >10 degrees, 6. Ligamentous laxity, or meniscal instability as assessed by the investigator, 7. Uncontrolled diabetes mellitus, 8. Moderate to severe osteoporosis, 9. Concomitant immunosuppressive therapy, 10. Metabolic disorders which may impair bone formation, 11. Osteomalacia 12. Distant foci of infections which may spread to the implant site, 13. Rapid joint destruction, marked bone loss or bone resorption apparent on x-ray, 14. Vascular insufficiency, muscular atrophy, neuromuscular disease, 15. Incomplete or deficient soft tissue surrounding the knee, 16. Flexion deformity greater than 15 degrees, 17. Pregnancy or lactation 18. Prisoners

Outcome results