Safety and Feasibility of a Load Bypass Knee Support System (LBKSS) for the Treatment of Osteoarthritis

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000451303

Acronym

OASYS

Enrollment

Registered

2008-09-15

Start date

2008-06-17

Completion date

2009-01-23

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, feasibility study enrolling up to 30 patients. Safety and feasibility are the primary objectives based on completion of surgical implantation and analysis of reported and observed adverse events. 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, 24-48 hours post-op, 2 weeks, 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, 2 weeks, 6 months, 12 months, 24 months and 60 months.

Interventions

The currently used device name is the LBKSS. 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 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 65 Years

Healthy volunteers

Inclusion criteria

Subjects who have previously failed medical therapy for OA of the knee weighing less than 125kgs and are willing and able to comply with the study requirements

Exclusion criteria

1) Knees that are multi-dimensionally unstable in addition to being Anterior cruciate ligament (ACL) deficient 2) Uncontrolled diabetes 3) Rheumatoid Arthritis of the knee 4) Active Smoker 5) Previous knee prosthesis in the affected knee 6) History of major traumatic injury in the affected knee 7) Moderate to severe osteoporosis 8) Lateral compartment OA 9) Mild to severely symptomatic Patello-Femoral disease 10) Arthroscopic surgery with the previous 3 months

Outcome results