Eligibility criteria
If you would like to participate in this FDA-regulated study, you will need to comply with certain eligibility criteria. The notes below provide a general overview – for a complete list of requirements, click here. Please note that in order to participate you will need to attend study sites based in the United States – for more details on locations, click here.
Do you:
- need to obtain pain relief and improved function?
- have moderate or severe pain when you are both walking or at rest?
- have a diagnosis of osteoarthritis in the medial compartment of the knee and non-surgical treatment options have failed to provide relief for symptoms?
Are you:
- able to understand this clinical trial, co-operate with study procedures, and are willing to return to the clinic and/or hospital for all the required post-operative follow-ups?
- willing to be randomised with either of the devices used in the clinical trial as determined by the randomisation schedule?
You may not qualify if:
- you have a neurological disorder which may interfere or adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis).
- you have a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms.
- you have a diagnosed systemic disease that could affect your welfare or the overall outcome of study (e.g. Paget's disease, renal osteodystrophy).
- you are immunologically suppressed.
- you are on chronic corticosteroid or non-steroidal anti-inflammatory therapy.
- you have diagnosed osteoporosis as evidenced on a DEXA scan (within the last 12 months).
- you have diagnosed rheumatoid arthritis or other forms of inflammatory joint disease.
- you have diagnosed avascular necrosis.
- you have had revision of previously failed prosthesis, failed upper tibial osteotomy or post traumatic arthritis after tibial plateau fracture in the affected knee.
- you have a Body Mass Index >36.
- you have a sensitivity to device material.
- you are are pregnant.
- you are a prisoner, known drug or alcohol abuser, smoker, or have a psychological disorder.
