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12/9/14

iUni® 2-Year Clinical Outcomes Data

At the 2014 ICJR Transatlantic Orthopaedic Congress new two-year clinical outcomes data for iUni® was presented. The prospective, single-arm, multi-center study was designed to evaluate effectiveness and long-term survivability of the iUni® system. At two years the analysis included 118 patients (120 knees) and saw the following results:

  • Range of motion increased an average of 11° from 120° pre-operatively to 131° at two years post-op.
  • Average KSS Knee Score was 94, and KSS Function score was 91
  • Average WOMAC score was 90
  • 99% of patients reported that they were satisfied at two years, with 89% reporting they were “very” or “extremely” satisfied
  • 89% of patients stated that the movement of their knee felt natural

Downloads

"Customized, Individually Made Unicondylar Knee Replacement: A Prospective, Multicenter Study of 2-Year Clinical Outcomes" (Sinha et al)

Important Safety Information

The iUni Knee Replacement System (KRS) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components. Only a licensed physician can help you determine the appropriate medical treatment. There are potential risks to knee replacement surgery, and individual results may vary. Before making any decisions concerning medical treatment, consult your physician regarding your options and the risks of those options. The longevity, performance and feel of any knee implant will depend on various factors, including your physical condition, your activity level, adherence to your physician’s instructions, and other factors.

Candidates for unicondylar knee replacement include those with:

  • joint impairment due to osteoarthritis or traumatic arthritis of the knee,
  • previous femoral condyle or tibial plateau fracture, creating loss of function,
  • valgus or varus deformity of the knee,
  • revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The implant is intended for cemented use only.

Caution: Federal law restricts this device to sale by or on the order of a physician.

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