ConforMIS CCP 11-001 iDuo G2

• Research type

  Research Study

• Full title

  A Prospective, Multicenter Study of the ConforMIS iDuo G2 Bicompartmental Knee Repair System

• IRAS ID

  120185

• Contact name

  Dinesh Nathwani

• Contact email

  d.nathwani@btinternet.com

• Sponsor organisation

  ConforMIS

• Clinicaltrials.gov Identifier

  NCT01564641

• Research summary

  The ConforMIS iDuo® G2 Device is a patient-specific bicompartmental knee resurfacing device designed for the treatment of moderate to severe osteoarthritis. The patient-specific implant is designed from the patient’s unique anatomy using proprietary software which interprets data from the patient’s CT scan. The patient matched implant design is then coupled with unique patient-matched disposable instrumentation designed using the same CT data and software.

  The study objective is to evaluate the performance of the ConforMIS iDuo® G2 Bicompartmental Knee Repair System

  The study design is prospective and multicenter. Subjects will be enrolled based on well-defined criteria for type and severity of knee osteoarthritis as assessed by X-Ray and clinical exam.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  13/LO/1410

• Date of REC Opinion

  25 Nov 2013

• REC opinion

  Further Information Favourable Opinion