A Post-Market Data Collection to Asses the Optetrak® Knee System

• Research type

  Research Study

• Full title

  A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak® Knee System

• IRAS ID

  156454

• Contact name

  Ian Wilson

• Contact email

  ian.wilson@wales.nhs.uk

• Sponsor organisation

  Exactech

• Duration of Study in the UK

  10 years, 0 months, 0 days

• Research summary

  The objective of this data collection is to further affirm the safety and effectiveness of the Optetrak® Knee System product lines. Data will be collected in order to provide post-market subjective and objective evidence of safety and effectiveness. Data may be analyzed to support future presentation and publication of the Optetrak® Knee Systems and will be made available in the event Exactech is required to provide clinical evidence of the post market outcomes of the Optetrak knee devices.

• REC name

  North East - York Research Ethics Committee

• REC reference

  15/NE/0101

• Date of REC Opinion

  8 Sep 2015

• REC opinion

  Further Information Favourable Opinion