K-07 Physica KR Fluoroscopy study

• Research type

  Research Study

• Full title

  Physica KR: In vivo kinematic analysis of a novel total knee replacement implant

• IRAS ID

  167566

• Contact name

  Giulia Carli

• Contact email

  clinical.research@limacorporate.com

• Duration of Study in the UK

  3 years, 1 months, 20 days

• Research summary

  The aim of this study is to evaluate with fluoroscopic examination the in-vivo kinematics of a Total Knee Arthroplasty that has a roll-back mechanism close to the natural knee (Physica KR).
  The Physica KR FLuoroscopy study is a national, mono-centre clinical study. It will enrol 19 patients who are already screened, included and operated in the Physica KR clinical trial run in the same study site (K-06 Study protocol 30/10/2013 v 1.0).
  Patients that are recruited into the study will return for the fluoroscopy examination at 6 weeks, 3 months, 6 months and 1 year after surgery.

  Lay Summary of Results

  Study Title
  Analysis of the movement of a new knee device.

  Who carried out the research?
  Doctors from a hospital in the UK and people from a university in the USA. A company which produces medical implants for patients who have a missing joint or bone paid for this study.

  Where and when the study took place?
  The study happened in the UK and USA. It started in June 2015 and closed in January 2023.

  What was this study about?
  The aim of this study is to assess how the knee works after implanting a knee device.

  Who took part in this study?
  Twenty-three people who had knee problems and for this reason a doctor decided they needed to get a knee device.

  How was this study done?
  People involved did radiographs while going up a step, getting down on a knee, and standing with one leg positioned forward with the knee bent.

  What were the results of this study?
  The knee device partially copied the natural movement of the knee.

  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: Sponsor considers the publication of the paper a sharing of the study results
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: No
  If yes, describe or provide URLs to disseminated materials:
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it: Sponsor considers the publication of the paper a sharing of the study results
  Have participants been informed of the results of the study?: No
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected:
  If no, explain why they haven't: Sponsor considers the publication of the paper a sharing of the study results
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled: Sponsor considers the publication of the paper a sharing of the study results
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: NA
  Submitted on: 28/11/2024

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  14/LO/2188

• Date of REC Opinion

  29 Dec 2014

• REC opinion

  Favourable Opinion