LUNA CON-OA-002 V3.0 09Aug2021

• Research type

  Research Study

• Full title

  Prospective, observational, open-label, clinical investigation of intra-articular Arthrosamid® injection in subjects with knee osteoarthritis (“LUNA”)

• IRAS ID

  313369

• Contact name

  Maimen Shyam

• Contact email

  Maimen.shyam@nhs.net

• Sponsor organisation

  Contura International A/S

• Clinicaltrials.gov Identifier

  NCT05057559

• Duration of Study in the UK

  6 years, 0 months, 0 days

• Research summary

  200 patients up to 12 sites in Europe will be enrolled. Recruitment period up to 1 year. Device will be injected to knee joint according to Instruction For Use at the V1 Baseline in investigation centers, according to routine practice.Follow-up data collection will be done remotely on the phone during 7 phone calls, answers to questionnaires PGA and WOMAC will be collected. Total duration of observation 60 months. Results of all patients undergoing the procedure will be collected, analyzed and reported.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  22/WM/0171

• Date of REC Opinion

  11 Oct 2022

• REC opinion

  Further Information Favourable Opinion