Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

Last updated: January 4, 2024
Sponsor: Contura
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Osteoarthritis

Knee Injuries

Treatment

N/A

Clinical Study ID

NCT05057559
CON-OA-002
  • Ages > 18
  • All Genders

Study Summary

This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with Arthrosamid® according to the Instruction for Use.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Stated willingness to comply with all study procedures and availability for theduration of the study
  • Male or female, aged ≥ 18 years
  • Clinical diagnosis of knee OA

Exclusion

Exclusion Criteria:

  • If an active skin disease or infection is present at or near the injection site
  • If the joint is infected or severely inflamed
  • If a degradable intra-articular injectable such as hyaluronic acid is present, it mustbe expected to be absorbed according to manufacturer's information for the specificproduct, before injection with Arthrosamid®
  • If the patient has previously received treatment with a different non-absorbableinjectable/implant
  • If the patient has received a knee alloplasty or has any foreign material in the knee
  • If the patient has undergone knee arthroscopy within the last 6 months
  • If the patient has haemophilia or is in uncontrolled anticoagulant treatment

Study Design

Total Participants: 201
Study Start date:
April 21, 2021
Estimated Completion Date:
July 01, 2028

Study Description

This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee OA who is eligible for treatment with Arthrosamid® according to the Instruction for Use (IFU).

All subjects will be followed over an observational period of five years with yearly follow-up check points. The first follow-up visit should be six months after the treatment. All follow up visits can be performed as telephone visits.

Connect with a study center

  • The Parker Institute

    Copenhagen,
    Denmark

    Site Not Available

  • Reumatolog i Odense

    Odense,
    Denmark

    Site Not Available

  • AP-HM hopitaux

    Marseille,
    France

    Site Not Available

  • Clinique Saint Louis

    Poissy,
    France

    Site Not Available

  • AmBeNet Hausarztpraxis

    Leipzig,
    Germany

    Site Not Available

  • University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)

    Mainz, 55131
    Germany

    Site Not Available

  • Azienda Ospedaliero Universitaria

    Firenze,
    Italy

    Site Not Available

  • Ospedale San Pietro Fatebenefratelli

    Rom,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria

    Verona,
    Italy

    Site Not Available

  • London North West University Healthcare

    London,
    United Kingdom

    Site Not Available

  • Royal Cornwall Hospital

    Truro,
    United Kingdom

    Site Not Available

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