Arthroplasty Cements Outcomes - A Post-market Follow-up

Last updated: March 24, 2025
Sponsor: Teknimed
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedics

Treatment

Cemented joint arthroplasty

Clinical Study ID

NCT06354543
CA01-TK-ARTHRO
  • Ages > 18
  • All Genders

Study Summary

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels.

Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.

The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be 18 years or older.

  • Be willing to sign an informed consent approved by Institutional Review Board (IRB)or European Commission (EC) (when applicable) or not oppose to the use of theirclinical data in the study

  • For prospective inclusion: be considered for an arthroplasty procedure with one ofthe TEKNIMED orthopaedic cement and/or cement restrictor comprised in this study (primary or revision surgery).

  • For retrospective inclusion: have undergone a primary or revision arthroplastyprocedure with a TEKNIMED orthopaedic cement and/or cement restrictor between the 1st January 2016 and the date of the site initiation visit (SIV).

  • Be informed of the study and not being opposed to the use of their clinical data inthe study or be willing to sign an informed consent during the first follow-up visitfollowing the site initiation (where applicable).

Exclusion

Exclusion Criteria:

  • Patient under trusteeship or guardianship,

  • Women who are pregnant

  • Patient unable to follow the protocol

  • Patient whose vital prognosis is unfavorable (according to investigator's opinion)

Study Design

Total Participants: 1050
Treatment Group(s): 1
Primary Treatment: Cemented joint arthroplasty
Phase:
Study Start date:
December 16, 2020
Estimated Completion Date:
December 31, 2045

Study Description

It is admitted that:

  • Joint replacement is a commonly performed major surgical procedure that has considerable success in alleviating pain and disability;

  • These procedures may be done with the help of a bone cement (PMMA) to fix the prosthesis to the bone (cemented fixation);

  • Most common reasons for primary joint replacement are osteoarthritis, osteonecrosis and trauma;

  • Most common reasons for revision of joint replacement are dislocation, infection, fracture and prothesis loosening;

  • Quality of bone cement have a large influence on long-term implant stability.

TEKNIMED has developed several bone cements and a cement restrictor currently used in arthroplasty procedures.

With the increasing use of these procedures, there is a need of real-life long-term safety and efficacy data on the bone cements.

This retro- and prospective study is performed to assess the safety and performance of TEKNIMED arthroplasty products in their current clinical use.

Connect with a study center

  • CH de Brive

    Brive-la-Gaillarde, Aquitaine 19100
    France

    Active - Recruiting

  • Clinique du Vivarais

    Aubenas, Auvergne-rhône-alpes 07200
    France

    Active - Recruiting

  • Clinique du Val d'Ouest

    Ecully, Auvergne-rhône-alpes 69130
    France

    Active - Recruiting

  • Cabinet de consultation

    Evreux, Eure 27000
    France

    Active - Recruiting

  • Clinique du Dr Henri Guillard

    Coutances, Normandie 50200
    France

    Active - Recruiting

  • Clinique de l'Atlantique

    Puilboreau, Nouvelle-aquitaine 17138
    France

    Active - Recruiting

  • MIROUSE

    Boujan-sur-Libron, Occitanie 34760
    France

    Active - Recruiting

  • Hôpital Européen Marseille

    Marseille, Provence-alpes-cote D'azur 13003
    France

    Active - Recruiting

  • Ospedale Santissima Annunziata

    Cento, Emilie-Romagne 44042
    Italy

    Active - Recruiting

  • Instituto Ortopedico Rizzoli

    Bologna, Émilie-Romagne 40136
    Italy

    Active - Recruiting

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