Arthroplasty Cements Outcomes - A Post-market Follow-up

March 24, 2025 updated by: Teknimed

Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1050

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Aquitaine
      • Brive-la-Gaillarde, Aquitaine, France, 19100
        • Recruiting
        • CH de Brive
        • Contact:
        • Principal Investigator:
          • Mathieu VAYSSE-VIC, MD
    • Auvergne-rhône-alpes
      • Aubenas, Auvergne-rhône-alpes, France, 07200
        • Recruiting
        • Clinique du Vivarais
        • Contact:
        • Principal Investigator:
          • Michel MILAIRE, MD
      • Ecully, Auvergne-rhône-alpes, France, 69130
    • Eure
      • Evreux, Eure, France, 27000
        • Recruiting
        • Cabinet de consultation
        • Principal Investigator:
          • Edouard DECRETTE, MD
        • Contact:
    • Normandie
      • Coutances, Normandie, France, 50200
        • Recruiting
        • Clinique du Dr Henri Guillard
        • Contact:
        • Principal Investigator:
          • Olivier COSSART, MD
    • Nouvelle-aquitaine
      • Puilboreau, Nouvelle-aquitaine, France, 17138
        • Recruiting
        • Clinique de l'Atlantique
        • Contact:
        • Principal Investigator:
          • Cédric BOUQUET, MD
    • Occitanie
      • Boujan-sur-Libron, Occitanie, France, 34760
        • Recruiting
        • MIROUSE
        • Principal Investigator:
          • Guillaume MIROUSE, MD
        • Contact:
    • Provence-alpes-cote D'azur
      • Marseille, Provence-alpes-cote D'azur, France, 13003
        • Recruiting
        • Hôpital Européen Marseille
        • Contact:
        • Principal Investigator:
          • Maxime MUNIER, MD
  • Italy
    • Emilie-Romagne
      • Cento, Emilie-Romagne, Italy, 44042
        • Recruiting
        • Ospedale Santissima Annunziata
        • Contact:
        • Principal Investigator:
          • Luca CASTAGNINI, MD
    • Émilie-Romagne
      • Bologna, Émilie-Romagne, Italy, 40136
        • Recruiting
        • Instituto Ortopedico Rizzoli
        • Principal Investigator:
          • Stefano ZAFFAGNINI, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients for whom a cemented arthroplasty surgery is indicated

Description

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 their clinical data in the study
  • For prospective inclusion: be considered for an arthroplasty procedure with one of the TEKNIMED orthopaedic cement and/or cement restrictor comprised in this study (primary or revision surgery).
  • For retrospective inclusion: have undergone a primary or revision arthroplasty procedure 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 in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (where applicable).

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CEMFIX1 Knee primary surgery
Patients included for primary knee surgery with CEMFIX 1
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
CEMFIX1 Knee revision surgery
Patients included for revision knee surgery with CEMFIX 1
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
CEMFIX1 Hip primary surgery
Patients included for primary hip surgery with CEMFIX 1
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
CEMFIX1 Hip revision surgery
Patients included for revision hip surgery with CEMFIX 1
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
CEMFIX1 Shoulder primary surgery
Patients included for primary shoulder surgery with CEMFIX 1
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
CEMFIX1 Shoulder revision surgery
Patients included for revision shoulder surgery with CEMFIX 1
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
CEMFIX3 Hip primary surgery
Patients included for primary hip surgery with CEMFIX 3
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
CEMFIX3 Hip revision surgery
Patients included for revision hip surgery with CEMFIX 3
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
CEMFIX3 Shoulder primary surgery
Patients included for primary shoulder surgery with CEMFIX 3
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
CEMFIX3 Shoulder revision surgery
Patients included for revision shoulder surgery with CEMFIX 3
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
GENTAFIX1 Knee primary surgery
Patients included for primary knee surgery with GENTAFIX 1
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
GENTAFIX1 Knee revision surgery
Patients included for revision knee surgery with GENTAFIX 1
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
GENTAFIX1 Hip primary surgery
Patients included for primary hip surgery with GENTAFIX 1
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
GENTAFIX1 Shoulder primary surgery
Patients included for primary shoulder surgery with GENTAFIX 1
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
GENTAFIX3MV Hip primary surgery
Patients included for primary hip surgery with GENTAFIX 3MV
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
GENTAFIX3MV Hip revision surgery
Patients included for revision hip surgery with GENTAFIX 3MV
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
GENTAFIX3MV Knee revision surgery
Patients included for revision knee surgery with GENTAFIX 3MV
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
GENTAFIX3 Knee revision surgery
Patients included for revision knee surgery with GENTAFIX 3
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
GENTAFIX3 Hip primary surgery
Patients included for primary hip surgery with GENTAFIX 3
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
GENTAFIX3 Hip revision surgery
Patients included for revision hip surgery with GENTAFIX 3
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
CEMSTOP Hip surgery
Patients included for hip surgery with CEMSTOP
Device: Cemented joint arthroplasty
Joint replacement with cemented prosthetic components

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 15 years (until the lifetime of the device)
Prosthesis survival defined as time from implantation to revision surgery due to a cement defect.
15 years (until the lifetime of the device)
Superficial and/or deep postoperative infection rate.
Time Frame: 15 years (until the lifetime of the device)
In the case of cements with gentamicin, superficial and/or deep postoperative infection rate.
15 years (until the lifetime of the device)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Level
Time Frame: 5 years
Pain evaluated by Visual Analogue Scale (VAS): on a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain at the Baseline and at the Follow-up visits
5 years
Patients' satisfaction
Time Frame: 5 years
Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits
5 years
Restoration of function
Time Frame: 5 years
Evaluation of mobility by functional scores: "Constant Score" for the shoulder (scale of 100 points, 100 points is the best mobility) at the baseline and at the Follow-up visits
5 years
Evaluation of function and radiological outcomes
Time Frame: 5 years
"SEDEL Score" at the Follow-up visits ( A: no pejorative functional and radiographic signs / B: patients with stable clinical result but demonstrating progressively evolving radiographic alterations / C: patients with deteriorating functional score but lack of any radiographic explanation / D: patients with bad clinical score associated with progressive radiographic deterioration)
5 years
Complications rate
Time Frame: 5 years
Evaluation of complications will be assessed on radiological images: cement leakage, implant migration, radiolucent lines, osteolytic zone at the Follow-up visits
5 years
Antalgic consumption
Time Frame: 5 years
Antalgic consumption and the drug type at the Baseline and at the Follow-up visits
5 years
Restoration of function
Time Frame: 5 years
Evaluation of mobility by functional scores: "Postel Merle d'Aubigne score" (PMA) for the hip (scale of 18 points, 18 points is the best functional score) at the Baseline and at the Follow-up visits
5 years
Restoration of function
Time Frame: 5 years
Evaluation of mobility by functional scores: "Tegner Lysholm Knee Score" for the knee (scale of 100 points, 100 points is the best functional score) at the Baseline and at the Follow-up visits
5 years
Adverse events
Time Frame: 15 years (until the lifetime of the device)
All adverse events (such as prosthesis loosening rate, dislocation, deep infection …) occured during surgery and through study completion
15 years (until the lifetime of the device)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teknimed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2020

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2045

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CA01-TK-ARTHRO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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