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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2035

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2045

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Arthroplasty

Clinical Trials on Cemented joint arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings