ArthroplastyNCT06354543
Arthroplasty Cements Outcomes - A Post-market Follow-up
An observational study of Arthroplasty, run by Teknimed at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty
- What is being tested?
- Cemented joint arthroplasty
- Type of treatment
- Medical device
- How many people
- 1,050 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 16 Dec 2020to Dec 2045
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients for whom a cemented arthroplasty surgery is indicated
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
France8 sites, 8 recruiting
- Recruiting
Clinique du Vivarais
Aubenas, Auvergne-Rhône-Alpes, 07200
Michel MILAIRE, MD, michel.milaire@yahoo.com
Michel MILAIRE, MD
- Recruiting
MIROUSE
Boujan-sur-Libron, Occitanie, 34760
Guillaume MIROUSE, MD, 06 09 51 52 88, gmirouse@gmail.com
Guillaume MIROUSE, MD
- Recruiting
CH de Brive
Brive-la-Gaillarde, Aquitaine, 19100
VAYSSE-VIC Mathieu, MD, mvayssevic@yahoo.fr
Mathieu VAYSSE-VIC, MD
- Recruiting
Clinique du Dr Henri Guillard
Coutances, Normandy, 50200
Olivier COSSART, MD, o.cossart@hotmail.fr
Olivier COSSART, MD
- Recruiting
Clinique du Val d'Ouest
Écully, Auvergne-Rhône-Alpes, 69130
Benoît GIRAUD, MD, b.giraud@chirortho-valdouest.fr
Benoît GIRAUD, MD
- Recruiting
Cabinet de consultation
Évreux, Eure, 27000
Edouard DECRETTE, MD, decrette.edouard@gmail.com
Edouard DECRETTE, MD
- Recruiting
Hôpital Européen Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, 13003
Maxime MUNIER, MD, dr.maxime.munier@gmail.com
Maxime MUNIER, MD
- Recruiting
Clinique de l'Atlantique
Puilboreau, New Aquitaine, 17138
Cédric BOUQUET, MD, docteurbouquet@gmail.com
Cédric BOUQUET, MD
Italy2 sites, 2 recruiting
- Recruiting
Instituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, 40136
Stefano ZAFFAGNINI, MD, stefano.zaffagnini@unibo.it
Stefano ZAFFAGNINI, MD
- Recruiting
Ospedale Santissima Annunziata
Cento, Emilia-Romagna, 44042
Luca CASTAGNINI, MD, luca.castagnini@ausl.fe.it
Luca CASTAGNINI, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthroplasty
- Being tested
- Cemented joint arthroplasty
- Keywords
- cement, prosthesis, arthroplasty, knee, hip, shoulder, joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cemented joint arthroplastyDevice
Joint replacement with cemented prosthetic components
| Study group | Role | What they receive |
|---|---|---|
| CEMFIX1 Knee primary surgery | Patients included for primary knee surgery with CEMFIX 1 Receives: Device: Cemented joint arthroplasty | |
| CEMFIX1 Knee revision surgery | Patients included for revision knee surgery with CEMFIX 1 Receives: Device: Cemented joint arthroplasty | |
| CEMFIX1 Hip primary surgery | Patients included for primary hip surgery with CEMFIX 1 Receives: Device: Cemented joint arthroplasty | |
| CEMFIX1 Hip revision surgery | Patients included for revision hip surgery with CEMFIX 1 Receives: Device: Cemented joint arthroplasty | |
| CEMFIX1 Shoulder primary surgery | Patients included for primary shoulder surgery with CEMFIX 1 Receives: Device: Cemented joint arthroplasty | |
| CEMFIX1 Shoulder revision surgery | Patients included for revision shoulder surgery with CEMFIX 1 Receives: Device: Cemented joint arthroplasty | |
| CEMFIX3 Hip primary surgery | Patients included for primary hip surgery with CEMFIX 3 Receives: Device: Cemented joint arthroplasty | |
| CEMFIX3 Hip revision surgery | Patients included for revision hip surgery with CEMFIX 3 Receives: Device: Cemented joint arthroplasty | |
| CEMFIX3 Shoulder primary surgery | Patients included for primary shoulder surgery with CEMFIX 3 Receives: Device: Cemented joint arthroplasty | |
| CEMFIX3 Shoulder revision surgery | Patients included for revision shoulder surgery with CEMFIX 3 Receives: Device: Cemented joint arthroplasty | |
| GENTAFIX1 Knee primary surgery | Patients included for primary knee surgery with GENTAFIX 1 Receives: Device: Cemented joint arthroplasty | |
| GENTAFIX1 Knee revision surgery | Patients included for revision knee surgery with GENTAFIX 1 Receives: Device: Cemented joint arthroplasty | |
| GENTAFIX1 Hip primary surgery | Patients included for primary hip surgery with GENTAFIX 1 Receives: Device: Cemented joint arthroplasty | |
| GENTAFIX1 Shoulder primary surgery | Patients included for primary shoulder surgery with GENTAFIX 1 Receives: Device: Cemented joint arthroplasty | |
| GENTAFIX3MV Hip primary surgery | Patients included for primary hip surgery with GENTAFIX 3MV Receives: Device: Cemented joint arthroplasty | |
| GENTAFIX3MV Hip revision surgery | Patients included for revision hip surgery with GENTAFIX 3MV Receives: Device: Cemented joint arthroplasty | |
| GENTAFIX3MV Knee revision surgery | Patients included for revision knee surgery with GENTAFIX 3MV Receives: Device: Cemented joint arthroplasty | |
| GENTAFIX3 Knee revision surgery | Patients included for revision knee surgery with GENTAFIX 3 Receives: Device: Cemented joint arthroplasty | |
| GENTAFIX3 Hip primary surgery | Patients included for primary hip surgery with GENTAFIX 3 Receives: Device: Cemented joint arthroplasty | |
| GENTAFIX3 Hip revision surgery | Patients included for revision hip surgery with GENTAFIX 3 Receives: Device: Cemented joint arthroplasty | |
| CEMSTOP Hip surgery | Patients included for hip surgery with CEMSTOP Receives: Device: Cemented joint arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Prosthesis survival defined as time from implantation to revision surgery due to a cement defect.
Measured: 15 years (until the lifetime of the device)
Superficial and/or deep postoperative infection rate.
In the case of cements with gentamicin, superficial and/or deep postoperative infection rate.
Measured: 15 years (until the lifetime of the device)
Secondary outcomes (9)
Pain Level
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
Measured: 5 years
Patients' satisfaction
Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits
Measured: 5 years
Restoration of function
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
Measured: 5 years
Evaluation of function and radiological outcomes
"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)
Measured: 5 years
Complications rate
Evaluation of complications will be assessed on radiological images: cement leakage, implant migration, radiolucent lines, osteolytic zone at the Follow-up visits
Measured: 5 years
Antalgic consumption
Antalgic consumption and the drug type at the Baseline and at the Follow-up visits
Measured: 5 years
Restoration of function
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
Measured: 5 years
Restoration of function
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
Measured: 5 years
Adverse events
All adverse events (such as prosthesis loosening rate, dislocation, deep infection …) occured during surgery and through study completion
Measured: 15 years (until the lifetime of the device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start16 Dec 2020
- Primary completionDec 2035 (estimated)
- Study completionDec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teknimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354543
- Sponsor's protocol ID
- CA01-TK-ARTHRO
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up
- ClinicalTrials.gov ID
- NCT06354543
- Acronym / sponsor ID
- CA01-TK-ARTHRO
- Conditions
- Arthroplasty
- Keywords
- cement, prosthesis, arthroplasty, knee, hip, shoulder, joint
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- TeknimedIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2045 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 21
| Arm | Type | Receives |
|---|---|---|
| CEMFIX1 Knee primary surgery | – | Device: Cemented joint arthroplastyPatients included for primary knee surgery with CEMFIX 1 |
| CEMFIX1 Knee revision surgery | – | Device: Cemented joint arthroplastyPatients included for revision knee surgery with CEMFIX 1 |
| CEMFIX1 Hip primary surgery | – | Device: Cemented joint arthroplastyPatients included for primary hip surgery with CEMFIX 1 |
| CEMFIX1 Hip revision surgery | – | Device: Cemented joint arthroplastyPatients included for revision hip surgery with CEMFIX 1 |
| CEMFIX1 Shoulder primary surgery | – | Device: Cemented joint arthroplastyPatients included for primary shoulder surgery with CEMFIX 1 |
| CEMFIX1 Shoulder revision surgery | – | Device: Cemented joint arthroplastyPatients included for revision shoulder surgery with CEMFIX 1 |
| CEMFIX3 Hip primary surgery | – | Device: Cemented joint arthroplastyPatients included for primary hip surgery with CEMFIX 3 |
| CEMFIX3 Hip revision surgery | – | Device: Cemented joint arthroplastyPatients included for revision hip surgery with CEMFIX 3 |
| CEMFIX3 Shoulder primary surgery | – | Device: Cemented joint arthroplastyPatients included for primary shoulder surgery with CEMFIX 3 |
| CEMFIX3 Shoulder revision surgery | – | Device: Cemented joint arthroplastyPatients included for revision shoulder surgery with CEMFIX 3 |
| GENTAFIX1 Knee primary surgery | – | Device: Cemented joint arthroplastyPatients included for primary knee surgery with GENTAFIX 1 |
| GENTAFIX1 Knee revision surgery | – | Device: Cemented joint arthroplastyPatients included for revision knee surgery with GENTAFIX 1 |
| GENTAFIX1 Hip primary surgery | – | Device: Cemented joint arthroplastyPatients included for primary hip surgery with GENTAFIX 1 |
| GENTAFIX1 Shoulder primary surgery | – | Device: Cemented joint arthroplastyPatients included for primary shoulder surgery with GENTAFIX 1 |
| GENTAFIX3MV Hip primary surgery | – | Device: Cemented joint arthroplastyPatients included for primary hip surgery with GENTAFIX 3MV |
| GENTAFIX3MV Hip revision surgery | – | Device: Cemented joint arthroplastyPatients included for revision hip surgery with GENTAFIX 3MV |
| GENTAFIX3MV Knee revision surgery | – | Device: Cemented joint arthroplastyPatients included for revision knee surgery with GENTAFIX 3MV |
| GENTAFIX3 Knee revision surgery | – | Device: Cemented joint arthroplastyPatients included for revision knee surgery with GENTAFIX 3 |
| GENTAFIX3 Hip primary surgery | – | Device: Cemented joint arthroplastyPatients included for primary hip surgery with GENTAFIX 3 |
| GENTAFIX3 Hip revision surgery | – | Device: Cemented joint arthroplastyPatients included for revision hip surgery with GENTAFIX 3 |
| CEMSTOP Hip surgery | – | Device: Cemented joint arthroplastyPatients included for hip surgery with CEMSTOP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for whom a cemented arthroplasty surgery is indicated
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cemented joint arthroplastyJoint replacement with cemented prosthetic components | Device | CEMFIX1 Hip primary surgery, CEMFIX1 Hip revision surgery, CEMFIX1 Knee primary surgery, CEMFIX1 Knee revision surgery, CEMFIX1 Shoulder primary surgery, CEMFIX1 Shoulder revision surgery, CEMFIX3 Hip primary surgery, CEMFIX3 Hip revision surgery, CEMFIX3 Shoulder primary surgery, CEMFIX3 Shoulder revision surgery, CEMSTOP Hip surgery, GENTAFIX1 Hip primary surgery, GENTAFIX1 Knee primary surgery, GENTAFIX1 Knee revision surgery, GENTAFIX1 Shoulder primary surgery, GENTAFIX3 Hip primary surgery, GENTAFIX3 Hip revision surgery, GENTAFIX3 Knee revision surgery, GENTAFIX3MV Hip primary surgery, GENTAFIX3MV Hip revision surgery, GENTAFIX3MV Knee revision surgery |
Primary outcome
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.
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.
9 secondary outcomes
Pain Level
Time frame: 5 years
Patients' satisfaction
Time frame: 5 years
Restoration of function
Time frame: 5 years
Evaluation of function and radiological outcomes
Time frame: 5 years
Complications rate
Time frame: 5 years
Antalgic consumption
Time frame: 5 years
Restoration of function
Time frame: 5 years
Restoration of function
Time frame: 5 years
Adverse events
Time frame: 15 years (until the lifetime of the device)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, run by Teknimed at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Solange VAN DE MOORTELE, PhD (+33 5 34 25 26 79, s.vandemoortele@teknimed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 15 years (until the lifetime of the device)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.