Arthroplasty Cements Outcomes - A Post-market Follow-up
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cemented joint arthroplasty.
- Who it may be relevant to
- Registry conditions: Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up
Overview
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.
Interventions
- Device Cemented joint arthroplasty
Joint replacement with cemented prosthetic components
Primary outcome measures
- Survival rate [Time frame: 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)]
Secondary outcome measures (9)
- 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)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 8 centers
- CH de Brive — Brive-la-Gaillarde
- Clinique du Vivarais — Aubenas
- Clinique du Val d'Ouest — Écully
- Cabinet de consultation — Évreux
- Clinique de l'Atlantique — Puilboreau
- Clinique du Dr Henri Guillard — Coutances
- MIROUSE — Boujan-sur-Libron
- Hôpital Européen Marseille — Marseille
Italy · 2 centers
- Instituto Ortopedico Rizzoli — Bologna
- Ospedale Santissima Annunziata — Cento
Identifiers
NCT: NCT06354543 · CA01-TK-ARTHRO