Clinical trial NCT06354543: Arthroplasty Cements Outcomes - A Post-market Follow-up
Official title: Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty
Keywords: cement
prosthesis
arthroplasty
knee
hip
shoulder
joint
Lead sponsor: Teknimed
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for whom a cemented arthroplasty surgery is indicated

Brief 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.

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.

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)

Primary outcomes:
measure: Survival rate
timeFrame: 15 years (until the lifetime of the device)
measure: Superficial and/or deep postoperative infection rate.
timeFrame: 15 years (until the lifetime of the device)
Secondary outcomes:
measure: Pain Level
timeFrame: 5 years
measure: Patients' satisfaction
timeFrame: 5 years
measure: Restoration of function
timeFrame: 5 years
measure: Evaluation of function and radiological outcomes
timeFrame: 5 years
measure: Complications rate
timeFrame: 5 years
measure: Antalgic consumption
timeFrame: 5 years
measure: Restoration of function
timeFrame: 5 years
measure: Restoration of function
timeFrame: 5 years
measure: Adverse events
timeFrame: 15 years (until the lifetime of the device)
Other outcomes:
Locations:
city: Brive-la-Gaillarde
country: France
facility: CH de Brive
state: Aquitaine
city: Aubenas
country: France
facility: Clinique du Vivarais
state: Auvergne-rhône-alpes
city: Ecully
country: France
facility: Clinique du Val d'Ouest
state: Auvergne-rhône-alpes
city: Evreux
country: France
facility: Cabinet de consultation
state: Eure
city: Coutances
country: France
facility: Clinique du Dr Henri Guillard
state: Normandie
city: Puilboreau
country: France
facility: Clinique de l'Atlantique
state: Nouvelle-aquitaine
city: Boujan-sur-Libron
country: France
facility: MIROUSE
state: Occitanie
city: Marseille
country: France
facility: Hôpital Européen Marseille
state: Provence-alpes-cote D'azur
city: Cento
country: Italy
facility: Ospedale Santissima Annunziata
state: Emilie-Romagne
city: Bologna
country: Italy
facility: Instituto Ortopedico Rizzoli
state: Émilie-Romagne
Study officials:
References: