Arthroplasty Cements Outcomes - A Post-market Follow-up

Teknimed

Status: Enrolling

Conditions: Arthroplasty

Treatments: Device: Cemented joint arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT06354543

CA01-TK-ARTHRO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,050 participants in 21 patient groups

CEMFIX1 Knee primary surgery

Description:

Patients included for primary knee surgery with CEMFIX 1

Treatment:

Device: Cemented joint arthroplasty

CEMFIX1 Knee revision surgery

Description:

Patients included for revision knee surgery with CEMFIX 1

Treatment:

Device: Cemented joint arthroplasty

CEMFIX1 Hip primary surgery

Description:

Patients included for primary hip surgery with CEMFIX 1

Treatment:

Device: Cemented joint arthroplasty

CEMFIX1 Hip revision surgery

Description:

Patients included for revision hip surgery with CEMFIX 1

Treatment:

Device: Cemented joint arthroplasty

CEMFIX1 Shoulder primary surgery

Description:

Patients included for primary shoulder surgery with CEMFIX 1

Treatment:

Device: Cemented joint arthroplasty

CEMFIX1 Shoulder revision surgery

Description:

Patients included for revision shoulder surgery with CEMFIX 1

Treatment:

Device: Cemented joint arthroplasty

CEMFIX3 Hip primary surgery

Description:

Patients included for primary hip surgery with CEMFIX 3

Treatment:

Device: Cemented joint arthroplasty

CEMFIX3 Hip revision surgery

Description:

Patients included for revision hip surgery with CEMFIX 3

Treatment:

Device: Cemented joint arthroplasty

CEMFIX3 Shoulder primary surgery

Description:

Patients included for primary shoulder surgery with CEMFIX 3

Treatment:

Device: Cemented joint arthroplasty

CEMFIX3 Shoulder revision surgery

Description:

Patients included for revision shoulder surgery with CEMFIX 3

Treatment:

Device: Cemented joint arthroplasty

GENTAFIX1 Knee primary surgery

Description:

Patients included for primary knee surgery with GENTAFIX 1

Treatment:

Device: Cemented joint arthroplasty

GENTAFIX1 Knee revision surgery

Description:

Patients included for revision knee surgery with GENTAFIX 1

Treatment:

Device: Cemented joint arthroplasty

GENTAFIX1 Hip primary surgery

Description:

Patients included for primary hip surgery with GENTAFIX 1

Treatment:

Device: Cemented joint arthroplasty

GENTAFIX1 Shoulder primary surgery

Description:

Patients included for primary shoulder surgery with GENTAFIX 1

Treatment:

Device: Cemented joint arthroplasty

GENTAFIX3MV Hip primary surgery

Description:

Patients included for primary hip surgery with GENTAFIX 3MV

Treatment:

Device: Cemented joint arthroplasty

GENTAFIX3MV Hip revision surgery

Description:

Patients included for revision hip surgery with GENTAFIX 3MV

Treatment:

Device: Cemented joint arthroplasty

GENTAFIX3MV Knee revision surgery

Description:

Patients included for revision knee surgery with GENTAFIX 3MV

Treatment:

Device: Cemented joint arthroplasty

GENTAFIX3 Knee revision surgery

Description:

Patients included for revision knee surgery with GENTAFIX 3

Treatment:

Device: Cemented joint arthroplasty

GENTAFIX3 Hip primary surgery

Description:

Patients included for primary hip surgery with GENTAFIX 3

Treatment:

Device: Cemented joint arthroplasty

GENTAFIX3 Hip revision surgery

Description:

Patients included for revision hip surgery with GENTAFIX 3

Treatment:

Device: Cemented joint arthroplasty

CEMSTOP Hip surgery

Description:

Patients included for hip surgery with CEMSTOP

Treatment:

Device: Cemented joint arthroplasty