Arthroplasty Cements Outcomes - A Post-market Follow-up

NCT06354543 | Recruiting

• 1 other identifier: CA01-TK-ARTHRO
• Study Type: observational
• Target: 1,050
• Locations: 2 countries
• Sites: 10

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.

Conditions

Arthroplasty

Keywords

cement; prosthesis; arthroplasty; knee; hip; shoulder; joint

Outcome Measures

Primary Outcomes (2)

• Survival rate

  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.

  In the case of cements with gentamicin, superficial and/or deep postoperative infection rate.

  15 years (until the lifetime of the device)

Secondary Outcomes (9)

• Pain Level

  5 years

• Patients' satisfaction

  5 years

• Restoration of function

  5 years

• Evaluation of function and radiological outcomes

  5 years

• Complications rate

  5 years

Study Arms (21)

CEMFIX1 Knee primary surgery

Patients included for primary knee surgery with CEMFIX 1

Device: Cemented joint arthroplasty

CEMFIX1 Knee revision surgery

Patients included for revision knee surgery with CEMFIX 1

Device: Cemented joint arthroplasty

CEMFIX1 Hip primary surgery

Patients included for primary hip surgery with CEMFIX 1

Device: Cemented joint arthroplasty

CEMFIX1 Hip revision surgery

Patients included for revision hip surgery with CEMFIX 1

Device: Cemented joint arthroplasty

CEMFIX1 Shoulder primary surgery

Patients included for primary shoulder surgery with CEMFIX 1

Device: Cemented joint arthroplasty

CEMFIX1 Shoulder revision surgery

Patients included for revision shoulder surgery with CEMFIX 1

Device: Cemented joint arthroplasty

CEMFIX3 Hip primary surgery

Patients included for primary hip surgery with CEMFIX 3

Device: Cemented joint arthroplasty

CEMFIX3 Hip revision surgery

Patients included for revision hip surgery with CEMFIX 3

Device: Cemented joint arthroplasty

CEMFIX3 Shoulder primary surgery

Patients included for primary shoulder surgery with CEMFIX 3

Device: Cemented joint arthroplasty

CEMFIX3 Shoulder revision surgery

Patients included for revision shoulder surgery with CEMFIX 3

Device: Cemented joint arthroplasty

GENTAFIX1 Knee primary surgery

Patients included for primary knee surgery with GENTAFIX 1

Device: Cemented joint arthroplasty

GENTAFIX1 Knee revision surgery

Patients included for revision knee surgery with GENTAFIX 1

Device: Cemented joint arthroplasty

GENTAFIX1 Hip primary surgery

Patients included for primary hip surgery with GENTAFIX 1

Device: Cemented joint arthroplasty

GENTAFIX1 Shoulder primary surgery

Patients included for primary shoulder surgery with GENTAFIX 1

Device: Cemented joint arthroplasty

GENTAFIX3MV Hip primary surgery

Patients included for primary hip surgery with GENTAFIX 3MV

Device: Cemented joint arthroplasty

GENTAFIX3MV Hip revision surgery

Patients included for revision hip surgery with GENTAFIX 3MV

Device: Cemented joint arthroplasty

GENTAFIX3MV Knee revision surgery

Patients included for revision knee surgery with GENTAFIX 3MV

Device: Cemented joint arthroplasty

GENTAFIX3 Knee revision surgery

Patients included for revision knee surgery with GENTAFIX 3

Device: Cemented joint arthroplasty

GENTAFIX3 Hip primary surgery

Patients included for primary hip surgery with GENTAFIX 3

Device: Cemented joint arthroplasty

GENTAFIX3 Hip revision surgery

Patients included for revision hip surgery with GENTAFIX 3

Device: Cemented joint arthroplasty

CEMSTOP Hip surgery

Patients included for hip surgery with CEMSTOP

Device: Cemented joint arthroplasty

Interventions

Cemented joint arthroplasty DEVICE

Joint replacement with cemented prosthetic components

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients for whom a cemented arthroplasty surgery is indicated

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Teknimed: lead

Study Sites (10)

CH de Brive

Brive-la-Gaillarde, Aquitaine, 19100, France

RECRUITING

Clinique du Vivarais

Aubenas, Auvergne-Rhône-Alpes, 07200, France

RECRUITING

Clinique du Val d'Ouest

Écully, Auvergne-Rhône-Alpes, 69130, France

RECRUITING

Cabinet de consultation

Évreux, Eure, 27000, France

RECRUITING

Clinique du Dr Henri Guillard

Coutances, Normandy, 50200, France

RECRUITING

Clinique de l'Atlantique

Puilboreau, Nouvelle-Aquitaine, 17138, France

RECRUITING

MIROUSE

Boujan-sur-Libron, Occitanie, 34760, France

RECRUITING

Hôpital Européen Marseille

Marseille, Provence-Alpes-Côte d'Azur Region, 13003, France

RECRUITING

Instituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

RECRUITING

Ospedale Santissima Annunziata

Cento, Emilia-Romagna, 44042, Italy

RECRUITING

Central Study Contacts

Solange VAN DE MOORTELE, PhD

CONTACT

+33 5 34 25 26 79; s.vandemoortele@teknimed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 9, 2024
• Study Start: December 16, 2020
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2045
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8); IT (2)