NCT06354543

Arthroplasty Cements Outcomes - A Post-market Follow-up

Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,050 (estimated)
• Sponsor: Teknimed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthroplasty

Interventions

Type	Name	Description
DEVICE	Cemented joint arthroplasty	Joint replacement with cemented prosthetic components

Timeline

• Start date: 2020-12-16
• Primary completion: 2035-12-01
• Completion: 2045-12-01
• First posted: 2024-04-09
• Last updated: 2025-03-25

Locations

10 sites across 2 countries: France, Italy