NCT06374342

BONE SUBSTITUTES OUTCOMES

Name: Clinical Trial NCT06374342
Creator: Teknimed
Keywords: Bone Resorption, Bone defect, device, clinical trial, France,Germany

Safety and Clinical Performance Assessment of Bone Substitutes Used for Bone Voids Filling - A Post-Market Clinical Follow-Up

Teknimed·ClinicalTrials.gov·device·Device trialRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Bone Resorption
Drug/Device/Intervention: Bone defect
Study type: Observational
Intervention type: device

Sponsor & location

Primary sponsor: Teknimed
Location: Mainvilliers,Toulouse,Toulouse,Nancy,Le Mans,München, France,Germany

Timeline & enrollment

Phase: N/A
Start date: Sep 16, 2021
End date: Sep 30, 2032
Enrollment: 425 participants

Primary outcome

Successful bone repair

Summary

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels.  TEKNIMED bone substitutes 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, prospective observational study. Patients will be followed as per local standard medical care of the sites.

ICD-10 classifications

OsteolysisPathological resorption of teethBone donorPostsurgical malabsorption osteoporosisPostsurgical malabsorption osteoporosis with pathological fracture

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06374342
Type: Device Trial

About this record

Access comprehensive clinical trial information for NCT06374342 through Pure Global AI's free database. This phase not specified trial is sponsored by Teknimed and is currently Recruiting. The study focuses on Bone Resorption. Target enrollment is 425 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.