Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
Recruiting · NCT07651735 · Observational (researchers observe without assigning treatment) · Lead sponsor: TIPMED Medical Device Manufacturing Ltd. Co.
View the official record on ClinicalTrials.gov →Interventions studied
Tipmed™ Primary Hip Prosthesis System
What this trial is about
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Primary Hip Prosthesis System in adult subjects undergoing primary hip arthroplasty. The study aims to gather real-world clinical evidence on the 24-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Individuals aged 18 years and older,
- Male or female participants,
- Subjects who have undergone Primary Hip Arthroplasty (either total or partial) for any indication,
- Subjects in whose surgical procedure the Tipmed™ Primary Hip Prosthesis System components were utilized.
- Subjects who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship).
- Subjects who have voluntarily signed the written Informed Consent Form (ICF).
Exclusion criteria
- Subjects currently participating in any other interventional clinical trial.
Where it is running
4 locations listed.
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital - Balıkesir, Turkey (Türkiye)
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital - Balıkesir, Turkey (Türkiye)
- Dokuz Eylül University Research and Application Hospital - Izmir, Turkey (Türkiye)
- Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital - Izmir, Turkey (Türkiye)