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Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System

RECRUITINGSponsored by TIPMED Medical Device Manufacturing Ltd. Co.
Actively Recruiting
SponsorTIPMED Medical Device Manufacturing Ltd. Co.
Started2024-03-12
Est. completion2028-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07651735

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions6

ArthritisFemoral Neck FracturesHemiarthroplastyJoint DiseasesOsteoarthritis (OA) of the HipTotal Hip Arthroplasty (THA)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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