Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revisio… (NCT07653295) | Clinical Trial Compass
RecruitingNot Applicable
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
Turkey (Türkiye)35 participantsStarted 2024-03-12
Plain-language 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™ Revision Hip Prosthesis System in adult participants undergoing revision 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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals aged 18 years and older,
* Male or female participants,
* Participants who have undergone Revision Hip Arthroplasty (either total revision or partial component revision) for any indication (such as a documented joint failure or prosthesis-related clinical complication),
* Participants in whose revision procedure the Tıpmed™ Revision Hip Prosthesis System components were utilized,
* Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship),
* Participants who have voluntarily signed the written Informed Consent Form (ICF).
Exclusion Criteria:
* Subjects currently participating in any other interventional clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
Timeframe: 24 months post-operatively
2
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From the signing of informed consent up to 24 months post-operatively.
3
Incidence of Clinical Complications
Timeframe: From the time of signing the informed consent form up to 24 months post-operatively.
Trial details
NCT IDNCT07653295
SponsorTIPMED Medical Device Manufacturing Ltd. Co.