Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
2 other identifiers
observational
35
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2024
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2024
CompletedFirst Submitted
Initial submission to the registry
June 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
June 17, 2026
June 1, 2026
4.8 years
June 11, 2026
June 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
The proportion of participants achieving 'Excellent' (≥ 90 points) or 'Good' (80-89 points) clinical performance based on the Harris Hip Score (HHS) will be evaluated to demonstrate device efficacy. The HHS is a clinician-administered tool that quantitatively scores hip function across domains including pain, function, functional activities, absence of deformity, and range of motion (ROM), with a total score ranging from 0 (worst possible outcome) to 100 (best possible outcome).
24 months post-operatively
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Continuous monitoring, documentation, and cumulative tracking of the incidence and frequency of all adverse events (AEs) and serious adverse events (SAEs) occurring throughout the study surveillance period, regardless of their causal relationship to the investigational revision medical device or surgical procedure. Events will be systematically classified by intensity/severity (mild, moderate, severe), outcome characteristics, and causality relationship pattern.
From the signing of informed consent up to 24 months post-operatively.
Incidence of Clinical Complications
Evaluation of the rate, frequency, and types of all clinical complications recorded throughout the study. This includes intraoperative complications captured retrospectively from surgical medical charts (such as femoral or acetabular perforation/fractures, vascular injuries, and nerve lesions including peroneal or sciatic nerve injuries) as well as longitudinal complications documented during the prospective follow-up phase (such as joint dislocation, aseptic loosening, implant failure/breakage, deep or superficial surgical site infections, and subsequent re-revision/reoperation rates) associated with the routine clinical utilization of the Tıpmed™ Revision Hip Prosthesis System.
From the time of signing the informed consent form up to 24 months post-operatively.
Secondary Outcomes (1)
Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS)
Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, 12, 18, and 24 months post-operatively.
Study Arms (1)
Tıpmed™ Revision Hip Prosthesis
A single prospective, multi-center, non-interventional cohort of adult patients tracked during routine clinical practice who have undergone revision hip arthroplasty using the Tıpmed™ Revision Hip Prosthesis System. Patients are enrolled following revision surgery indicated for clinical complications such as aseptic loosening, periprosthetic infection, joint instability, dislocation, or periprosthetic fractures. The cohort captures real-world clinical data based on standard orthopedic indications without any study-mandated modifications to the routine surgical choice.
Interventions
Post-market evaluation of the commercially available, CE-marked Tıpmed™ Revision Hip Prosthesis System during routine revision orthopedic care. Surgeon-directed device configurations are utilized based on patient-specific bone loss and anatomy, incorporating various mono-block or modular femoral stems, modular femoral body components, and femoral necks. Acetabular reconstruction elements encompass various configurations including acetabular cups, bipolar cups, and titanium metal shells with modular inserts, paired with dedicated bone-anchoring options such as acetabular rings, reinforcement cages, and anatomical rings based on standard clinical routine. In strict adherence to the prospective observational design of this registry, no investigational, experimental, or non-routine surgical interventions are performed.
Eligibility Criteria
The study population comprises adult patients aged 18 years and older, of both sexes, who have undergone revision hip arthroplasty (either total revision or partial component revision) due to a documented joint failure or clinical complication at participating multi-center orthopedic clinics. The cohort specifically represents individuals whose surgical treatment involved the standard clinical implantation of the Tıpmed™ Revision Hip Prosthesis System configurations. Participants who are legally competent, free of legal constraints, and provide written informed consent to allow their routine baseline parameters and prospective post-operative clinical, laboratory, and radiographic surveillance data to be documented will be consecutively enrolled.
You may qualify if:
- 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).
You may not qualify if:
- Subjects currently participating in any other interventional clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
Balıkesir, 10100, Turkey (Türkiye)
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
Balıkesir, 10900, Turkey (Türkiye)
Dokuz Eylül University Research and Application Hospital
Izmir, 35330, Turkey (Türkiye)
Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
Izmir, 35390, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmet Karakaşlı, Professor
Dokuz Eylul University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2026
First Posted
June 17, 2026
Study Start
March 12, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
March 31, 2029
Last Updated
June 17, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
Individual Participant Data (IPD) will not be shared publicly due to the strict confidentiality requirements, personal data protection legislation (KVKK Law No.6698), and commercial intellectual property rights policies of the sponsor.