Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tipmed™ Primary Hip Prosthesis System.
- Who it may be relevant to
- Registry conditions: Total Hip Arthroplasty (THA), Hemiarthroplasty, Osteoarthritis (OA) of the Hip, Femoral Neck Fractures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
Overview
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.
Detailed description
This prospective, observational, PMCF study evaluates the short-to-medium-term safety and efficacy data of the Tipmed™ Primary Hip Prosthesis System in patients undergoing primary hip arthroplasty (total or partial) across 4 clinical centers in Turkey. A total of 101 eligible participants will be enrolled in accordance with the pre-defined inclusion and exclusion criteria. Pre-operative demographic details, medical history, and surgical parameters will be captured retrospectively from patient medical charts. Following the baseline surgical procedure, subjects will undergo a 24-month clinical follow-up period consisting of 6 routine post-operative assessment windows: at 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months. At each longitudinal visit, investigators will complete a study-specific Case Report Form (CRF) to document objective clinical indicators. Clinical performance and joint functionality will be quantitatively monitored utilizing the Harris Hip Score (HHS). Safety endpoints will be continuously evaluated by identifying, classifying, and reporting any adverse events (AEs), serious adverse events (SAEs), implant-related complications (such as dislocation, aseptic loosening, or infection), and hardware deficiencies. Radiological findings (implant orientation, migration, osteointegration) and laboratory indicators (such as C-Reactive Protein and Sedimentation Rate) will be documented when available as part of standard medical surveillance.
Demographic characteristics, clinical parameters, and efficacy/safety outcomes will be summarized using descriptive statistics. Stratified analyses will be conducted based on the specific type of primary surgical intervention. Separate subgroup analyses will be executed for study participants who undergo partial hip arthroplasty (hemiarthroplasty) to isolate and evaluate their outcomes independently from the patients treated with total hip arthroplasty. Categorical variables across these subgroups will be compared using the Chi-square test or Fisher's exact test, as appropriate.
Interventions
- Device Tipmed™ Primary Hip Prosthesis System
Post-market utilization of the commercially available Tipmed™ Primary Hip Prosthesis System during routine orthopedic care. Device components include various configurations such as cemented or uncemented stems (anatomic or square cross-section), acetabular cups, bipolar cups, and titanium metal shells fitted according to standard clinical routine and patient anatomy. No investigational or non-routine interventions are performed as part of this observational registry.
Primary outcome measures
- Functional Joint Performance via Harris Hip Score (HHS) at 24 Months [Time frame: 24 months post-operatively.]
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: From the signing of informed consent up to 24 months post-operatively.]
- Incidence of Clinical Complications [Time frame: From the time of signing the informed consent form up to 24 months post-operatively.]
Secondary outcome measures (1)
- Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS) [Time frame: Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, 12, 18, and 24 months post-operatively.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Turkey (Türkiye) · 4 centers
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk Ci — Balıkesir
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye — Balıkesir
- Dokuz Eylül University Research and Application Hospital — Izmir
- Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy — Izmir
Identifiers
NCT: NCT07651735 · INFO TPMHIP P · 2023-190