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

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.

This prospective, multi-center, observational, Post-Market Clinical Follow-Up (PMCF) study evaluates the short-to-medium-term safety and efficacy data of the Tipmed™ Revision Hip Prosthesis System in adult patients undergoing revision hip arthroplasty (total or partial) across participating clinical centers in Turkey. A total of 35 eligible participants will be enrolled in accordance with the pre-defined inclusion and exclusion criteria. Pre-operative demographic details, comprehensive medical history, previous arthroplasty data, and specific indications for revision surgery (such as aseptic loosening, infection, dislocation, or periprosthetic fractures) will be captured retrospectively from patient medical charts. Following the baseline revision 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 and survival indicators. Clinical performance and joint functionality profiles 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 (including re-revision rates, dislocation, aseptic loosening, infection, or nerve/vascular injuries), and hardware deficiencies. Radiological findings (implant positioning, component orientation, migration, osteointegration, and status of acetabular/femoral bone loss) and laboratory indicators (such as C-Reactive Protein and Sedimentation Rate) will be documented when available as part of standard medical surveillance.

Demographic characteristics, baseline clinical parameters, and longitudinal efficacy/safety outcomes will be summarized using descriptive statistics. Stratified analyses will be conducted based on the specific type of revision surgical intervention. Separate subgroup analyses will be executed for study participants who undergo partial revision hip arthroplasty to isolate and evaluate their clinical outcomes independently from the patients treated with total revision hip arthroplasty. Categorical variables across these subgroups will be compared using the Chi-square test or Fisher's exact test, as appropriate.

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.