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.
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,
Subjects currently participating in any other interventional clinical trial.
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.
Other
Prospective
Tıpmed™ Revision Hip Prosthesis System
DevicePost-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.
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).
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.
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.
Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS)
Periodic monitoring of absolute HHS tracking metrics and category shifts to determine the prospective trajectory of functional recovery over time. The total HHS ranges from 0 (worst possible outcome) to 100 (best possible outcome) and is categorized as follows: Excellent (90-100); Good (80-89); Fair (70-79); Poor (60-69); and Very Poor (\<60). Transition tables will be generated utilizing these classifications to map longitudinal shifts from the retrospectively captured pre-operative baseline value (extracted from patient medical charts) across all prospective post-operative follow-up intervals.
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