A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 101
- Locations
- 4
- Primary Endpoint
- Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
Study Overview
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™ 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Tipmed™ Primary Hip Prosthesis
A single prospective cohort of adult patients tracked during routine clinical practice who have undergone primary hip arthroplasty (either total hip arthroplasty or partial hemiarthroplasty) using the Tipmed™ Primary Hip Prosthesis System (including cemented or uncemented stem options based on standard surgical indications).
Intervention: Tipmed™ Primary Hip Prosthesis System (Device)
Outcomes
Primary Outcomes
Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
Time Frame: 24 months post-operatively.
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. 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)
Time Frame: From the signing of informed consent up to 24 months post-operatively.
Continuous monitoring, documentation, and cumulative tracking of the incidence of all adverse events (AEs) and serious adverse events (SAEs) occurring throughout the study period, regardless of their causal relationship to the investigational medical device or surgical procedure. Events will be systematically classified by severity (mild, moderate, severe), outcome, and causality pattern.
Incidence of Clinical Complications
Time Frame: From the time of signing the informed consent form up to 24 months post-operatively.
Evaluation of the rate, frequency, and types of all complications recorded throughout the study period. This includes intraoperative complications captured retrospectively from surgical medical records (such as femoral or acetabular fractures, vascular injuries, and nerve lesions) as well as longitudinal complications documented during the follow-up phase (such as joint dislocation, aseptic loosening, implant breakage, or deep and superficial surgical site infections) associated with the routine clinical utilization of the Tipmed™ Primary Hip Prosthesis System.
Secondary Outcomes
- 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.)