Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System

Официальное название

A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Functional Joint Performance via Harris Hip Score (HHS) at 24 Months [Срок оценки: 24 months post-operatively.]
• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From the signing of informed consent up to 24 months post-operatively.]
• Incidence of Clinical Complications [Срок оценки: From the time of signing the informed consent form up to 24 months post-operatively.]

Вторичные конечные точки (1)

• Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS) [Срок оценки: Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, 12, 18, and 24 months post-operatively.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• Subjects currently participating in any other interventional clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Turkey (Türkiye) · 4 центра

• 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

Идентификаторы

NCT: NCT07651735 · INFO TPMHIP P · 2023-190

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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