Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
10 de junio de 2026 actualizado por: TIPMED Medical Device Manufacturing Ltd. Co.
A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary 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™ 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
101
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yasemin Önel, Sponsor Rep
- Número de teléfono: +90 232 479 33 22
- Correo electrónico: yaseminonel@tipmed.com
Ubicaciones de estudio
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Balıkesir, Turquía (Türkiye), 10100
- Reclutamiento
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
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Contacto:
- Özgün Karakuş, Professor
- Número de teléfono: +90 266 460 4000
- Correo electrónico: ozgunkarakus@hotmail.com
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Investigador principal:
- Özgün Karakuş, Professor
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Sub-Investigador:
- fatih Işık, MD, Spec.
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Sub-Investigador:
- Fatih Palıt, MD, Spec.
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Sub-Investigador:
- Uğur Yüzügüldü, MD, Spec.
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Sub-Investigador:
- Mücahit Çelik, MD, Spec.
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Balıkesir, Turquía (Türkiye), 10700
- Reclutamiento
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
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Contacto:
- Cemal Aydın, MD, Spec.
- Número de teléfono: +90 266 412 6999
- Correo electrónico: cemalaydın80@hotmail.com
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Investigador principal:
- Cemal Aydın, MD, Spec.
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Izmir, Turquía (Türkiye), 35330
- Reclutamiento
- Dokuz Eylül University Research and Application Hospital
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Contacto:
- Ahmet Karakaşlı, Professor
- Número de teléfono: +90 (232) 412 22 22
- Correo electrónico: karakasliahmet@gmail.com
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Investigador principal:
- Ahmet Karakaşlı, Professor
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Izmir, Turquía (Türkiye), 35390
- Reclutamiento
- Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
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Contacto:
- Kamil Yamak, Professor
- Número de teléfono: +90 532 722 0852
- Correo electrónico: kamilyamak@hotmail.com
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Investigador principal:
- Kamil Yamak, Professor
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra de probabilidad
Población de estudio
The study population comprises adult patients aged 18 years and older, of both sexes, who have undergone primary hip arthroplasty (either total or partial) at participating multi-center orthopedic clinics.
The cohort specifically represents individuals whose surgical treatment involved the standard clinical implantation of the Tipmed™ Primary Hip Prosthesis System component options.
Eligible individuals who are legally competent and provide written informed consent to allow their routine post-operative clinical, laboratory, and radiographic data to be documented will be consecutively enrolled.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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).
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
Periodo de tiempo: 24 months post-operatively.
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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).
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24 months post-operatively.
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Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: From the signing of informed consent up to 24 months post-operatively.
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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.
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From the signing of informed consent up to 24 months post-operatively.
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Incidence of Clinical Complications
Periodo de tiempo: From the time of signing the informed consent form up to 24 months post-operatively.
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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.
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From the time of signing the informed consent form up to 24 months post-operatively.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS)
Periodo de tiempo: Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, 12, 18, and 24 months post-operatively.
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Periodic monitoring of absolute HHS tracking metrics and category shifts to determine the 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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Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, 12, 18, and 24 months post-operatively.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Ahmet Karakaşlı, Professor, Dokuz Eylul University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de marzo de 2024
Finalización primaria (Estimado)
31 de diciembre de 2028
Finalización del estudio (Estimado)
31 de marzo de 2029
Fechas de registro del estudio
Enviado por primera vez
4 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
1 de agosto de 2025
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- INFO TPMHIP P
- 2023-190 (Otro identificador: Turkish Medicines and Medical Devices Agency (TITCK))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual Participant Data (IPD) will not be shared publicly due to the strict confidentiality requirements, personal data protection legislation (KVKK Law No.6698), and commercial intellectual property rights policies of the sponsor.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Tipmed™ Primary Hip Prosthesis System
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Hip Innovation TechnologyReclutamientoArtrosis, Cadera | Necrosis avascular de cadera | Enfermedad degenerativa de las articulaciones | Artropatía Traumática-CaderaEstados Unidos