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

17 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™ 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

35

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 Onel, Sponsor Rep
  • Número de teléfono: +90 232 479 33 22
  • Correo electrónico: yaseminonel@tipmed.com

Ubicaciones de estudio

  • Turquía (Türkiye)
      • Balıkesir, Turquía (Türkiye), 10100
        • Reclutamiento
        • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
        • Contacto:
        • Investigador principal:
          • Özgün Karakuş, Professor
        • Sub-Investigador:
          • Fatih Işık, MD, Spec.
        • Sub-Investigador:
          • Fatih Palıt, MD, Spec.
        • Sub-Investigador:
          • Uğur Yüzügüldü, MD, Spec.
        • Sub-Investigador:
          • Mücahit Çelik, MD, Spec.
      • Balıkesir, Turquía (Türkiye), 10900
        • Reclutamiento
        • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
        • Contacto:
        • Investigador principal:
          • Cemal Aydın, MD, Spec.
      • Izmir, Turquía (Türkiye), 35330
        • Reclutamiento
        • Dokuz Eylül University Research and Application Hospital
        • Contacto:
        • Investigador principal:
          • Ahmet Karakaşlı, Professor
      • 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
        • Contacto:
        • Investigador principal:
          • Kamil Yamak, Professor

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 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.

Descripción

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.

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
Tıpmed™ Revision Hip Prosthesis
A single prospective, multi-center, non-interventional cohort of adult patients tracked during routine clinical practice who have undergone revision hip arthroplasty using the Tıpmed™ Revision Hip Prosthesis System. Patients are enrolled following revision surgery indicated for clinical complications such as aseptic loosening, periprosthetic infection, joint instability, dislocation, or periprosthetic fractures. The cohort captures real-world clinical data based on standard orthopedic indications without any study-mandated modifications to the routine surgical choice.
Dispositivo: Tıpmed™ Revision Hip Prosthesis System
Post-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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
Periodo de tiempo: 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 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).
24 months post-operatively
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.
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.
From the signing of informed consent up to 24 months post-operatively.
Incidence of Clinical Complications
Periodo de tiempo: From the time of signing the informed consent form up to 24 months post-operatively.
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.
From the time of signing the informed consent form up to 24 months post-operatively.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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.
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.
Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, 12, 18, and 24 months post-operatively.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

TIPMED Medical Device Manufacturing Ltd. Co.

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

11 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • INFO TPMHIP R
  • 2023-191 (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. .

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