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

11 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

35

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
      • Balıkesir, Turchia (Türkiye), 10100
        • Reclutamento
        • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
        • Contatto:
        • Investigatore principale:
          • Özgün Karakuş, Professor
        • Sub-investigatore:
          • Fatih Işık, MD, Spec.
        • Sub-investigatore:
          • Fatih Palıt, MD, Spec.
        • Sub-investigatore:
          • Uğur Yüzügüldü, MD, Spec.
        • Sub-investigatore:
          • Mücahit Çelik, MD, Spec.
      • Balıkesir, Turchia (Türkiye), 10900
        • Reclutamento
        • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
        • Contatto:
        • Investigatore principale:
          • Cemal Aydın, MD, Spec.
      • Izmir, Turchia (Türkiye), 35330
        • Reclutamento
        • Dokuz Eylül University Research and Application Hospital
        • Contatto:
        • Investigatore principale:
          • Ahmet Karakaşlı, Professor
      • Izmir, Turchia (Türkiye), 35390
        • Reclutamento
        • Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
        • Contatto:
        • Investigatore principale:
          • Kamil Yamak, Professor

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

TIPMED Medical Device Manufacturing Ltd. Co.

Investigatori

  • Direttore dello studio: Ahmet Karakaşlı, Professor, Dokuz Eylul University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 marzo 2024

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 marzo 2029

Date di iscrizione allo studio

Primo inviato

11 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • INFO TPMHIP R
  • 2023-191 (Altro identificatore: Turkish Medicines and Medical Devices Agency (TITCK))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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