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

10 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

101

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Turkije (Türkiye)
      • Balıkesir, Turkije (Türkiye), 10100
        • Werving
        • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Özgün Karakuş, Professor
        • Onderonderzoeker:
          • Fatih Işık, MD, Spec.
        • Onderonderzoeker:
          • Fatih Palıt, MD, Spec.
        • Onderonderzoeker:
          • Uğur Yüzügüldü, MD, Spec.
        • Onderonderzoeker:
          • Mücahit Çelik, MD, Spec.
      • Balıkesir, Turkije (Türkiye), 10700
        • Werving
        • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Cemal Aydın, MD, Spec.
      • Izmir, Turkije (Türkiye), 35330
        • Werving
        • Dokuz Eylul University Research and Application Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Ahmet Karakaşlı, Professor
      • Izmir, Turkije (Türkiye), 35390
        • Werving
        • Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Kamil Yamak, Professor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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).
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS)
Tijdsspanne: 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 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

TIPMED Medical Device Manufacturing Ltd. Co.

Onderzoekers

  • Studie directeur: Ahmet Karakaşlı, Professor, Dokuz Eylul University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 maart 2024

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 maart 2029

Studieregistratiedata

Eerst ingediend

4 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2026

Eerst geplaatst (Werkelijk)

16 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juni 2026

Laatst geverifieerd

1 augustus 2025

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • INFO TPMHIP P
  • 2023-190 (Andere identificatie: Turkish Medicines and Medical Devices Agency (TITCK))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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