Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yasemin Önel, Sponsor Rep
- Numéro de téléphone: +90 232 479 33 22
- E-mail: yaseminonel@tipmed.com
Lieux d'étude
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Balıkesir, Turquie (Türkiye), 10100
- Recrutement
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
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Contact:
- Özgün Karakuş, Professor
- Numéro de téléphone: +90 266 460 4000
- E-mail: ozgunkarakus@hotmail.com
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Chercheur principal:
- Özgün Karakuş, Professor
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Sous-enquêteur:
- Fatih Işık, MD, Spec.
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Sous-enquêteur:
- Fatih Palıt, MD, Spec.
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Sous-enquêteur:
- Uğur Yüzügüldü, MD, Spec.
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Sous-enquêteur:
- Mücahit Çelik, MD, Spec.
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Balıkesir, Turquie (Türkiye), 10900
- Recrutement
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
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Contact:
- Cemal Aydın, MD, Spec.
- Numéro de téléphone: +90 266 412 6999
- E-mail: cemalaydın80@hotmail.com
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Chercheur principal:
- Cemal Aydın, MD, Spec.
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Izmir, Turquie (Türkiye), 35330
- Recrutement
- Dokuz Eylul University Research and Application Hospital
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Contact:
- Ahmet Karakaşlı, Professor
- Numéro de téléphone: +90 (232) 412 22 22
- E-mail: karakasliahmet@gmail.com
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Chercheur principal:
- Ahmet Karakaşlı, Professor
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Izmir, Turquie (Türkiye), 35390
- Recrutement
- Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
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Contact:
- Kamil Yamak, Professor
- Numéro de téléphone: +90 532 722 0852
- E-mail: kamilyamak@hotmail.com
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Chercheur principal:
- Kamil Yamak, Professor
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
Délai: 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 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).
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24 months post-operatively
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Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: 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 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.
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From the signing of informed consent up to 24 months post-operatively.
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Incidence of Clinical Complications
Délai: 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 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.
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From the time of signing the informed consent form up to 24 months post-operatively.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS)
Délai: 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 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.
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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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Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Ahmet Karakaşlı, Professor, Dokuz Eylul University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- INFO TPMHIP R
- 2023-191 (Autre identifiant: Turkish Medicines and Medical Devices Agency (TITCK))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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