Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

24 czerwca 2026 zaktualizowane przez: TIPMED Medical Device Manufacturing Ltd. Co.

A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System

This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively. The study population includes adult patients who undergo reverse shoulder arthroplasty (RSA) or shoulder hemiarthroplasty (HA) using the Tipmed™ implant systems due to various clinical indications such as osteoarthritis, rotator cuff arthropathy, or proximal humerus fractures. The main objective is to gather real-world clinical evidence on the 12-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

The European Medical Device Regulation (MDR 2017/745) and corresponding national regulations dictate that additional safety and performance data must be systematically collected for CE-marked medical devices commercialized in the market. This clinical follow-up trial focuses on patients who are treated within routine medical practice, meaning no intervention or clinical assessment outside of standard scientific guidelines is forced upon the participants. Data regarding the preoperative status and operative details will be collected retrospectively from patient medical charts. Postoperative data will be gathered prospectively through regular follow-up visits scheduled at the 6th week, 3rd month, 6th month, and 12th month. Functional performance will be objectively quantified using the Modified Constant-Murley Score (MCMS). Quality of life metrics will be assessed via the Short Form-12 (SF-12) questionnaire. Safety reporting will encompass the continuous tracking and recording of all Adverse Events (AEs), Serious Adverse Events (SAEs), and specific device-related orthopedic complications (e.g., aseptic loosening, infection, dislocation, and scapular notch formation) over the complete 12-month postoperative follow-up period. Statistical comparisons will be managed separately for the two distinct treatment cohorts: the Reverse Shoulder Arthroplasty cohort and the Hemiarthroplasty cohort.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

54

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Turcja (Türkiye)
      • Balıkesir, Turcja (Türkiye), 10100
        • Rekrutacyjny
        • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
        • Kontakt:
        • Główny śledczy:
          • Özgün Karakuş, Assoc. Prof.
        • Pod-śledczy:
          • Murat Gök, MD, Spec.
      • Istanbul, Turcja (Türkiye), 34303
        • Jeszcze nie rekrutacja
        • Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital
        • Kontakt:
        • Główny śledczy:
          • Oğuzhan Bulut, MD, Spec.
      • Izmir, Turcja (Türkiye), 35140
        • Jeszcze nie rekrutacja
        • Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital
        • Kontakt:
        • Główny śledczy:
          • Sercan Çapkın, MD, Spec.
        • Pod-śledczy:
          • Murat Kaan Atalay, MD, Spec.
      • Izmir, Turcja (Türkiye), 35340
        • Jeszcze nie rekrutacja
        • Dokuz Eylül University Research and Application Hospital
        • Kontakt:
        • Główny śledczy:
          • Onur Başçı, Assoc. Prof.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

The study population comprises adult patients aged 18 years and older, of both sexes, who have undergone either reverse shoulder arthroplasty or shoulder hemiarthroplasty at the participating multi-center orthopedic clinics. The study population is stratified into two distinct clinical cohorts representing individuals whose surgical treatment involved the standard clinical implantation of the Tipmed™ Shoulder Prosthesis System component options under specific anatomical configurations. Eligible individuals who are legally competent and provide written informed consent to allow their routine clinical findings to be documented for the study will be consecutively enrolled.

Opis

Inclusion Criteria:

  • Individuals aged 18 years and older,
  • Male or female participants,
  • Participants who have undergone Reverse Shoulder Arthroplasty or Shoulder Hemiarthroplasty for any valid indication,
  • Participants in whose surgical procedure the Tipmed™ Shoulder Prosthesis System product configurations 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:

  • Concurrent participation in any other interventional clinical trial.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Reverse Shoulder Arthroplasty (RSA) Cohort
Patients who undergo reverse shoulder arthroplasty using the Tipmed™ Reverse Shoulder Prosthesis System components (including Humeral Stem, Humeral Tray, Humeral Cup, Glenosphere, Baseplate, and Screws). Target enrollment: 40 participants.
Urządzenie: Tipmed™ Reverse Shoulder Prosthesis System
Prospective clinical follow-up and observational data collection for adult patients who have already undergone reverse shoulder arthroplasty using the CE-marked Tipmed™ Reverse Shoulder Prosthesis System in routine clinical practice. Since participants are enrolled postoperatively, the intervention does not involve any experimental surgical assignment. No investigational or nonroutine interventions are performed as part of this observational registry. The tracked device components include a combination of humeral stems available in various dimensional configurations, humeral trays, ultra-high molecular weight polyethylene (UHMWPE) humeral cups, glenospheres, and porous + hydroxyapatite (HA)-coated baseplates with locking or non-locking fixation screws, which were tailored intraoperatively during the index surgery according to the participant's specific shoulder anatomy and bone quality.
Shoulder Hemiarthroplasty (HA) Cohort
Patients who undergo shoulder hemiarthroplasty involving isolated replacement of the humeral head, using Tipmed™ Humeral Stems and Modular Humeral Heads interacting with the patient's natural glenoid. Target enrollment: 14 participants
Urządzenie: Tipmed™ Shoulder Prosthesis System (Hemiarthroplasty Configuration)
Prospective clinical follow-up and observational data collection for adult patients who have already undergone shoulder hemiarthroplasty surgery utilizing specific components of the CE-marked Tipmed™ Shoulder Prosthesis System in routine clinical practice. Since participants are enrolled postoperatively, this observational study does not involve any active or experimental surgical intervention assigned by the protocol. No investigational or nonroutine procedures are performed as part of this study. The tracked intervention evaluates the post-surgical performance of the explicitly isolated replacement of the humeral head interacting with the patient's natural glenoid fossa. Observational data tracking focuses on the implanted configuration consisting of a modular humeral stem paired with a modular humeral head connected via a tapered conical assembly, which were selected and tailored intraoperatively during the prior surgery based on patient-specific anatomical requirements.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Functional Capacity Assessment via Modified Constant-Murley Score (MCMS)
Ramy czasowe: 12 months postoperatively
The proportion of participants achieving "excellent" (90-100 points) or "good" (80-89 points) functional outcomes based on the total MCMS score. The MCMS evaluates shoulder function across four domains: pain (15 points), activities of daily living (20 points), active range of motion (40 points), and strength (25 points). The total score ranges from 0 to 100, where higher scores indicate better functional capacity and superior clinical outcomes.
12 months postoperatively
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Ramy czasowe: Up to 12 months postoperatively
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.
Up to 12 months postoperatively
Incidence of Clinical Complications
Ramy czasowe: Up to 12 months postoperatively
Evaluation of the rate, frequency, and types of all clinical complications recorded throughout the 12-month study period. This assessment includes intraoperative complications captured retrospectively from surgical medical records (such as humeral or glenoid fractures, vascular injuries, and nerve lesions) as well as longitudinal complications documented prospectively during the postoperative follow-up phase (such as joint dislocation, component loosening, implant breakage, scapular notching, osteolysis, or deep and superficial surgical site infections) associated with the routine clinical utilization of the Tipmed™ Shoulder Prosthesis System.
Up to 12 months postoperatively

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Longitudinal Change in Functional Capacity via Modified Constant-Murley Score (MCMS)
Ramy czasowe: Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, and 12 months post-operatively.
Evaluation of the chronological change and improvement in shoulder functional capacity from baseline (preoperative status) across all postoperative follow-up intervals. Total MCMS scores (0-100 points) will be tracked to capture the transition rates between functional categories: Excellent (90-100), Good (80-89), Fair (70-79), and Poor (<70). Higher scores reflect progressive functional recovery.
Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, and 12 months post-operatively.
Change in Quality of Life via Short Form-12 (SF-12)
Ramy czasowe: Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, and 12 months post-operatively.
Evaluation of the change in health-related quality of life from baseline across all postoperative follow-up points. The SF-12 is a generic instrument assessing eight dimensions of health status across physical and mental components. Each subscale is transformed and scored from 0 to 100, where 0 represents the worst health state and 100 represents the optimal health state. Higher values indicate a superior quality of life.
Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, and 12 months post-operatively.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

TIPMED Medical Device Manufacturing Ltd. Co.

Śledczy

  • Dyrektor Studium: Özgün Karakuş, Assoc. Prof., Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate, Atatürk City Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

16 czerwca 2025

Zakończenie podstawowe (Szacowany)

15 marca 2030

Ukończenie studiów (Szacowany)

15 czerwca 2030

Daty rejestracji na studia

Pierwszy przesłany

24 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

1 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • INFO TPMSP
  • 2024-199 (Inny identyfikator: Turkish Medicines and Medical Devices Agency (TITCK))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Nigeria

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
Subskrybuj