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

24 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™ 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

54

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, Assoc. Prof.
        • Sub-investigatore:
          • Murat Gök, MD, Spec.
      • Istanbul, Turchia (Türkiye), 34303
        • Non ancora reclutamento
        • Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital
        • Contatto:
        • Investigatore principale:
          • Oğuzhan Bulut, MD, Spec.
      • Izmir, Turchia (Türkiye), 35140
        • Non ancora reclutamento
        • Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital
        • Contatto:
        • Investigatore principale:
          • Sercan Çapkın, MD, Spec.
        • Sub-investigatore:
          • Murat Kaan Atalay, MD, Spec.
      • Izmir, Turchia (Türkiye), 35340
        • Non ancora reclutamento
        • Dokuz Eylül University Research and Application Hospital
        • Contatto:
        • Investigatore principale:
          • Onur Başçı, Assoc. Prof.

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 non probabilistico

Popolazione di studio

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.

Descrizione

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.

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
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.
Dispositivo: 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
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional Capacity Assessment via Modified Constant-Murley Score (MCMS)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Longitudinal Change in Functional Capacity via Modified Constant-Murley Score (MCMS)
Lasso di tempo: 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)
Lasso di tempo: 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.

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

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)

16 giugno 2025

Completamento primario (Stimato)

15 marzo 2030

Completamento dello studio (Stimato)

15 giugno 2030

Date di iscrizione allo studio

Primo inviato

24 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2026

Primo Inserito (Effettivo)

1 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 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 TPMSP
  • 2024-199 (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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