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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 comb
• Устройство 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 stu

Первичные конечные точки

• Functional Capacity Assessment via Modified Constant-Murley Score (MCMS) [Срок оценки: 12 months postoperatively]
• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to 12 months postoperatively]
• Incidence of Clinical Complications [Срок оценки: Up to 12 months postoperatively]

Вторичные конечные точки (2)

• Longitudinal Change in Functional Capacity via Modified Constant-Murley Score (MCMS) [Срок оценки: 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) [Срок оценки: Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, and 12 months post-operatively.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• Concurrent participation in any other interventional clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 4 центра

• Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk Ci — Balıkesir
• Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sult — Istanbul
• Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay Unive — Izmir
• Dokuz Eylül University Research and Application Hospital — Izmir

Идентификаторы

NCT: NCT07678034 · INFO TPMSP · 2024-199

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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