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

2026년 6월 24일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

54

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 터키 (Türkiye)
      • Balıkesir, 터키 (Türkiye), 10100
        • 모병
        • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
        • 연락하다:
        • 수석 연구원:
          • Özgün Karakuş, Assoc. Prof.
        • 부수사관:
          • Murat Gök, MD, Spec.
      • Istanbul, 터키 (Türkiye), 34303
        • 아직 모집하지 않음
        • Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital
        • 연락하다:
        • 수석 연구원:
          • Oğuzhan Bulut, MD, Spec.
      • Izmir, 터키 (Türkiye), 35140
        • 아직 모집하지 않음
        • Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital
        • 연락하다:
        • 수석 연구원:
          • Sercan Çapkın, MD, Spec.
        • 부수사관:
          • Murat Kaan Atalay, MD, Spec.
      • Izmir, 터키 (Türkiye), 35340
        • 아직 모집하지 않음
        • Dokuz Eylul University Research and Application Hospital
        • 연락하다:
        • 수석 연구원:
          • Onur Başçı, Assoc. Prof.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
장치: 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
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Functional Capacity Assessment via Modified Constant-Murley Score (MCMS)
기간: 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)
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Longitudinal Change in Functional Capacity via Modified Constant-Murley Score (MCMS)
기간: 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)
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

TIPMED Medical Device Manufacturing Ltd. Co.

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 6월 16일

기본 완료 (추정된)

2030년 3월 15일

연구 완료 (추정된)

2030년 6월 15일

연구 등록 날짜

최초 제출

2026년 6월 24일

QC 기준을 충족하는 최초 제출

2026년 6월 24일

처음 게시됨 (실제)

2026년 7월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 24일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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위치

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