Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
調査の概要
状態
詳細な説明
This prospective, observational, PMCF study evaluates the short-to-medium-term safety and efficacy data of the Tipmed™ Primary Hip Prosthesis System in patients undergoing primary hip arthroplasty (total or partial) across 4 clinical centers in Turkey. A total of 101 eligible participants will be enrolled in accordance with the pre-defined inclusion and exclusion criteria. Pre-operative demographic details, medical history, and surgical parameters will be captured retrospectively from patient medical charts. Following the baseline 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 indicators. Clinical performance and joint functionality 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 (such as dislocation, aseptic loosening, or infection), and hardware deficiencies. Radiological findings (implant orientation, migration, osteointegration) and laboratory indicators (such as C-Reactive Protein and Sedimentation Rate) will be documented when available as part of standard medical surveillance.
Demographic characteristics, clinical parameters, and efficacy/safety outcomes will be summarized using descriptive statistics. Stratified analyses will be conducted based on the specific type of primary surgical intervention. Separate subgroup analyses will be executed for study participants who undergo partial hip arthroplasty (hemiarthroplasty) to isolate and evaluate their outcomes independently from the patients treated with total hip arthroplasty. Categorical variables across these subgroups will be compared using the Chi-square test or Fisher's exact test, as appropriate.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Yasemin Önel, Sponsor Rep
- 電話番号：+90 232 479 33 22
- メール：yaseminonel@tipmed.com
研究場所
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Balıkesir、トルコ（Türkiye）、10100
- 募集
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
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コンタクト：
- Özgün Karakuş, Professor
- 電話番号：+90 266 460 4000
- メール：ozgunkarakus@hotmail.com
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主任研究者：
- Özgün Karakuş, Professor
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副調査官：
- fatih Işık, MD, Spec.
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副調査官：
- Fatih Palıt, MD, Spec.
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副調査官：
- Uğur Yüzügüldü, MD, Spec.
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副調査官：
- Mücahit Çelik, MD, Spec.
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Balıkesir、トルコ（Türkiye）、10700
- 募集
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
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コンタクト：
- Cemal Aydın, MD, Spec.
- 電話番号：+90 266 412 6999
- メール：cemalaydın80@hotmail.com
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主任研究者：
- Cemal Aydın, MD, Spec.
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Izmir、トルコ（Türkiye）、35330
- 募集
- Dokuz Eylül University Research and Application Hospital
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コンタクト：
- Ahmet Karakaşlı, Professor
- 電話番号：+90 (232) 412 22 22
- メール：karakasliahmet@gmail.com
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主任研究者：
- Ahmet Karakaşlı, Professor
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Izmir、トルコ（Türkiye）、35390
- 募集
- Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
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コンタクト：
- Kamil Yamak, Professor
- 電話番号：+90 532 722 0852
- メール：kamilyamak@hotmail.com
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主任研究者：
- Kamil Yamak, Professor
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Individuals aged 18 years and older,
- Male or female participants,
- Subjects who have undergone Primary Hip Arthroplasty (either total or partial) for any indication,
- Subjects in whose surgical procedure the Tipmed™ Primary Hip Prosthesis System components were utilized.
- Subjects who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship).
- Subjects who have voluntarily signed the written Informed Consent Form (ICF).
Exclusion Criteria:
- Subjects currently participating in any other interventional clinical trial.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Tipmed™ Primary Hip Prosthesis
A single prospective cohort of adult patients tracked during routine clinical practice who have undergone primary hip arthroplasty (either total hip arthroplasty or partial hemiarthroplasty) using the Tipmed™ Primary Hip Prosthesis System (including cemented or uncemented stem options based on standard surgical indications).
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Post-market utilization of the commercially available Tipmed™ Primary Hip Prosthesis System during routine orthopedic care.
Device components include various configurations such as cemented or uncemented stems (anatomic or square cross-section), acetabular cups, bipolar cups, and titanium metal shells fitted according to standard clinical routine and patient anatomy.
No investigational or non-routine interventions are performed as part of this observational registry.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
時間枠：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.
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)
時間枠：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 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.
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From the signing of informed consent up to 24 months post-operatively.
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Incidence of Clinical Complications
時間枠：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 complications recorded throughout the study period.
This includes intraoperative complications captured retrospectively from surgical medical records (such as femoral or acetabular fractures, vascular injuries, and nerve lesions) as well as longitudinal complications documented during the follow-up phase (such as joint dislocation, aseptic loosening, implant breakage, or deep and superficial surgical site infections) associated with the routine clinical utilization of the Tipmed™ Primary 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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS)
時間枠：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 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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協力者と研究者
捜査官
- スタディディレクター：Ahmet Karakaşlı, Professor、Dokuz Eylul University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- INFO TPMHIP P
- 2023-190 (その他の識別子：Turkish Medicines and Medical Devices Agency (TITCK))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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Tipmed™ Primary Hip Prosthesis Systemの臨床試験
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Hip Innovation Technology募集