Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures
Accuracy of Positioning Guide and Customized Titanium Plate for Reduction and Fixation of Zygomaticomaxillary Complex Fracture: A Case Series
The goal of this clinical trial is to evaluate the accuracy and stability of positioning guides and customized titanium plates in the treatment of Zygomaticomaxillary Complex (ZMC) fractures. The main questions it aims to answer are:
- Is the anatomical reduction achieved using a virtual planning-based positioning guide accurate when compared to preoperative plans?
- Does the customized titanium plate provide stable fixation during the follow-up period?
Researchers will compare the actual postoperative outcome to the preoperative virtual surgical plan to see if the customized workflow improves anatomical alignment.
Participants will:
- Undergo a preoperative Computed Tomography (CT) scan for virtual surgical planning.
- Receive surgical treatment using a patient-specific positioning guide and customized titanium plate.
- Complete follow-up assessments including postoperative CT scans and clinical evaluations for 6 months.
調査の概要
状態
詳細な説明
The clinical workflow for managing unilateral Zygomaticomaxillary Complex (ZMC) fractures begins with a standardized diagnostic phase. Patients undergo a thorough medical and dental history followed by a comprehensive clinical examination. A high-resolution preoperative Computed Tomography (CT) scan (T0) is acquired within one week prior to the intervention to visualize fracture patterns and the extent of displacement. The Digital Imaging and Communications in Medicine (DICOM) data is imported into specialized medical imaging software, such as Materialise Mimics or 3-matic, for three-dimensional (3D) reconstruction and Virtual Surgical Planning (VSP).
During the digital planning phase, the fractured zygomaticomaxillary complex is virtually reduced by mirroring the unaffected contralateral side to achieve optimal anatomical symmetry. Based on this virtual model, a patient-specific positioning guide is designed to fit the bone surface and indicate exact locations for plate and screw placement. Simultaneously, a customized titanium plate is designed to conform perfectly to the reduced bone contours, incorporating optimal screw hole positions to maximize stability and avoid vital structures. These plates are fabricated using additive manufacturing techniques, specifically selective laser melting, to ensure high precision and biocompatibility.
The surgical procedure is performed under general anesthesia. Appropriate surgical approaches, including lateral eyebrow and intraoral vestibular incisions, are used to expose the fracture site. The positioning guide is utilized to facilitate the accurate relocation of ZMC fragments according to the preoperative virtual plan. Once the fracture is accurately reduced, the custom-made titanium plate is adapted to the bone surface and secured with screws to achieve rigid internal fixation, minimizing the need for intraoperative plate bending.
Postoperative care includes an immediate follow-up Computed Tomography (CT) scan (T1) within 1 to 3 days to assess the accuracy of fracture reduction and plate placement by superimposing the postoperative actual model onto the preoperative virtual plan. Clinical follow-up occurs at regular intervals (1 week, 1 month, 3 months, 6 months, and 1 year) to assess wound healing, facial symmetry, ocular function, and mouth opening. A long-term follow-up CT scan (T2) is obtained at 6 months to evaluate bone healing and the long-term stability of the fixation.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Cairo、エジプト
- department of oral and maxillofacial surgery, faculty of dentistry, Cairo university
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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
説明
Inclusion Criteria:
- Patients diagnosed with Zygomatico-maxillary complex fractures requiring surgical intervention.
- Patients aged 18 years or older.
- Patients willing to provide informed consent and comply with follow-up protocols.
- Patients with adequate bone quality and quantity for stable fixation.
Exclusion Criteria:
- Patients with comminuted ZMC fractures that preclude the use of custom-made guides based on mirroring the contra lateral side.
- Patients with pre-existing facial deformities or asymmetries that would interfere with accurate assessment of fracture reduction.
- Patients with systemic diseases or conditions that contraindicate elective surgery or impair bone healing (e.g., uncontrolled diabetes, severe osteoporosis, active malignancy, and immunosuppression).
- Patients on medications affecting bone metabolism (e.g., long-term corticosteroids, bisphosphonates). Patients with active infections in the maxillofacial region.
- Pregnant or lactating women.
- Patients with psychiatric disorders or unrealistic expectations.
- Patients who are unable to undergo CT scans or follow post-operative instructions.
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
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Virtual Planning and Customized Plates
Patients with ZMC fractures undergoing surgical treatment using 3D virtual planning and patient-specific titanium plates.
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A 3D-printed positioning guide designed through virtual surgical planning to assist in the accurate reduction of ZMC fractures.
A custom-fabricated titanium plate designed to fit the patient's specific anatomy for rigid fixation of ZMC fractures.
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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 |
|---|---|---|
|
Accuracy of Fracture Reduction
時間枠：one week postoperative
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Evaluation of the accuracy of fracture reduction achieved using the positioning guide and customized titanium plate.
This will be assessed by superimposing the post-operative computed tomography (CT) scans onto the pre-operative virtual surgical plan.
The difference will be reported as linear deviation, measured in millimeters (mm).
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one week postoperative
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Assessment of Facial Symmetry (Malar Projection)
時間枠：6 months postoperatively
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Evaluation of aesthetic outcome and facial symmetry by assessing the malar projection.
This will be measured clinically or via imaging (e.g., comparing the fractured side to the intact side).
The outcome will be reported as the linear discrepancy or difference between the two sides, measured in millimeters (mm).
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6 months postoperatively
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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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Assessment of Ocular Motility and Diplopia
時間枠：6 months postoperatively
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Clinical assessment of functional recovery regarding ocular motility.
Patients will be clinically examined for the presence or absence of diplopia (double vision) in different fields of gaze.
The outcome will be reported as a categorical variable (e.g., Presence / Absence of diplopia).
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6 months postoperatively
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Total Operative Time
時間枠：Day of surgery (Intraoperative)
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The total duration of the surgical procedure measured in minutes, from the initial incision to the final closure.
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Day of surgery (Intraoperative)
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Patient Satisfaction
時間枠：6 months postoperatively
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Evaluation of the patient's overall satisfaction with the functional and aesthetic outcomes of the procedure.
This will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates "completely dissatisfied" and 10 indicates "completely satisfied".
The reported value will be the numerical score on this scale.
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6 months postoperatively
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Prof. Ramy Ragab Elbialy, prof. of maxillofacial surgery、Department of Oral and maxillofacial surgery,Faculty of dentistry, Cairo university
- スタディディレクター：Dr. Mohamed Ali Zain Elabden, lecturer of maxillofacial surg、department of oral and maxillofacial surgery, faculty of dentistry, Cairo 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
キーワード
その他の研究ID番号
- OMFS3319
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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