Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents
Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires Versus Plate Fixation in the Treatment of Distal Tibial Metaphyseal-diaphyseal Junction Fractures in Adolescents
調査の概要
状態
詳細な説明
Distal tibial metaphyseal-diaphyseal junction fractures in adolescents can be difficult to treat because of the short distal fragment, proximity to the growth plate, and tendency toward displacement and malalignment. Elastic stable intramedullary nailing is minimally invasive and preserves the fracture biology, but fixation of the short distal fragment may be less stable. Supplementary Kirschner wires may improve rotational and angular stability. Plate fixation provides stable fixation and good control of alignment but may require greater soft-tissue dissection.
This study will be conducted at the Department of Orthopaedics Surgery, Sohag University Hospital. Eligible adolescents with displaced or unstable distal tibial metaphyseal-diaphyseal junction fractures requiring surgical fixation will be randomly assigned to one of two treatment groups. Group A will undergo elastic stable intramedullary nailing supplemented by one or two Kirschner wires. Group B will undergo plate fixation using a distal tibial locking compression plate. Randomization will be performed using a computer-generated sequence in a 1:1 ratio.
Patients will undergo clinical and radiological follow-up at 2 weeks, 6 weeks, 3 months, and 6 months. The primary outcomes are time to radiological union and fracture union rate. Secondary outcomes include coronal and sagittal alignment, time to full weight-bearing, AOFAS Ankle-Hindfoot Score, Lower Extremity Functional Scale, and complications including malunion, delayed union, nonunion, infection, implant irritation or failure, and reoperation.
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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Sohag Governorate
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Sohag、Sohag Governorate、エジプト、82749
- 募集
- Sohag university hospital
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コンタクト：
- Mohamed S Hassan, M.B.B.Ch.
- 電話番号：01060318567
- メール：mohamed.farghaly@med.sohag.edu.eg
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コンタクト：
- Sumayya M Mohamed, M.B.B.Ch.
- 電話番号：01016571202
- メール：su5221225@gmail.com
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 10-16 years.
- Patients diagnosed with distal tibial metaphyseal-diaphyseal junction (DTDMJ) fractures.
- Closed fractures or Gustilo-Anderson type I open fractures.
- Acute fractures presenting within two weeks of injury.
- Displaced or unstable fractures requiring surgical fixation.
- Open or partially open physis, as assessed on preoperative radiographs.
Exclusion Criteria:
- Patients younger than 10 years or older than 16 years.
- Fractures involving the distal tibial physis (Salter-Harris fractures).
- Intra-articular distal tibial fractures.
- Gustilo-Anderson type II and III open fractures.
- Pathological fractures.
- Fractures associated with metabolic bone disease or congenital skeletal disorders.
- Polytrauma patients requiring alternative treatment priorities.
- Previous fracture, deformity, or surgical intervention involving the affected tibia.
- Neurovascular injury requiring repair.
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：ランダム化
- 介入モデル：並列代入
- 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：ESIN Supplemented by Kirschner Wires
Participants assigned to this arm will undergo elastic stable intramedullary nailing using two appropriately sized elastic titanium nails inserted through medial and lateral proximal tibial metaphyseal entry points.
One or two supplementary Kirschner wires will then be inserted percutaneously across the distal fragment under fluoroscopic guidance to improve rotational and angular stability.
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Closed reduction will be performed under fluoroscopic guidance.
Two appropriately sized titanium elastic nails will be inserted through medial and lateral entry points in the proximal tibial metaphysis and advanced across the fracture into the distal fragment.
One or two supplementary Kirschner wires will then be inserted percutaneously across the distal fragment under fluoroscopic guidance to enhance rotational and angular stability.
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アクティブコンパレータ：Plate Fixation
Participants assigned to this arm will undergo fixation with a distal tibial locking compression plate using a minimally invasive plate osteosynthesis technique or a limited open approach according to fracture characteristics.
The plate will be positioned on the medial aspect of the tibia and fixed with appropriate locking and cortical screws under fluoroscopic guidance.
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Following fracture reduction, fixation will be performed using a distal tibial locking compression plate through a minimally invasive plate osteosynthesis technique or a limited open approach according to fracture characteristics.
The plate will be positioned on the medial aspect of the tibia and secured with appropriate locking and cortical screws under fluoroscopic guidance.
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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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Time to Radiological Union
時間枠：From surgery through 6 months
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Time from surgery to radiographic evidence of fracture union as assessed on follow-up anteroposterior and lateral radiographs.
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From surgery through 6 months
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Fracture Union Rate
時間枠：At 6 months
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Proportion of participants demonstrating radiological fracture union during postoperative follow-up.
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At 6 months
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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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Coronal and Sagittal Alignment
時間枠：At 2 weeks, 6 weeks, 3 months, and 6 months
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Radiographic assessment of coronal and sagittal alignment of the distal tibia during postoperative follow-up.
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At 2 weeks, 6 weeks, 3 months, and 6 months
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AOFAS Ankle-Hindfoot Score
時間枠：During postoperative follow-up through 6 months
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Functional outcome assessed using the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score.
The total score ranges from 0 to 100 points, including pain, function, and alignment, with higher scores indicating better outcome.
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During postoperative follow-up through 6 months
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Lower Extremity Functional Scale
時間枠：During postoperative follow-up through 6 months
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Functional outcome assessed using the Lower Extremity Functional Scale (LEFS), a patient-reported measure evaluating difficulty with daily activities such as walking, running, and climbing stairs.
The maximum score is 80 points, with higher scores indicating better lower-extremity function.
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During postoperative follow-up through 6 months
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Treatment-Related Complication Rate
時間枠：From surgery through 6 months
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Proportion of participants experiencing treatment-related complications, including malunion, delayed union, nonunion, superficial infection, deep infection, implant irritation, implant failure, or reoperation.
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From surgery through 6 months
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Time to Full Weight-Bearing
時間枠：From surgery through 6 months
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Time from surgery until the participant is allowed to progress to full weight-bearing based on fracture stability and radiographic evidence of healing.
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From surgery through 6 months
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協力者と研究者
スポンサー
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
- SOH-MED-2026-001
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