Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Which One ?
2026年4月26日 更新者：Ebraheem Ahmed Farouk Abdelraheem、Assiut University
Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Randomized Controlled Trial
The primary aim of this research is to compare the efficacy of conservative treatment versus surgical treatment for Gartland type II supracondylar humerus fractures in children.
The comparison focuses on assessing differences in clinical outcomes functional recovery times, and complication rates between the two treatment groups.
調査の概要
状態
まだ募集していません
条件
詳細な説明
Supracondylar Humerus Fractures are the most common type of elbow fracture in children, typically occurring between the ages of five and seven. These injuries are critical due to their proximity to major neurovascular structures, making prompt and appropriate management essential to prevent severe complications. The vast majority (approximately 98%) of SCHFs are extension-type injuries, resulting from a fall onto an outstretched hand with the elbow hyperextended.
Classification: The Gartland System The classification is based on the degree of displacement of the distal fragment relative to the proximal fragment, as seen on a lateral radiograph.
Type I stable, nondisplaced fractures are managed non-operatively.
- Treatment: Immobilization in a long-arm cast or splint for 3 to 4 weeks, typically in 90 degrees of flexion, followed by early mobilization .
- Goal: Pain control and protection from further displacement. Type II FracturesThese fractures are unstable in extension but maintain some stability due to the intact posterior cortex. Management remains a point of controversy, with both conservative and surgical options being utilized.•Conservative Option: Closed reduction (CR) and casting, often reserved for less displaced or stable Type IIA fractures.•Surgical Option: Closed Reduction and Percutaneous Pinning (CRPP) is the preferred surgical method, especially for unstable Type IIB fractures (those with rotational instability).
Type III and IV are highly unstable fractures that require urgent intervention to achieve and maintain reduction .
Treatment: Closed Reduction and Percutaneous Pinning (CRPP) is the mainstay of treatment .Open reduction may be necessary if closed reduction fails or if there is a vascular compromise requiring exploration.
•Goal: Anatomical reduction and stable fixation to prevent malunion and neurovascular complications.
研究の種類
介入
入学 (推定)
50
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Patients with Gartland type II supracondylar humerus fractures with age between 1-12 years old treated at the AUH
Exclusion Criteria:
- Gartland Type I, III, or IV fractures.
- Open fractures.
- Associated neurovascular injury (e.g., absent radial pulse, documented nerve palsy).
- Patients with another injury in the same limb
- Pathological fractures.
- Pre-existing elbow pathology or congenital deformity.
- Inability to comply with follow-up protocol.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：Conservative treatment
Children with Gartland type II supracondylar humeral fractures will be treated conservatively using closed reduction followed by immobilization in an above-elbow cast .
Patients will be followed up clinically and radiologically at regular intervals to assess fracture alignment, healing, and functional outcomes.
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Closed reduction of Gartland type II supracondylar humeral fracture under appropriate analgesia or anesthesia, followed by immobilization using an above-elbow cast.
Patients will undergo regular clinical and radiographic follow-up to monitor fracture alignment, healing, and functional recovery.
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実験的：Surgical treatment group
Children will undergo surgical treatment via Closed reduction and percutaneous pinning under general anesthesia.
Postoperative follow-up will include clinical and radiological assessment of fracture healing, alignment, and complications.
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surgical treatment vis Closed reduction and percutaneous pinning under general anesthesia.
Postoperative care includes clinical and radiographic follow-up to assess fracture healing, alignment, and potential complications.
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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 outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
時間枠：1 year
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Functional outcome will be evaluated using the Modified QuickDASH questionnaire.
Scores range from 0 to 100, with higher scores indicating greater disability.
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1 year
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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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Elbow flexion range of motion (degrees)
時間枠：1 month, 3 months, and 6 months post-intervention
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Measured in degrees using a goniometer to assess maximum elbow flexion.
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1 month, 3 months, and 6 months post-intervention
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Elbow extension range of motion (degrees)
時間枠：1 month, 3 months, and 6 months post-intervention
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Measured in degrees using a goniometer to assess maximum elbow extension.
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1 month, 3 months, and 6 months post-intervention
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Pain assessed using Visual Analog Scale (VAS)
時間枠：1 month, 3 months, and 6 months post-intervention
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Pain is measured on a scale from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.
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1 month, 3 months, and 6 months post-intervention
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Baumann angle (degrees)
時間枠：Immediately post-reduction and at 6 months
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Measured on standard anteroposterior elbow radiographs to assess coronal alignment.
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Immediately post-reduction and at 6 months
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Anterior humeral line alignment (normal/abnormal)
時間枠：Immediately post-reduction and at 6 months
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Assessed on lateral elbow radiographs to evaluate sagittal alignment.
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Immediately post-reduction and at 6 months
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Loss of reduction (yes/no)
時間枠：Up to 6 months post-intervention
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Defined as displacement of fracture fragments on follow-up radiographs.
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Up to 6 months post-intervention
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Incidence of nerve injury (yes/no)
時間枠：Up to 6 months post-intervention
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Includes any documented motor or sensory nerve deficit following treatment.
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Up to 6 months post-intervention
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Incidence of infection (yes/no)
時間枠：Up to 6 months post-intervention
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Includes superficial or deep infection related to treatment.
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Up to 6 months post-intervention
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スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2028年6月1日
研究の完了 (推定)
2028年8月1日
試験登録日
最初に提出
2026年4月18日
QC基準を満たした最初の提出物
2026年4月26日
最初の投稿 (実際)
2026年4月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年4月30日
QC基準を満たした最後の更新が送信されました
2026年4月26日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。