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临床试验/NCT07207447
NCT07207447已完成不适用

Validity of the Non-union Scoring System in Management of Long Bone Fracture Non-union: A Prospective Study

Ain Shams University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月10日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Radiological Fracture Union

研究概览

简要总结

The aim of this study is to apply Calori Non union Scoring System on long bone non-union cases and evaluate the results of treatment o f the patients according to the score.

详细描述

The aim of this study is to apply Calori Non union Scoring System on long bone non-union cases and evaluate the results of treatment o f the patients according to the score. The study will be on patients with lower limb long bone diaphyseal fracture non-union. All patients will be assessed preoperatively by Clinical Evaluation: History, general examination, local examination, radiological evaluation: Plain X-ray films showing joint above and joint below the non-union site, laboratory Investigations: CBC, ESR, CRP and HbA1c. For patient allocation, patients will be divided into four groups according to the NUSS score, with group one (0-25 points) who underwent improving the stability and re-fixation with different modalities such as exchange plate with longer plate, intramedullary nailing, exchange nailing with larger diameter, plating over nail or dynamization of intramedullary nail. Group two (26-50 points) underwent re-fixation in addition to biological stimulation such as bone grafting, either with plate and bone graft, plate over nail and graft, or with external fixation with LRS or Ilizarov and grafting in one stage or two stages. Group three (51-75 points) required more complex care with resection of the non-union and dealing with the defect with bone transport, either direct transport or staged with cement spacer and later bone transport, Masquelet technique or acute compression and lengthening with another osteotomy. Group four (76-100 points) underwent amputation with consideration of prosthesis. The patients will be followed up at regular intervals as regard radiological and clinical evaluation until full union is achieved or non-union is established. The assessment includes; clinical and functional assessment based on pain at the fracture site and recovery of the usual activities or work, and radiological assessment based on plain radiograph x-rays, CT scan if needed to assess union. Radiological union is considered based on the presence of bridging callus (3/4 of cortices) in both anteroposterior and lateral views.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sex: both sexes.
  • Age: Above 18 years old.
  • Lesion: Tibial or femoral bone non-union.

排除标准

  • Skeletal immaturity.
  • Any immunosuppressive drug therapy.
  • Autoimmune disease.
  • Neoplasia.

结局指标

主要结局

Radiological Fracture Union

时间窗: According to each group ranging from 5 months in group 1, 7 in group 2 and up to 12 months in group 3

Radiological fracture union is considered based on the presence of bridging callus (3/4 of cortices) in both anteroposterior and lateral views in x rays.

Clinical Fracture Union

时间窗: According to each group ranging from 4 months in group 1, 6 in group 2 and up to 11 months in group 3.

Clinical fracture union assessment is based on presence or absence of pain at the fracture site.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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