Evaluation of the Management of Bone Loss in Orthopaedic Surgery Using the Masquelet Technique or Transport Nails
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Rate of radiological consolidation
研究概览
简要总结
This is a single-center prospective observational study comparing two techniques for reconstructing bone loss in the lower limbs. The aim of the study was to compare the results of reconstructions using the Masquelet technique with reconstructions using electromagnetic transport nails. The primary endpoint was time to bone healing. This study is the first prospective descriptive study of electromagnetic transport nails.
详细描述
Segmental bone defects pose a major challenge in orthopaedics due to various causes like trauma, oncology resections, or chronic osteomyelitis. Reconstruction techniques are complex, with Masquelet's method being the most widely used in France, despite mixed outcomes and complications. A novel electromagnetic bone transport technique via intramedullary nailing has emerged as a promising alternative. The primary goal of the study is to compare consolidation times between these two approaches for metaphyseal-diaphyseal bone loss in the lower limbs. Secondary objectives include assessing patient demographics, functional outcomes, quality of life, hospital stays, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Patient ≥ 18 years
- •Minor patient, able to consent to data collection, with the consent of the owner(s)
- •Patient consulting for a medical reason involving a loss of bone substance in the lower limb in an investigating centre linked to one of these aetiologies for which a reconstruction procedure using a transport nail or Masquelet technique is envisaged:
- •Tumour pathologies requiring
- •Septic or aseptic pseudarthrosis
- •Traumatic pathology
- •Infectious pathologies
排除标准
- •Patients under guardianship or curatorship,
- •Individuals deprived of their liberty by judicial or administrative decision,
- •Individuals receiving involuntary psychiatric care requiring the consent of their legal representative,
- •Individuals unable to express their consent,
- •Individuals under legal protection,
- •Patients with an indication for bone reconstruction using a technique other than the Masquelet technique and nail transport,
- •Patients not covered by a social security scheme,
- •Patients ineligible for bone reconstruction due to their comorbidities
研究组 & 干预措施
Transport nail
Patient consulting for a medical reason involving a loss of bone substance in the lower limb in an investigating centre linked to one of these aetiologies for which a reconstruction procedure using a transport nail is envisaged
干预措施: Data collection and self-administered questionnaire. (Other)
Masquelet's method
Patient consulting for a medical reason involving a loss of bone substance in the lower limb in an investigating centre linked to one of these aetiologies for which a reconstruction procedure using a Masquelet technic is envisaged
干预措施: Data collection and self-administered questionnaire. (Other)
结局指标
主要结局
Rate of radiological consolidation
时间窗: From enrollment to 36 months after
Radiological consolidation is defined by an anteroposterior and lateral radiograph showing at least three out of four cortical plates consolidated. This assessment is performed during follow-up by the physician treating the patient and will be confirmed by an evaluation committee at a later stage.
次要结局
- Functional outcomes : score MSTS(Baseline, 12 months, 24 months and 36 months)
- Time to full weight-bearing(Baseline, 3 months, 6 months, 12 months, 24 months and 36 months)
- . Functional outcomes : score LEFS(Baseline, 12 months, 24 months and 36 months)
- Functional outcomes : paley Marr score.(Baseline, 12 months, 24 months and 36 months)
- Quality of life(Baseline, 12 months, 24 months and 36 months)
- Adverse events and complications(3 months, 6 months, 12 months, 24 months and 36 months)
- Bone consolidation rate(From enrollment to 36 months after)