NL-OMON48485招募中不适用
K-wire fixation with direct moBilization versus Open Reposition anD intErnal fixation with direct mobilizAtion in Unstable proXimal phalangeal shaft fractures. - BORDEAUX-study
Maasziekenhuis0 个研究点目标入组 106 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •a. Population (base)
- •- All adult patients with unstable shaft fractures and fractures with a
- •symptomatic rotational or angular deformity of the proximal phalanx requiring
- •operative treatment.
- •b. Inclusion criteria
- •- Patients >=18 years
- •- Single proximal phalangeal shaft fracture
- •- Unstable proximal phalangeal shaft (extra-articular) fracture requiring
- •operative treatment. Unstable is defined as:
- •o transverse of oblique fractures with rotational disorders
- •o scissoring fingers in flexion
- •o dislocation or re-dislocation (after closed reduction) in a cast:
- •* >2mm shortening
- •* >2mm translocation
- •* >25 degrees angulation
- •- All comminuted proximal phalangeal fractures
- •- All proximal phalangeal fractures (regardless exact dislocation measures)
- •resulting in swan neck-deformity, pseudo claw hand, shortening with extension
- •- Proximal phalangeal fractures with acceptable reduction at the ED,
- •re-dislocated within 1 week after the ED (evaluated by radiograph at the
- •out-patient clinic)
排除标准
- •c. Exclusion criteria
- •- - Stable proximal phalangeal shaft (extra-articular) fracture requiring
- •conservative treatment. Stable is defined as:
- •o transverse of oblique fractures without rotational disorders
- •o no scissoring fingers in flexion
- •o no dislocation or re-dislocation (after closed reduction) in a cast:
- •* <2mm shortening,
- •* <2mm translocation
- •* <25 degrees angulation
- •- Proximal phalangeal fractures with acceptable reduction at the ED (evaluated
- •with a radiograph at the ED) without re-dislocation within 1 week (evaluated by
- •a radiograph within 1 week at the out-patient clinic) requiring conservative
- •- Proximal phalangeal shaft fracture of the thumb.
- •- Open fractures
- •- Multiple proximal phalangeal fractures
- •- Patients with impaired hand function prior to injury due to
- •arthrosis/neurological disorders of the upper limb
- •- Multiple trauma patients (Injury Severity Score (ISS) >=16)
- •- Other injuries in the ipsilateral extremity
- •- Insufficient comprehension of the Dutch language to understand a
- •rehabilitation program and other treatment information as judged by the
- •attending physician
- •- Patient suffering from disorders of bone metabolism other than osteoporosis
- •(i.e. Paget*s disease, renal osteodystrophy, osteomalacia)
- •- Patients suffering from connective tissue disease or (joint)
- •hyper-flexibility disorders such as Marfan*s, Ehler Danlos or other related
研究者
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