跳至主要内容
临床试验/CTRI/2024/08/072665
CTRI/2024/08/072665尚未招募不适用

Interlocking Nailing in Shaft of Humerus with Three Stitch Technique

Dr Sachin kale1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
To evaluate the efficacy of three stitch technique as a surgical modality in treatment of fracture of shaft of humerus

研究概览

简要总结

Humeral shaft fractures may be defined as the disruption of the bony cortex along the diaphyseal aspect of the humerus. Fractures of the shaft of the humerus account for 1% to 3% of all fractures and approximately 20% of all fractures involving the bone. There is a bimodal distribution of injury which peaks in the third and seventh decades, with high energy mechanisms for younger populations and low energy mechanisms for the elderly

elderly.

Treatment of these fractures involve both non-surgical and surgical management. N surgical interventions utilised includes shoulder spicas, abduction splints, Velpeau bandages, and Thomas arm splints. Surgical fixation by means of open reduction and internal fixation (ORIF), intramedullary nailing (IM nail) and minimally invasive plate osteosynthesis(MIPO) helps achieve fracture healing and early mobilisation of adjacent joints. Hence, the use of surgical techniques in the fixation of diaphyseal humeral fractures has increased in the last few years.

In open reduction and internal fixation (ORIF), fracture can be visualised using different approaches and a plate with screws is used.

Advantages include direct visualisation of the fracture site and a high probability of anatomic reduction, with absolute stability and direct bone healing. Disadvantages include extensive dissection, iatrogenic injuries, infection, and the possibility of further operation.

Plate osteosynthesis provides rigid fixation and a good functional recovery. However, it requires a wide surgical exposure increasing chances of intra-op complications and more time when compared with intramedullary fixation.

Intramedullary nailing (IM nail) for diaphyseal humeral fractures gained popularity due to the minimal dissection needed and the preservation of the fracture haematoma, utilising relative stability and indirect healing. The disadvantages of IM nails are a higher rate of shoulder pain and re-operation, as well as an increased risk of rotational malignment. Intramedullary nail act as load sharing and stress shielding devices. The most commonly used are the ante grade and retrograde humerus nailing.

However, there have been associated concerns like shoulder impairment due to rotator cuff violation, cartilage damage, proximal nail migration or adhesive capsulitis with the use of ante grade intramedullary nail. Also, the distal locking involves insertion of the antero-posterior screw at the transition zone of the lower third humerus which is difficult and carries a risk of neurovascular injury. Latero-medial locking, on the other hand, can cause injury to the radial or lateral cutaneous nerve.

Retrograde nailing was introduced in order to elude these aforementioned complications and technical difficulties. However, apart from being technically demanding procedure, this technique has pitfalls like posterior cortex comminution due to high nail resistance (due to the triangular geometry of distal the humerus providing less space for the nail insertion) and stiffness of the elbow joint due to the violation of triceps muscle.

So taking into consideration the benefits and disadvantages of various surgical techniques, we have come up with the three stitch technique for ante grade humerus nailing. The goal is to avoid all surgical difficulties and complications encountered during the use of traditional method of antegrade humerus nailing.

研究设计

研究类型
Observational

入排标准

年龄范围
25.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients giving consent to be part of this study.
  • Patients with history of trauma causing fracture of diaphyseal numeral shaft.
  • Patient showing X ray changes of fracture of diaphyseal humerus shaft.
  • Patient willing and motivated for surgery.

排除标准

  • Skeletally immature patients Pathological fractures Associated radial nerve palsy Clinically detectable focus of active infection Not willing for surgery.

结局指标

主要结局

To evaluate the efficacy of three stitch technique as a surgical modality in treatment of fracture of shaft of humerus

时间窗: 12 weeks post operative period

次要结局

  • To study short term & long term functional outcome after use of interlocking nail for diaphyseal fracture of humerus using three stitch technique(2 , 4 weeks , 3 months 6 months, 1 year post operative period)

研究者

发起方
Dr Sachin kale
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shashwat Anand

Dy Patil hospital and school of medicine

研究点 (1)

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