MANAGEMENT OF THORACOLUMBAR FRACTURES AS PERTLICS GUIDELINES –AND MINI OPEN THORACOTOMY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1)Restoration of saggital and coronal balance by digital X ray
研究概览
简要总结
In this prospective study, 40 consecutive patients with single level traumatic fracture of T11, T 12, LV1. Age (20-80 years), Sex (Males and Females) willbe studied. CLASSIFICATION As per TLICSSCALE into CONSERVATIVE (TLICS score ≤ 3), OBSERVANT ( TLICS SCORE =4) who will be operated on deterioration, OPERATIVE--- (TLICS SCORE >4). Conservative group willbe managed with 4 weeks strict bed rest. Partial mobilisation with Taylor’sbrace 8 wks. Guarded mobility without Taylor’s brace. Imaging for parameters ofinstability at 3 and 6 months then yearly. The patients who fall in surgicalgroup will undergo mini open-thoracotomy, corpectomy with end plated expandabletitanium cage and screw rod constructfixation. Postoperatively all the patients will be mobilised on the same postop evening. Bedside portable x ray will be done on post op evening. Digitalx-ray, Bed side PFT will be done on 3rdday. Diaphragmatic movement by USG will be assessed on 7th day. VAS score will be recordedfrom post operative evening to 10 days. Mechanical spirometer and fluoroscopic diaphragmatic movement will be done on 12th day. CT/MRI will be done on 14thday. Post operatively these patients will be examined forrestoration of saggital and coronal balance, kyphotic correction,neurological deterioration, pulmonary function tests and restoration ofdiaphragamatic movements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Single level Traumatic fractures(T11, T12 & L1).
- •Thoraco lumbar fractures who were treated elsewhere without proper workup upto 3 months.
- •Patients who were unwilling initially for surgery who later developed instability up to one year.
排除标准
- •Pathological fractures.
- •Concomitant fractures in the vertebral column.
- •Long standing fractures with pseudoarthrosis.
- •Disabling co morbidities like lung pathology which would interfere with post op assessment of pulmonary function.
结局指标
主要结局
1)Restoration of saggital and coronal balance by digital X ray
时间窗: upto 5 years
2)Kyphotic correction, neurological deterioration by CT and MRI
时间窗: upto 5 years
on 12th post operative day, after 3 months, after 6 months and yearly thereafter upto 5 years.
时间窗: upto 5 years
Post operatively these patients will be examined for
时间窗: upto 5 years
4)Restoration of diaphragmatic movements by Fluroscopy and USG
时间窗: upto 5 years
3)Pulmonary function tests by mechanical spirometry
时间窗: upto 5 years
次要结局
- Restoration of saggital and coronal balance(5 years)