Radiography Protocol in the Acute Phase After Proximal Femur Internal Fixation- Self Assessment and Recommendations
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Changes in weight bearing instructions on follow up x ray imaging
研究概览
简要总结
There is no standardized protocol regarding the post-operative radiographic follow up of patients that sustain pertrochanteric hip fractures and are treated with closed reduction and internal fixation. The policy in the investigator's institution as in other hospitals is to conduct a radiogram of the operated hip during the first days following operation after the patient bore weight on the fixated femur. The investigator's goal is to asses the added value of this policy and to offer recommendations regarding this specific followup component.
详细描述
There is no consensus regarding the proper radiographic protocol following closed reduction and internal fixation of pertrochanteric femoral fractures. Despite its' questionable necessity and significant economic burden, many medical centers practice a policy of imaging internally fixated proximal femurs after the patients bore weight on them. The investigator's goal is to assess the added value of the postoperative imaging study described.
Materials and methods
We will conduct a prospective study. All patients who will be treated with closed reduction and internal fixation of AO31A fractures will be enrolled. Two sets of imaging studies will be assessed- the intra-operative AP and axial fluoroscopy studies and the radiograms that are taken following bearing weight on the operated hip. Three decision steps will take place regarding weight bearing limitations and a necessity for re-operation- (1) Immediately after the operation; (2) A day after the operation; (3) Following weight bearing according to a new radiogram. Objective measurements will be taken for each hip on both imaging modalities- neck-shaft angle, neck length and tip-apex distance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pertrochanteric femur fracture, classified as AO-31-A
- •Go through a closed reduction and internal fixation operation at the investigator's institution
排除标准
- •patients that due to clinical findings or other necessities go through specific followup radiography imaging protocols
- •Fluoroscopy imaging studies were not saved
结局指标
主要结局
Changes in weight bearing instructions on follow up x ray imaging
时间窗: OIne week
During the few day following surgery a decision has to be made regarding weight bearing limitations on the operated hip. patients can be instructed to: (1) Full weight bearing, (2) Partial weight bearing, (3) Touch-down weight bearing, (4) Non weight bearing. This decision is primary taken according to the intra-operative fluoroscopy images, and revised a few days later after examining the first follow up x-ray imaging of the operated hip. The investigators wish to learn whether a new data from the first follow up imaging study leads to changes in weight bearing instructions. If a change was made due to new findings on follow up x-ray, then the case would be regarded as "change", while if no changes were made they would be regarded as "no change". Finally the investigators will calculate the number of patients that need to go through follow up x-ray imaging studies in order for one patient to have their weight bearing instructions changed.
次要结局
- Changes in neck shaft angle between intra-operative fluoroscopy and follow-up x ray imaging studies(one week)
- The need for reoperation(One week)
- Changes in tip-apex distance between intra-operative fluoroscopy and follow-up x ray imaging studies(One week)
- Changes in neck length between intra-operative fluoroscopy and follow-up x ray imaging studies(One week)
研究者
David segal, MD
Dr. David Segal
Meir Medical Center