Radiography Protocol in the Acute Phase After Proximal Femur Internal Fixation- Self Assessment and Recommendations

• Conditions: Pertrochanteric Fracture

• Registration Number: NCT02868125
• Lead Sponsor: Meir Medical Center

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-08
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-13
• Last Update Submitted: 2016-08-13
• Study First Posted: 2016-08-16
• Last Update Posted: 2016-08-16
• Primary Completion: 2017-05
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Pertrochanteric femur fracture, classified as AO-31-A
• Go through a closed reduction and internal fixation operation at the investigator's institution

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Exclusion Criteria

• patients that due to clinical findings or other necessities go through specific followup radiography imaging protocols
• Fluoroscopy imaging studies were not saved

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in weight bearing instructions on follow up x ray imaging	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.

Secondary Outcome Measures

Name	Time	Method
Changes in neck shaft angle between intra-operative fluoroscopy and follow-up x ray imaging studies	one week	Neck-shaft angle is the angle between the femoral neck and femoral shaft, measured in degrees. The investigators wish to find whether there is a difference in the measurements' outcome for the same patients on intra-operative fluoroscopy and on the first post-operative followup x-ray imaging studies. The angle described will be calculated on both modalities and compared, with the outcome being the difference in degrees.
The need for reoperation	One week	During the few day following surgery a decision has to be made regarding need for re-operation. 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 decision is based on both objective features such as nec-shaft angle, tip-apex index and neck length, and on subjective features such as the patients' basic medical functional status. The investigators wish to learn whether a new data from the first follow up imaging study leads to changes in the decision for re-operation. 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 be advised differently for re-operation.
Changes in tip-apex distance between intra-operative fluoroscopy and follow-up x ray imaging studies	One week	Tip apex distance is the sum of the distances measured on both AP and axial studies between the proximal lag screw tip and the proximal femoral head border . It is measured by millimeters. The investigators wish to find whether there is a difference in the measurement outcome for the same patients on intra-operative fluoroscopy and on the first post-operative followup x-ray imaging studies. The length described will be calculated on both modalities and compared, with the outcome being the difference in millimeters.
Changes in neck length between intra-operative fluoroscopy and follow-up x ray imaging studies	One week	Neck length is the distance between the femoral neck base and the femoral head, and is measured in millimeters. The investigators wish to find whether there is a difference in the measurement outcome for the same patients on intra-operative fluoroscopy and on the first post-operative followup x-ray imaging studies. The length described will be calculated on both modalities and compared, with the outcome being the difference in millimeters.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel