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

Pertrochanteric Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02868125
• Other study ID #: 0172
• Status: Active, not recruiting
• Phase: N/A
• First received: August 10, 2016
• Last updated: August 13, 2016
• Start date: May 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2016
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pertrochanteric femur fracture, classified as AO-31-A

• Go through a closed reduction and internal fixation operation at the investigator's institution

Exclusion Criteria:

• patients that due to clinical findings or other necessities go through specific followup radiography imaging protocols

• Fluoroscopy imaging studies were not saved

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pertrochanteric Fracture

Intervention

Radiation:
• X ray radiography
All studied patients will undergo an x-ray radiography of the operated hip. This protocol is a part of the investigators' common practice policy regardless of the study.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Tufescu T. Working toward reducing postoperative fracture radiographs: a survey of Canadian surgeons. Can J Surg. 2016 Feb;59(1):26-8. — View Citation

van Embden D, Stollenwerck GA, Koster LA, Kaptein BL, Nelissen RG, Schipper IB. The stability of fixation of proximal femoral fractures: a radiostereometric analysis. Bone Joint J. 2015 Mar;97-B(3):391-7. doi: 10.1302/0301-620X.97B3.35077. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weight bearing instructions on follow up x ray imaging	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.	OIne week	No
Secondary	Changes in neck shaft angle between intra-operative fluoroscopy and follow-up x ray imaging studies	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.	one week	No
Secondary	The need for reoperation	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.	One week	No
Secondary	Changes in neck length between intra-operative fluoroscopy and follow-up x ray imaging studies	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.	One week	No
Secondary	Changes in tip-apex distance between intra-operative fluoroscopy and follow-up x ray imaging studies	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.	One week	No