Overview

This trial is active, not recruiting.

Condition pertrochanteric fracture
Treatment x ray radiography
Sponsor Meir Medical Center
Start date May 2016
End date May 2017
Trial size 300 participants
Trial identifier NCT02868125, 0172

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Changes in weight bearing instructions on follow up x ray imaging
time frame: OIne week

Secondary Outcomes

Measure
Changes in neck shaft angle between intra-operative fluoroscopy and follow-up x ray imaging studies
time frame: one week
The need for reoperation
time frame: One week
Changes in neck length between intra-operative fluoroscopy and follow-up x ray imaging studies
time frame: One week
Changes in tip-apex distance between intra-operative fluoroscopy and follow-up x ray imaging studies
time frame: One week

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Radiography Protocol in the Acute Phase After Proximal Femur Internal Fixation- Self Assessment and Recommendations
Principal investigator David Segal, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Meir Medical Center.