Clinical trial NCT02868125: Radiography Protocol in the Acute Phase After Proximal Femur Internal Fixation- Self Assessment and Recommendations
Official title: Radiography Protocol in the Acute Phase After Proximal Femur Internal Fixation- Self Assessment and Recommendations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pertrochanteric Fracture
Keywords: pertrochanteric
radiography
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of all ages who sustain a pertrochanteric femur fracture, classified as AO-31-A, and go through a closed reduction and internal fixation operation at the investigator's institution.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in weight bearing instructions on follow up x ray imaging
timeFrame: OIne week
Secondary outcomes:
measure: Changes in neck shaft angle between intra-operative fluoroscopy and follow-up x ray imaging studies
timeFrame: one week
measure: The need for reoperation
timeFrame: One week
measure: Changes in neck length between intra-operative fluoroscopy and follow-up x ray imaging studies
timeFrame: One week
measure: Changes in tip-apex distance between intra-operative fluoroscopy and follow-up x ray imaging studies
timeFrame: One week
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: David Segal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tufescu T. Working toward reducing postoperative fracture radiographs: a survey of Canadian surgeons. Can J Surg. 2016 Feb;59(1):26-8. doi: 10.1503/cjs.005715.
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.
citation: Segal D, Palmanovich E, Faour A, Marom E, Feldman V, Yaacobi E, Slevin O, Kish B, Brin YS. Routine early post-operative X-ray following internal fixation of intertrochanteric femoral fractures is unjustified: a quality improvement study. J Orthop Surg Res. 2018 Jul 31;13(1):189. doi: 10.1186/s13018-018-0896-9.