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

NCT02868125 | Unknown

• 1 other identifier: 0172
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pertrochanteric Fracture

Keywords

pertrochanteric; radiography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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 neck length between intra-operative fluoroscopy and follow-up x ray imaging studies

  One week

• Changes in tip-apex distance between intra-operative fluoroscopy and follow-up x ray imaging studies

  One week

Interventions

X ray radiography RADIATION

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 4423505, Israel

Location

Related Publications (3)

• 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.

  PMID: 26812405 BACKGROUND

• 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.

  PMID: 25737524 BACKGROUND

• 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.

  PMID: 30064462 DERIVED

MeSH Terms

Interventions

Portable X-Ray

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• David Segal, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. David Segal

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 16, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)