NCT04073329

Brief Summary

It is widely accepted in the literature that quality of acetabular fracture reduction is one of the most important factor for the outcome. To obtain best results, anatomical reduction has to be obtained. Intra-operative radiographic assessment depends mainly on plain x-ray. Plain x-ray alone is not enough for post-operative assessment as it depends mainly on reduction of the dome with concentricity of the hip.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
4.1 years until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

August 27, 2019

Last Update Submit

November 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ability of CT scans and plain radiographs to detect residual articular steps and gaps after healing of acetabular fractures managed by open reduction and internal fixation.

    measurement was used to grade quality of reduction according to Matta's system . In accordance with prior studies, adequate (or anatomic) reductions with 0-1 mm of displacement were compared to inadequate (imperfect or poor) reductions with \> 1 mm displacement . For the CT-based method, postoperative pre-digital (prior to 2000) and digital CT images were independently assessed in the axial, sagittal, and coronal planes, and residual gap and step displacement were measured along the articular surface at the level of the weight-bearing dome. Adequate reductions on postoperative CT were defined as \< 1 mm step and \< 5 mm gap displacement and inadequate reductions as ≥ 1 mm step and/or ≥ 5 mm gap displacement.

    1 year

Study Arms (2)

Plain x ray

measurement the accuracy of post operative reduction by Matta method

Other: post operative measure of reduction

CT

measure the accuracy of reduction by Verbeek method

Other: post operative measure of reduction

Interventions

measurement was used to grade quality of reduction according to Matta's system . In accordance with prior studies, adequate (or anatomic) reductions with 0-1 mm of displacement were compared to inadequate (imperfect or poor) reductions with \> 1 mm displacement . For the CT-based method, postoperative pre-digital (prior to 2000) and digital CT images were independently assessed in the axial, sagittal, and coronal planes, and residual gap and step displacement were measured along the articular surface at the level of the weight-bearing dome. Adequate reductions on postoperative CT were defined as \< 1 mm step and \< 5 mm gap displacement and inadequate reductions as ≥ 1 mm step and/or ≥ 5 mm gap displacement.

CTPlain x ray

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients included in our study will have postoperative plain X-rays and comparing it to CT scan to assess their quality of reduction and other criteria mentioned in the literature. 10 observers with different years of experience will assess all fractures using plain x-ray and CT.

You may qualify if:

  • Isolated displaced acetabular fractures
  • Skeletally mature patients

You may not qualify if:

  • Skeletally Immature

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Borrelli J Jr, Ricci WM, Steger-May K, Totty WG, Goldfarb C. Postoperative radiographic assessment of acetabular fractures: a comparison of plain radiographs and CT scans. J Orthop Trauma. 2005 May-Jun;19(5):299-304.

    PMID: 15891537BACKGROUND
  • Verbeek DO, van der List JP, Helfet DL. Computed tomography versus plain radiography assessment of acetabular fracture reduction is more predictive for native hip survivorship. Arch Orthop Trauma Surg. 2019 Dec;139(12):1667-1672. doi: 10.1007/s00402-019-03192-w. Epub 2019 Apr 27.

    PMID: 31030241BACKGROUND
  • Dodd A, Osterhoff G, Guy P, Lefaivre KA. Radiographic Measurement of Displacement in Acetabular Fractures: A Systematic Review of the Literature. J Orthop Trauma. 2016 Jun;30(6):285-93. doi: 10.1097/BOT.0000000000000538.

    PMID: 27206254BACKGROUND

Central Study Contacts

Mahmoud Badran, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 27, 2019

First Posted

August 29, 2019

Study Start

October 1, 2023

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

November 14, 2022

Record last verified: 2022-11