NCT04626388

Brief Summary

Acetal fractures are joint fractures that occur in the hip. These fractures affect the functional prognosis of the hip in the short, medium and long term. In the acetabulum fractures operated on, there is a radiological score in the literature allowing the prognosis to be predicted depending on the quality of the postoperative reduction. This score is based on the quality of postoperative reduction assessed on pelvic radios. In addition, the thresholds for poor / good results were determined empirically.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

December 9, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2023

Completed
Last Updated

September 13, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

November 10, 2020

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total hip replacement

    This ouctome corresponds to the total hip prosthesis.

    Year 2

Secondary Outcomes (2)

  • Post-operative complications

    Year 2

  • Delay of total hip replacement

    Year 2

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients were operated on for an acetabulum fracture within the Paris Saint Joseph Hospital Group, between January 2004 and December 2014, with a minimum post-operative follow-up of 2 years.

You may qualify if:

  • Patient whose age is ≥ 18 years
  • Patient operated on for an acetabular fracture at the GHPSJ between January 2004 and December 2014
  • Patient with a minimum postoperative follow-up of 2 years
  • French-speaking patient

You may not qualify if:

  • Patient treated conservatively.
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under legal protection
  • Patient objecting to the use of his medical data as part of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (5)

  • Matta JM, Mehne DK, Roffi R. Fractures of the acetabulum. Early results of a prospective study. Clin Orthop Relat Res. 1986 Apr;(205):241-50.

  • Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.

  • Verbeek DO, van der List JP, Villa JC, Wellman DS, Helfet DL. Postoperative CT Is Superior for Acetabular Fracture Reduction Assessment and Reliably Predicts Hip Survivorship. J Bone Joint Surg Am. 2017 Oct 18;99(20):1745-1752. doi: 10.2106/JBJS.16.01446.

  • Jouffroy P, Sebaaly A, Aubert T, Riouallon G. Improved acetabular fracture diagnosis after training in a CT-based method. Orthop Traumatol Surg Res. 2017 May;103(3):325-329. doi: 10.1016/j.otsr.2016.10.020. Epub 2016 Dec 23.

  • Verbeek DO, van der List JP, Moloney GB, Wellman DS, Helfet DL. Assessing Postoperative Reduction After Acetabular Fracture Surgery: A Standardized Digital Computed Tomography-Based Method. J Orthop Trauma. 2018 Jul;32(7):e284-e288. doi: 10.1097/BOT.0000000000001161.

Study Officials

  • Elias MELHEM, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 12, 2020

Study Start

December 9, 2020

Primary Completion

January 9, 2023

Study Completion

September 11, 2023

Last Updated

September 13, 2023

Record last verified: 2023-04

Locations