NCT05332938

Brief Summary

Acetabular fractures are complex, relatively rare lesions that are difficult to manage. Given the surgical challenge they represent, they are often managed by expert centers. The overall incidence of these fractures is around 3 fractures/100,000 persons/year. It is now well established that the quality of the reduction obtained is an important predictive factor of the postoperative outcome in patients with displaced acetabular fractures. Obtaining an anatomical reduction, at least satisfactory, is not always easy, even in trained teams. Indeed, it can be difficult because of the structural environment. This is due to the proximity of the acetabulum to the vasculo-nervous elements, but also to the complexity of the fracture itself. The contribution of new technologies appear to be important tools to achieve this objective. Indeed, investigators have demonstrated that the use of the O-ARM imaging system (Medtronic®, Sofamor, Memphis, TN) allowed the improvement of their results. Although they occur more frequently in the elderly population, the average incidence is maintained in the 20-59 age group. In these young populations, the fracture occurs most frequently as a result of a high-energy mechanism (road accident, more exceptionally, during a sporting activity). These patients, in the prime of their lives, are often athletic. The desire to resume sports after surgery is a powerful motivating factor for these patients. Often, it is the primary measure of surgical success from the athlete's perspective. In a previous work, Giannoudis et al. reported a 42% rate of return to activity at the previous level. The quality of the surgery is associated with the possibility of resuming sports activity after the procedure. Thus, the objective of this work is to determine the results of acetabular surgery in a population of previously athletic patients, in particular the return to athletic performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
283

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

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

April 1, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

April 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

April 1, 2022

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of patients returning to sports after surgery at 2 years

    This outcome corresponds to the number of patients who have returned to sport at the same level, performing at or above their pre-injury level, without time limitation.

    Year 2

Secondary Outcomes (2)

  • Complication rate

    Year 2

  • Quality of sports recovery at 2 years

    Year 2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18 to 45 years at the time of surgery at Saint Joseph Hospital, victims of an isolated acetabulum fracture, having received intraoperative management with O-ARM, with at least 2 years of follow-up

You may qualify if:

  • Patients aged 18 to 45 years at the time of surgery at Saint Joseph Hospital
  • Patients with an isolated acetabulum fracture
  • Patients with intraoperative management with O-Arm
  • Patients with at least 2 years of follow-up
  • French-speaking patients

You may not qualify if:

  • Presence of pre- or post-operative neurological lesions
  • Presence of associated fractures
  • ASA (American Society of Anesthesiologists) score ≥ 3
  • Absence of pre- and postoperative CT scans available on PACS
  • Patients under guardianship or curatorship
  • Patients deprived of liberty
  • Patients under court protection
  • Patients objecting to participation in the study
  • Low preoperative physical activity (= UCLA Activity Score ≤ 5)
  • Unsatisfactory criteria for surgical reduction on CT scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (7)

  • Lundin N, Huttunen TT, Berg HE, Marcano A, Fellander-Tsai L, Enocson A. Increasing incidence of pelvic and acetabular fractures. A nationwide study of 87,308 fractures over a 16-year period in Sweden. Injury. 2021 Jun;52(6):1410-1417. doi: 10.1016/j.injury.2021.03.013. Epub 2021 Mar 14.

    PMID: 33771345BACKGROUND
  • Tannast M, Najibi S, Matta JM. Two to twenty-year survivorship of the hip in 810 patients with operatively treated acetabular fractures. J Bone Joint Surg Am. 2012 Sep 5;94(17):1559-67. doi: 10.2106/JBJS.K.00444.

    PMID: 22992846BACKGROUND
  • Giannoudis PV, Grotz MR, Papakostidis C, Dinopoulos H. Operative treatment of displaced fractures of the acetabulum. A meta-analysis. J Bone Joint Surg Br. 2005 Jan;87(1):2-9.

    PMID: 15686228BACKGROUND
  • Ziran N, Soles GLS, Matta JM. Outcomes after surgical treatment of acetabular fractures: a review. Patient Saf Surg. 2019 Mar 16;13:16. doi: 10.1186/s13037-019-0196-2. eCollection 2019.

    PMID: 30923570BACKGROUND
  • Rizkallah M, Sebaaly A, Melhem E, Moreau PE, Upex P, Jouffroy P, Riouallon G. Clinical impact of intraoperative cone beam tomography and navigation for displaced acetabular fractures: a comparative study at medium-term follow-up. Int Orthop. 2021 Jul;45(7):1837-1844. doi: 10.1007/s00264-021-05076-4. Epub 2021 May 22.

    PMID: 34021374BACKGROUND
  • Melhem E, Riouallon G, Habboubi K, Gabbas M, Jouffroy P. Epidemiology of pelvic and acetabular fractures in France. Orthop Traumatol Surg Res. 2020 Sep;106(5):831-839. doi: 10.1016/j.otsr.2019.11.019. Epub 2020 Feb 1.

    PMID: 32019733BACKGROUND
  • Doege J, Ayres JM, Mackay MJ, Tarakemeh A, Brown SM, Vopat BG, Mulcahey MK. Defining Return to Sport: A Systematic Review. Orthop J Sports Med. 2021 Jul 26;9(7):23259671211009589. doi: 10.1177/23259671211009589. eCollection 2021 Jul.

    PMID: 34377709BACKGROUND

Related Links

Study Officials

  • Guillaume RIOUALLON, 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

April 1, 2022

First Posted

April 18, 2022

Study Start

April 10, 2022

Primary Completion

May 10, 2022

Study Completion

September 11, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations