Fracture&Sport: Impact of Acetabular Fractures on Sports Performance

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05332938
Collaborator
(none)
283
1
32.7
8.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    283 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Impact of Acetabular Fractures on Sports Performance
    Actual Study Start Date :
    Apr 10, 2022
    Actual Primary Completion Date :
    May 10, 2022
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of patients returning to sports after surgery at 2 years [Year 2]

      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.

    Secondary Outcome Measures

    1. Complication rate [Year 2]

      This outcome corresponds to the number of patients with postoperative complications (infection, hematoma, anemia requiring transfusion).

    2. Quality of sports recovery at 2 years [Year 2]

      This outcome corresponds to the time to resume performance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: Guillaume RIOUALLON, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT05332938
    Other Study ID Numbers:
    • Fracture&Sport
    First Posted:
    Apr 18, 2022
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022