- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05332938
Impact of Acetabular Fractures on Sports Performance (Fracture&Sport)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Prevalence of patients returning to sports after surgery at 2 years
Time Frame: Year 2
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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.
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Year 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Complication rate
Time Frame: Year 2
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This outcome corresponds to the number of patients with postoperative complications (infection, hematoma, anemia requiring transfusion).
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Year 2
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Quality of sports recovery at 2 years
Time Frame: Year 2
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This outcome corresponds to the time to resume performance.
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Year 2
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillaume RIOUALLON, MD, Fondation Hôpital Saint-Joseph
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fracture&Sport
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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