Vascular surgery department, Ambroise Paré Hospital, APHP
Boulogne-Billancourt, Hauts-de-Seine, 92100, France
NCT Number: NCT07147556
Functional popliteal artery entrapment syndrome (FPAES) is a rare and under-diagnosed clinical entity characterized by dynamic compression of the popliteal artery during exercise in the absence of a visible anatomic abnormality at rest. It preferentially affects young, otherwise healthy athletes (3,4). Although surgical release is the reference treatment, the literature relies mainly on small case series, surgical management is poorly standardized, and data on early post-operative morbidity (complications, re-hospitalization) are often lacking. This prospective, single-center, non-interventional study aims to describe the safety of the surgical management of FPAES as performed in routine care in the vascular surgery department of Ambroise Paré Hospital (AP-HP), a national reference center for this condition. The primary endpoint is the rate of re-hospitalization within 30 days of surgery. Secondary objectives address risk factors for re-hospitalization, minor adverse events, and the clinical and functional outcome of patients, including return to sport, assessed using the Lower Extremity Functional Scale (LEFS).
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Boulogne-Billancourt, Hauts-de-Seine, 92100, France
This is a prospective, single-center, non-interventional study conducted in the vascular surgery department of Ambroise Paré Hospital (AP-HP). Adult patients undergoing surgical management for FPAES are enrolled prospectively over a 24-month inclusion period (target: 138 patients) and followed for 36 months. Eligible patients are identified at the pre-operative consultation. Demographic, surgical, and clinical data are collected from the medical record at follow-up visits (M1, M3, M6, M12, M24, M36). The primary outcome is the rate of re-hospitalization within 30 days of surgery; post-operative adverse events (hematoma, surgical-site infection, deep vein thrombosis, and re-hospitalization) are recorded through day 30. Patient-reported lower-extremity function is assessed with the Lower Extremity Functional Scale (LEFS; validated French version), self-completed on paper the day before surgery and again at 6 months. Statistical analyses will be performed in R: the 30-day re-hospitalization proportion will be estimated with its 95% confidence interval (Wilson method), risk factors will be examined by univariate then multivariate logistic regression, and the change in LEFS impairment categories between baseline and 6 months will be compared using a test for paired data.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at 30 days
The primary endpoint is the proportion of patients re-hospitalized for any cause within the 30 days following the surgical procedure.
Time frame: at 30 days
Time frame: at baseline and 6 months
Use scale (LEFS; validated French version)
Time frame: at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36
Clinical evolution and improvement during follow-up
Time frame: at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36
Return to sporting activity during follow-up
Contact information is provided by the study sponsor or research team.
Mohammad Zagzoog, MD
CONTACT
Raphaël COSCAS, MD, PhD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: SAPP-F
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