Popliteal Artery Entrapment Syndrome
Conditions
Keywords
Functional popliteal artery entrapment syndrome, Surgical treatment, Systematic approach, Athlete, Decompression
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Adults aged 18 years or older. * Patients with documented functional popliteal artery entrapment syndrome (FPAES). * Patients undergoing surgical management of FPAES in the vascular surgery department of Ambroise Paré Hospital (AP-HP). * Having received the information note and not having expressed opposition to participation in the study.
Exclusion criteria
* Anatomical popliteal artery entrapment syndrome. * Patient refusal. * Inability to understand the proposed research and/or to express non-opposition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-hospitalization within 30 days after surgery | at 30 days | The primary endpoint is the proportion of patients re-hospitalized for any cause within the 30 days following the surgical procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic data, surgery-related data, and associated medical and surgical history associated with re-hospitalization within 30 days post-surgery. | at 30 days | — |
| Change in patient-reported lower-extremity function and impairment category, assessed with the Lower Extremity Functional Scale | at baseline and 6 months | Use scale (LEFS; validated French version) |
| Clinical evolution | at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36 | Clinical evolution and improvement during follow-up |
| Return to sporting activities | at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36 | Return to sporting activity during follow-up |
Countries
France
Contacts
CHU Ambroise Paré - APHP
Hôpital Marie Lannelongue, France