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Not yet recruiting NCT07147556

Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Short- and Mid-Term Results

Observational Popliteal Artery Entrapment Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Popliteal Artery Entrapment Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Rate of re-hospitalization within 30 days after surgery [Time frame: at 30 days]
Secondary outcome measures (4)
  • Demographic data, surgery-related data, and associated medical and surgical history associated with re-hospitalization within 30 days post-surgery. [Time frame: at 30 days]
  • Change in patient-reported lower-extremity function and impairment category, assessed with the Lower Extremity Functional Scale [Time frame: at baseline and 6 months]
  • Clinical evolution [Time frame: at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36]
  • Return to sporting activities [Time frame: at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Vascular surgery department, Ambroise Paré Hospital, APHP — Boulogne-Billancourt

Publications

  • Singh N. Functional popliteal entrapment: A diagnostic and treatment conundrum. J Vasc Surg. 2019 Nov;70(5):1563. doi: 10.1016/j.jvs.2019.02.019. No abstract available. PMID 31653376
  • Hislop M, Kennedy D, Cramp B, Dhupelia S. Functional Popliteal Artery Entrapment Syndrome: Poorly Understood and Frequently Missed? A Review of Clinical Features, Appropriate Investigations, and Treatment Options. J Sports Med (Hindawi Publ Corp). 2014;2014:105953. doi: 10.1155/2014/105953. Epub 2014 Sep 7. PMID 26464888
  • Rignault DP, Pailler JL, Lunel F. The "functional" popliteal entrapment syndrome. Int Angiol. 1985 Jul-Sep;4(3):341-3. PMID 3831156
  • Turnipseed WD. Functional popliteal artery entrapment syndrome: A poorly understood and often missed diagnosis that is frequently mistreated. J Vasc Surg. 2009 May;49(5):1189-95. doi: 10.1016/j.jvs.2008.12.005. PMID 19394547
  • Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83. PMID 10201543

Identifiers

NCT: NCT07147556 · APHP251098 · 2026-A00402-49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗