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Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability

Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06945198
Acronym
ANKLE STAB
Enrollment
200
Registered
2025-04-25
Start date
2026-04-29
Completion date
2031-06-30
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Instability

Brief summary

The goal of this clinical trial is to compare at 5 years the sporting activity of patients whose ankle had been treated by reconstruction or repair following chronic lateral instability. The main question it aims to answer is: What is the long-term sporting activity status of patients whose ankle had been treated by reconstruction or repair following chronic lateral instability ? Participants will visit the clinic once every year during 5 years for clinical checkup.

Interventions

PROCEDUREAnatomical reconstruction

Anatomical ligamentoplasty or anatomical reconstruction is performed under arthroscopy. The principle of this method, which lasts around 40 minutes under spinal anaesthetic or general anaesthetic, is to reconstruct the LTFA and sometimes also the LCF, if it has been damaged, using a fragment of the tendon gracilis, located in the thigh, removed through an incision under the knee

PROCEDUREBroström anatomical repair

Broström's anatomical repair is performed under arthroscopy. The principle of this method is to tighten and reattach the LTFA using very small anchors, when it is detached from the fibula but not too retracted and still of good quality. If necessary, this may also be accompanied by ligament reinforcement ('gould'), using a fragment of a fibrous structure in the ankle, the extensor retinaculum

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient, male or female, aged ≥ 18 years * Patient with chronic ankle instability defined by: * A history of trauma including a severe ankle sprain. * Clinical symptoms persisting for at least 3 months at the time of inclusion: pain, swelling, sensation of 'giving way', sensation of instability, recurrent sprains; Clinical tests (drawer test, varus provocation test) confirming grade III laxity; Imaging results (MRI) confirming clinically suspected ligament damage. * Patient affiliated to or benefiting from a social security scheme * French-speaking patient who has signed an informed consent form

Exclusion criteria

* Patient with deltoid ligament injury, severe fracture or open trauma * Patient with insufficient ligament remnant and/or in too poor a condition to allow Broström-type repair. * Patient with a symptomatic osteochondral lesion * Patient with ankle hyperlaxity (Beighton score \> 3) * Patient with early ankle arthropathy (Takakura arthritis classification ≥ stage 3) * Patient with neuromuscular disorders, systemic inflammatory disorders or tumours. * Patient requiring surgery on both ankles * Patients with a bony deformity of the ankle or foot on the affected side; * Patients with professional athlete status * Patient already included in another study * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Design outcomes

Primary

MeasureTime frameDescription
Sporting activityYear 5Patients' sporting activity will be assessed using the "Sport" subscale of the Quick FAAM (Foot and Ankle Ability Measure) questionnaire. Minimum value is 0 and maximum value is 32. 32 means a better outcome.

Countries

France

Contacts

CONTACTRonny LOPES, MD
docteurronnylopes@gmail.com+33 6 03 70 60 87

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026