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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient, male or female, aged ≥ 18 years

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anatomical reconstruction

    Procedure/Surgery

    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

  • Broström anatomical repair

    Procedure/Surgery

    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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Broström's anatomical repair groupActive comparator 1 intervention
Group B: Anatomical reconstruction groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sporting activity

Patients' 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.

Time frame
Year 5

Secondary outcomes

Other outcomes

Sponsors and contacts

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