Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation

NCT07886463 | Recruiting

• 2 other identifiers: 2026-52-SBM2026-A01650-51
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic lateral ankle instability is a common condition in athletic populations and may lead to persistent biomechanical alterations despite appropriate management. This condition typically develops following one or more ankle sprains and is characterized by a sensation of instability, episodes of the ankle giving way, pain, or discomfort during physical or sporting activities. When conventional treatments such as rehabilitation, physiotherapy, and activity modification do not provide sufficient improvement, surgical ligament repair may be recommended. Although this surgery generally restores ankle stability, there is currently limited evidence regarding how lower-limb function evolves following the procedure. In particular, there is no established objective reference measure to assess functional recovery and support healthcare professionals in making decisions regarding rehabilitation or return to sport. The prospective interventional comparative analysis proposed in this study aims to evaluate surgery-induced changes in ankle and lower-limb movement and function that can be objectively quantified through biomechanical motion analysis.

Conditions

Chronic Lateral Ankle Instability

Keywords

Arthroscopic ligament repair; Biomechanics; Kinematics; Movement analysis

Outcome Measures

Primary Outcomes (1)

• Change in biomechanical parameters derived from three-dimensional motion analysis

  Change in Kinematic parameters derived from three-dimensional motion analysis between the preoperative assessment (T0), the 3-month postoperative assessment (T1), and the 6-month postoperative assessment (T2). Kinematic variables include ankle, knee, hip, trunk, and pelvic joint angles (°). Data will be collected using a 12-camera Qualisys MIQUS M3 optoelectronic motion capture system (Qualisys AB, Gothenburg, Sweden).

  From enrollement to 6 months after surgery

Secondary Outcomes (9)

• Changes in Kinetic Moments Measurements

  From enrollement to 6 months after surgery

• Changes in Spatiotemporal Parameters

  From enrollement to 6 months after surgery

• Limb Symmetry Index (LSI) for selected biomechanical parameters

  From enrollement to 6 months after surgery

• Change in Limb Symmetry Index over time

  From inclusion to 6 months post-surgery

• Countermovement Jump (CMJ) Height

  From Inclusion to 6 months post-surgery

Study Arms (1)

Motion analysis participants

EXPERIMENTAL

Participants with chronic lateral ankle instability who regularly engage in physical activity and/or sports and are scheduled to undergo lateral ankle ligament repair. Biomechanical motion analysis will be performed preoperatively and at 3 and 6 months postoperatively.

Other: Biomechanical motion analysis

Interventions

Biomechanical motion analysis OTHER

The studied parameters will be categorized as follows: Kinematics * Ankle dorsiflexion/plantarflexion, inversion/eversion, and foot internal/external rotation angles * Knee flexion and valgus/varus angles * Hip flexion, adduction/abduction, and internal/external rotation angles * Trunk flexion/extension * Pelvic frontal plane tilt Kinetics and Inverse Dynamics * Ankle, knee, and hip extensor joint moments * Knee adduction moment * Positive and negative joint power at the knee and ankle * Vertical ground reaction force (vGRF) * Anterior-posterior braking and propulsion forces Spatiotemporal Parameters * Ground contact time * Stance and flight phase durations * Jump height (countermovement jump \[CMJ\] and drop jump) The three-dimensional biomechanical analysis will be performed using a 12-camera Qualisys MIQUS M3 motion capture system synchronized with two floor-embedded AMTI force platforms to quantify lower-limb kinematics, kinetics, and spatiotemporal parameters

Also known as: three-dimensional biomedical motion analysis, Functional biomechanical analysis

Motion analysis participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Standard indications for lateral ankle ligament repair surgery for chronic lateral ankle instability refractory to conservative treatment.
• Participation in physical activity and/or sports at least once weekly before the onset of symptoms leading to the surgical indication.

You may not qualify if:

• Concomitant surgical procedures likely to alter postoperative recovery.
• History of major lower-limb fractures.
• Associated injuries involving the lower limbs or lumbar spine.
• Any other surgery performed within 6 months prior to the index procedure.

Sponsors & Collaborators

• Clinique du Sport, Bordeaux Mérignac: lead

Study Sites (1)

Clinique du Sport

Mérignac, 33700, France

RECRUITING

Study Officials

• Guillaume Cordier, MD

  Clinique du sport

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Mandon, PhD

CONTACT

+33 6 78 27 76 72; DRC@vivalto-sante.com

Emma Escoffier, Master

CONTACT

+ 33 6 88 92 33 17; eescoffier@vivalto-santé.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 21, 2026
• Study Start: October 20, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)