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NCT Number: NCT06720649

Benefits of Ballistic Tests After the Anterior Cruciate Ligament Surgery

During physical activities, the time available to produce a force is infinitely shorter than the time required to reach maximal muscle capacity.

Previous studies have observed that the time elapsed between ground contact and ACL rupture is on average 50-60 ms, suggesting that this is the time window available for any attempt at dynamic stabilization of the joint through muscle contraction.

Sports movements include ballistic movements, defined as very fast movements whose objective is to accelerate a moving mass as much as possible so that it reaches a high speed in a very short time. This is the case for vertical jumps, running and most movements performed in physical and sporting activities.

Thus; (1) isokinetic tests do not allow a rigorous analysis of the components related to the speed of the movement; (2) functional tests such as jumping, which only give a distance between one leg and the other, do not allow the calculation of precise and reproducible variables concerning the force and speed of the movement, in particular during the first milliseconds of the movement, and do not provide information on compensation phenomena. It is therefore interesting to use the ballistic tests developed to monitor the movements of athletes as a new possible indicator of the return to sport.

The main objective of this study is to evaluate the performance of ballistic tests in predicting failure to return to physical activity 24 months after ACL surgery.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient (> 18 years),
  • Patient who has undergone ACL reconstruction of the hamstrings with or without associated extra-articular plastic surgery:
  • Isolated ACL sprain without injury to the collateral ligaments or the PCL,
  • ACL reconstruction without associated meniscal injury or with repaired or menisctomized meniscal injury,
  • Having to perform a K-STARTS test and an isokinetic test,
  • Having the Tegner score before the rupture.

Exclusion criteria

  • Patient with high cardio-respiratory risk,
  • Osteoarticular and neuromuscular traumatic sequelae of the lower limbs,
  • Degenerative neuromuscular diseases,
  • Connective Tissue and Collagen Disease (e.g. Marfan),
  • Follow-up of a medical treatment that may influence the neuro-muscular system (e.g., antidepressants, etc.) during the tests,
  • Pregnant, parturient or breastfeeding patient.

Treatment and study plan

isokinetic test

Other

Bilateral strength will be measured using a Contrex ® dynamometer equipped with an exercise table. Each subject will perform isokinetic tests of the right and left knee extensors and flexors. Subjects will be stabilized by straps during testing and the joint rotation axis will be aligned with the input shaft of the dynamometer.

Ballistic test

Other

ballistic squat jumps performed in the supine position on a frictionless sled at a resistance between 0% of body weight (BW)

K-STARTS test

Other

The K-STARTS (Knee Health Athletic Return To Sport) test brings together a set of 7 tests validated in the scientific literature to assess the control and neuromuscular capacities of the lower limb when performing dynamic movements as well as apprehension when resuming activity.

Test in 30 minutes with physical exercises and questionnaire.

questionnaires

Other

KOOS (Knee Injury and Osteoarthritis Outcome Score) Questionnaire

Primary outcomes

  1. Analysis of the kinetics of force waves produced at high speed during ballistic movement

    Time frame: 24 Months

    Analysis of the kinetics of force waves produced at high speed during a ballistic movement will make it possible to determine the ability to resume physical activity at a level similar to that before the rupture in the absence of injury (risk = 2.3 / no risk = 0.1).

    Failure to resume physical activity 24 months after ACL surgery is defined by the occurrence of one of the following events:

    • Graft rupture,
    • Contralateral ACL rupture,
    • Decrease of at least 2 points in the Tegner 24 months after cruciate ligament surgery compared to the Tegner before the rupture

Secondary outcomes

  1. Return to physical activity via isokinetic test

    Time frame: 24 Months

    Fitness to resume physical activity via isokinetic test will be determined by quadriceps torque values (>3.0 Nm/kg) and an LSI>90%.

  2. Return to physical activity via the K-STARTS test

    Time frame: 24 Months

    Fitness to resume physical activity via the K-STARTS test will be determined by a total score ≥ 18 points and individual results of the tests comprising the K-START between 2 and 3.

Study contacts

Contact information is provided by the study sponsor or research team.

Arnaud HAYS, PhD

CONTACT

[email protected]

Dr Nicolas MORIN-SALVO, MD

CONTACT

[email protected]

+33 4.91.61.17.95

Sponsors and collaborators

Lead sponsor

Almaviva Sante

Other

Registry information

Official study title

Benefits of Ballistic Tests in the Decision to Return to Sport After the Ruptured Anterior Cruciate Ligament Surgery

Acronym: BALLCA

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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