Benefits of Ballistic Tests After the Anterior Cruciate Ligament Surgery (BALLCA)

Benefits of Ballistic Tests in the Decision to Return to Sport After the Ruptured 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Other: isokinetic test; Other: Ballistic test; Other: K-STARTS test; Other: Questionnaires

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Nicolas MORIN-SALVO, MD; Phone Number: +33 4.91.61.17.95; Email: n.morin-salvo@live.fr
• Study Contact Backup: Name: Arnaud HAYS, PhD; Email: arnaud.hays@univ-amu.fr

Study Locations

• France
  • Marseille, France, 13012
    • Clinique Chantecler
    • Contact: Dr Nicolas MORIN-SALVO, MD; Phone Number: +33 4.91.61.17.95; Email: n.morin-salvo@live.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patient underwent ACL reconstruction

Other: isokinetic test; 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.; Other: Ballistic test; ballistic squat jumps performed in the supine position on a frictionless sled at a resistance between 0% of body weight (BW); Other: K-STARTS test; 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.; Other: Questionnaires; KOOS (Knee Injury and Osteoarthritis Outcome Score) Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of the kinetics of force waves produced at high speed during ballistic movement	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	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to physical activity via isokinetic test	Fitness to resume physical activity via isokinetic test will be determined by quadriceps torque values (>3.0 Nm/kg) and an LSI>90%.	24 Months
Return to physical activity via the K-STARTS test	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.	24 Months

Collaborators and Investigators

• Sponsor: Almaviva Sante

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Rupture
• Other Study ID Numbers: 2023-03; ID-RCB number: 2024-A01538-39 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No