Benefits of Ballistic Tests After the Anterior Cruciate Ligament Surgery

NCT06720649 | Not Yet Recruiting

• 2 other identifiers: 2023-03ID-RCB number: 2024-A01538-39
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Return to physical activity via isokinetic test

  24 Months

• Return to physical activity via the K-STARTS test

  24 Months

Study Arms (1)

patient underwent ACL reconstruction

EXPERIMENTAL

Other: isokinetic test; Other: Ballistic test; Other: K-STARTS test; Other: Questionnaires

Interventions

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.

patient underwent ACL reconstruction

Ballistic test OTHER

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

patient underwent ACL reconstruction

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.

patient underwent ACL reconstruction

Questionnaires OTHER

KOOS (Knee Injury and Osteoarthritis Outcome Score) Questionnaire

patient underwent ACL reconstruction

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Almaviva Sante: lead

Study Sites (1)

Clinique Chantecler

Marseille, 13012, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Dr Nicolas MORIN-SALVO, MD

CONTACT

+33 4.91.61.17.95; n.morin-salvo@live.fr

Arnaud HAYS, PhD

CONTACT

arnaud.hays@univ-amu.fr

Study Design

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

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): June 15, 2028
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)