Anterior Cruciate Ligament InjuriesBALLCANCT06720649
Benefits of Ballistic Tests After the Anterior Cruciate Ligament Surgery
A study testing isokinetic test, Ballistic test and K-STARTS test in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Almaviva Sante at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
- What is being tested?
- isokinetic test, Ballistic test and K-STARTS test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2024to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arnaud HAYS, PhD contact
France1 site
Clinique Chantecler
Marseille, 13012
Dr Nicolas MORIN-SALVO, MD, +33 4.91.61.17.95, n.morin-salvo@live.fr
About this study
Official title: 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.
Read more
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.
- Being tested
- isokinetic test, Ballistic test, K-STARTS test, Questionnaires
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isokinetic testOther
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 testOther
ballistic squat jumps performed in the supine position on a frictionless sled at a resistance between 0% of body weight (BW)
K-STARTS testOther
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.
QuestionnairesOther
KOOS (Knee Injury and Osteoarthritis Outcome Score) Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| patient underwent ACL reconstruction | Experimental | Not described Receives: Other: isokinetic test; Other: Ballistic test; Other: K-STARTS test; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Months
Secondary outcomes (2)
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%.
Measured: 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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almaviva Sante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720649
- Sponsor's protocol ID
- 2023-03
- Other IDs
- ID-RCB number: 2024-A01538-39
- Acronym
- BALLCA
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Ballistic Tests in the Decision to Return to Sport After the Ruptured Anterior Cruciate Ligament Surgery
- ClinicalTrials.gov ID
- NCT06720649
- Acronym / sponsor ID
- BALLCA / 2023-03
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Almaviva SanteUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient underwent ACL reconstruction | Experimental | Other: isokinetic test, Other: Ballistic test, Other: K-STARTS test, Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient (> 18 years),
- Patient who has undergone ACL reconstruction of the hamstrings with or without associated extra-articular plastic surgery:
- Having to perform a K-STARTS test and an isokinetic test,
- Having the Tegner score before the rupture.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isokinetic testBilateral 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 | patient underwent ACL reconstruction |
| Ballistic testballistic squat jumps performed in the supine position on a frictionless sled at a resistance between 0% of body weight (BW) | Other | patient underwent ACL reconstruction |
| K-STARTS testThe 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 | patient underwent ACL reconstruction |
| QuestionnairesKOOS (Knee Injury and Osteoarthritis Outcome Score) Questionnaire | Other | patient underwent ACL reconstruction |
Primary outcome
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
2 secondary outcomes
Return to physical activity via isokinetic test
Time frame: 24 Months
Return to physical activity via the K-STARTS test
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injuries
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnaud HAYS, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isokinetic test, Ballistic test and K-STARTS test in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Almaviva Sante at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Nicolas MORIN-SALVO, MD (+33 4.91.61.17.95, n.morin-salvo@live.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the kinetics of force waves produced at high speed during ballistic movement (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.