NCT06524869

Brief Summary

The anterior cruciate ligament (ACL) injury is common in athletes aged 18 to 35. ACL reconstruction (ACLR) aims to restore knee stability in the process of returning to sports. Post-surgical rehabilitation focuses on optimizing biomechanical parameters, with neuromuscular and functional tests assessing muscle strength, proprioception, and dynamic stability. Isokinetic allows the measurement of muscle strength symmetry and proprioception, while the single-leg hop and landing tasks assess functional stability and are predictive of sports resumption and injury prevention. Despite progress, concerns remain about neuromuscular factors impacting knee stability, especially during landings, which can increase the risk of secondary ACL injuries. This study proposes examining knee strength and proprioception using isokinetic dynamometry, alongside biomechanical assessments from functional tests, to explore their relationship to biomechanical features during landings, at 6-to-12 months post-ACL reconstruction. The hypothesis is that better muscle strength and proprioception correlate with improved knee control during landing tasks.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 24, 2024

Last Update Submit

July 24, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Passive proprioceptive evaluation

    Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.

    One measurement during the visit at 6 to 12 months after surgery

  • Strength

    Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.

    One measurement during the visit at 6 to 12 months after surgery

  • Single Hop test

    Measurement of knee position during landing from a single leg hop task

    One measurement during the visit at 6 to 12 months after surgery

  • Single-leg landing task

    Measurement of knee position during landing from a 30-cm box

    One measurement during the visit at 6 to 12 months after surgery

Secondary Outcomes (3)

  • Single Hop for Distance

    One measurement during the visit at 6 to 12 months after surgery

  • ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)

    One measurement during the visit at 6 to 12 months after surgery

  • Landing Error Scoring System (LESS)

    One measurement during the visit at 6 to 12 months after surgery

Study Arms (1)

ACL reconstruction group

All sports patients who had a muscle evaluation at 6 to 12 months after ACLR since March 2024

Diagnostic Test: Isokinetic neuromuscular assessment

Interventions

All sports patients who had a muscle evaluation in addition to functional testing at 6-12 months after ACLR since March 2024

ACL reconstruction group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All sports patients included in the sport medicine follow-up protocole with isokinetic muscular assessment at 6-12 months after ACL reconstruction surgery since March 2024 in the sports medicine department (Return To Sport Process)

You may qualify if:

  • Adult patients, aged 18-40, who have undergone a first ACL reconstruction more than 6 months ago and are being followed in a sports medicine care pathway
  • Affiliated with a health insurance plan
  • Information form: Non-objection to the use of data for research purposes

You may not qualify if:

  • Previous ligament surgery of the lower limbs prior to ACL reconstruction
  • Complex ligament injury (lateral ligaments, posterior cruciate ligament)
  • Recent muscle injuries
  • History of injury to the uninjured knee
  • Pregnant woman
  • Neurological history with residual effects or taking medication that affects balance/coordination
  • Inability to perform a muscular assessment
  • Postoperative complications (deep vein thrombosis, sepsis, stiffness/arthrofibrosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen Normandie

Caen, 14000, France

RECRUITING

Related Publications (1)

  • Faivre O, Prum G, Hulet C, Drigny J. Improved hamstring strength and knee position sense are associated with enhanced landing mechanics after anterior cruciate ligament reconstruction. J ISAKOS. 2025 Jun;12:100858. doi: 10.1016/j.jisako.2025.100858. Epub 2025 Apr 5.

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 24, 2024

First Posted

July 29, 2024

Study Start

March 10, 2024

Primary Completion

July 24, 2024

Study Completion

August 30, 2024

Last Updated

July 29, 2024

Record last verified: 2024-07

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