Clinical trial NCT04129827: Meniscal Lesions in Return to Sport After Anterior Cruciate Ligament Reconstruction
Official title: Retrospective Cohort Study on How Meniscal Lesions Affect Return to Sport After Anterior Cruciate Ligament Reconstruction in Young Non-professional Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACL Injury
Meniscus Lesion
Sport Injury
Keywords: Return to Sport
ACL reconstruction
Knee
Athletes
Lead sponsor: University of Bari
Sponsor class: OTHER
Collaborators: name: Istituto di Fisiologia Clinica CNR
First posted: 2019-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients has been enrolled according to the eligible criteria in Orthopaedic and Trauma Unit of University Hospital of Bari

Brief summary: Most athletes who undergo Anterior Cruciate Ligament Reconstruction (ACLR) plan to return to some level of sporting (RTS) activity. However, rates of return to pre-injury sport are often less than might be expected and many factors influence whether individuals return to sport after this surgery. This study aims to better understand the role of meniscal lesions in RTS and to assess the advantage of the integrated evaluation with clinical, biomechanical and psychological tests to decide the correct RTS timing in non-professional athletes undergoing ACLR.

Detailed description: Twenty non-professional athletes with acute ACL injury were recruited in the Orthopaedic and Trauma Unit of University Hospital of Bari. All the patients underwent an all-inside semitendinosus (ST) tendon autograft ACLR with Arthrex TightRope cortical fixation.

The clinical outcomes (modified Cincinnati Rating System Questionnaire (mCRSQ), Tegner Activity Level Score (TALS), Tegner Lysholm Knee Scoring Scale (TLKSS)), the self-reported psychological scores (Tampa Scale of Kinesiophobia (TSK) and the ACL Return to Sport after Injury (ACL-RSI) score) and biomechanical outcomes (stability, jump, coordination and fatigue tests) were assessed postoperatively at 18 months.

Eligibility criteria: Inclusion Criteria:

* aged 18-35 years old
* non professional athletes
* ACLR between January 2017 and December 2017
* all-inside semitendinosus (ST) tendon autograft ACLR with Arthrex TightRope cortical fixation

Exclusion Criteria:

* diabetes
* BMI \> 30 kg/m2
* heart disease

Primary outcomes:
measure: Correlation between TSK, ACL-RSI Score and mCRSQ Score
timeFrame: 18-months
measure: Correlation between clinical and psychological features
timeFrame: 18-months
measure: Association between clinical features and level of stability
timeFrame: 18-months
measure: Association between clinical features and limb symmetry index
timeFrame: 18-months
measure: Association between clinical features and Coordination Time
timeFrame: 18-months
Secondary outcomes:
measure: Odds ratio between presence of ML and CLIMB-based criteria
timeFrame: 18-months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
state: IT
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
name: Lorenzo Moretti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bortone I, Moretti L, Bizzoca D, Caringella N, Delmedico M, Piazzolla A, Moretti B. The importance of biomechanical assessment after Return to Play in athletes with ACL-Reconstruction. Gait Posture. 2021 Jul;88:240-246. doi: 10.1016/j.gaitpost.2021.06.005. Epub 2021 Jun 8.