Meniscal Lesions in Return to Sport After Anterior Cruciate Ligament Reconstruction (LCA-40)

Retrospective Cohort Study on How Meniscal Lesions Affect Return to Sport After Anterior Cruciate Ligament Reconstruction in Young Non-professional Athletes

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.

Study Overview

• Status: Completed
• Conditions: Sport Injury; ACL Injury; Meniscus Lesion
• Intervention / Treatment: Other: Clinical, self-reported psychological and biomechanical assessments

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • IT
    • Bari, IT, Italy, 70124
      • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between TSK, ACL-RSI Score and mCRSQ Score	Tampa Scale of Kinesiophobia is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement. ACL Return to Sport after Injury measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each. It is considered that for a normal population without knee condition, the score is between 80 and 90%. modified Cincinnati Rating System Questionnaire has been designed to give your therapist information as to how your knee pain has affected your ability to manage in everyday life. It consists of 12 questions, 8 of which are included in the summary score. The total score is calculated as the sum of all questions responses, with 100 representing the best/excellent knee function, and 0 representing the worst/poor knee function.	18-months
Correlation between clinical and psychological features	Clinical assessment consist of three tests carried on during medical check-up: i) active and passive Range Of Motion (ROM); ii) anterior drawer test; iii) knee's alignment. All these measurements will be transformed in categorical variables in order to perform chi square test.	18-months
Association between clinical features and level of stability	Clinical assessment consist of three tests carried on during medical check-up: i) active and passive Range Of Motion (ROM); ii) anterior drawer test; iii) knee's alignment. All these measurements will be transformed in categorical variables. During the stability test, the patient stands with one and two legs respectively on a free to move balance disc for 30 seconds. Subjects were instructed to stand in the centre with their arms at their sides. Level of stability is defined as an index ranking from 1 (low stability) to 5 (high stability). Eta square between categorical variables from clinical assessment and the measure outcomes of biomechanical assessment will be performed.	18-months
Association between clinical features and limb symmetry index	Clinical assessment consist of three tests carried on during medical check-up: i) active and passive Range Of Motion (ROM); ii) anterior drawer test; iii) knee's alignment. All these measurements will be transformed in categorical variables. During jump tests, the subject carried a belt around their hips, and the sensor was placed above the greater trochanter of the hip. Before jumping, the subject had to stand in an upright and still position. A sequence of four different jumps has been executed. The limb symmetry index (LSI) was calculated by dividing the measured value of the injured leg by the value of the non-affected side and multiplying by 100. Eta square between categorical variables from clinical assessment and the time required to perform the test will be calculated.	18-months
Association between clinical features and Coordination Time	Clinical assessment consist of three tests carried on during medical check-up: i) active and passive Range Of Motion (ROM); ii) anterior drawer test; iii) knee's alignment. All these measurements will be transformed in categorical variables. The subject performed one-footed jumps through the course of red (forward-backward-forward jumps) and blue (sideway jumps) hurdles, completing 16 jumps. This had to be performed as quickly as possible by jumping on one leg without a rest between the hurdles. Eta square between categorical variables from clinical assessment and the time required to perform the test will be calculated.	18-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Odds ratio between presence of ML and CLIMB-based criteria	The CLIMB battery is the combination of biomechanical, clinical and psychological criteria which could allow to return to sport with the lowest possible risk of reinjury. After performing a correlation matrix and calculating collinearity using linear regression, we will calculate odds ratio as measure of association for presence-absence of meniscal lesion in the observed cohort.	18-months

Collaborators and Investigators

• Sponsor: University of Bari
• Collaborators: Istituto di Fisiologia Clinica CNR
• Investigators: Principal Investigator: Lorenzo Moretti, MD, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Knee; ACL reconstruction; Athletes; Return to Sport
• Additional Relevant MeSH Terms: Leg Injuries; Knee Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries; Athletic Injuries
• Other Study ID Numbers: 5836

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No