Meniscal Lesions in Return to Sport After Anterior Cruciate Ligament Reconstruction

NCT04129827 | Completed

• 1 other identifier: 5836
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Injury; Meniscus Lesion; Sport Injury

Keywords

Return to Sport; ACL reconstruction; Knee; Athletes

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Odds ratio between presence of ML and CLIMB-based criteria

  18-months

Interventions

Clinical, self-reported psychological and biomechanical assessments OTHER

1. medical check up * active and passive Range Of Motion (ROM) * anterior drawer test * knee's alignment * modified cincinnati rating system questionnaire (mCRSQ) * tegner lysholm knee scoring scale (TLKS) * Tegner Activity Level Score (TALS) 2. self-reported psychological questionnaires * Tampa Scale of Kinesiophobia (TSK) * ACL Return to Sport after Injury (ACL-RSI) score 3. biomechanical tests * Stability test: to balance on one/two legs on a free to move disc for 30s * Jump test: i) a maximize jump with both legs; ii) a maximize jump with only one leg; three consecutive jumps; iv) jump coordination path where the patient had to perform a forward-backward-forward jump and a sideway jump on one leg * Coordination test: a square hurdle was used for the quick test, where the patient had to step in and out with both feet for a total of 15-rep as quickly as possible * fatigue test: to rise and sit from a chair for 30-rep as quickly and safely as possible

Also known as: CLIMB Battery

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bari: lead
• Istituto di Fisiologia Clinica CNR: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, IT, 70124, Italy

Location

Related Publications (1)

• 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.

  PMID: 34126566 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Lorenzo Moretti, MD

  Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 17, 2019
• Study Start: July 1, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 31, 2019
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

IT (1)