Meniscal Lesions in Return to Sport After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT04129827

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-12-31

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.

Conditions

ACL Injury; Meniscus Lesion; Sport Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Clinical, self-reported psychological and biomechanical assessments

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

Intervention Type: OTHER

Other Intervention Names

CLIMB Battery

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto di Fisiologia Clinica CNR

OTHER

Sponsor Role: collaborator

University of Bari

OTHER

Sponsor Role: lead

Responsible Party

Biagio Moretti, MD

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenzo Moretti, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Locations

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, IT, Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 34126566 (View on PubMed)

Other Identifiers

5836

Identifier Type: -

Identifier Source: org_study_id