Meniscal Lesions in Return to Sport After Anterior Cruciate Ligament Reconstruction

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 35 years
• All sexes
• Healthy volunteers accepted
• Adult

Study population: All the patients has been enrolled according to the eligible criteria in Orthopaedic and Trauma Unit of University Hospital of Bari

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

ACL Injury, Meniscus Lesion, Sport Injury

Being tested

Clinical, self-reported psychological and biomechanical assessments

Keywords

Return to Sport, ACL reconstruction, Knee, Athletes

Medical subject headings

Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Clinical, self-reported psychological and biomechanical assessmentsOther

  Also called CLIMB Battery

  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)

  1. self-reported psychological questionnaires

  • Tampa Scale of Kinesiophobia (TSK)
  • ACL Return to Sport after Injury (ACL-RSI) score

  1. 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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: 18-months

2. 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.

   Measured: 18-months

3. 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.

   Measured: 18-months

4. 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.

   Measured: 18-months

5. 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.

   Measured: 18-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted17 Oct 2019
2. Study start1 Jul 2018
3. Primary completion21 Dec 2018
4. Study completion31 Dec 2019

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for ACL InjuryStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.