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Completed

NCT Number: NCT06319040

The Effect Of Addıtıonal Surgery On Muscle Strength, Proprıoceptıon And Balance In Anterıor Crucıate Lıgament Surgery

Meniscal tears and RAMP lesions are frequently seen together with ACL injuries. The aim of this study was to evaluate the effects of meniscus repair and RAMP lesion repair ACL reconstruction surgery in terms of muscle strength, proprioception, and balance. In our study, the clinical outcomes of both anterior cruciate ligament reconstruction (ACLR), medial meniscus repair (MR) and RAMP lesion repair (RR) have been compared with those of isolated ACLR.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Meniscus Lesion Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

Methods:

Fifteen patients of isolated ACLR performed, 15 patients of ACLR with MR or RR performed, and 15 healthy participants were included in our study. Besides, patients to whom ACLR and additional interventions performed divide into subgroups: 7 patients with RR and 8 patients with MR. Isokinetic muscle strength, proprioception, balance, fall risk, Lysholm Knee Scoring and Tegner Activity Level scale of patients were evaluated preoperatively and at the postoperative 6th week.

The data obtained in the research were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, mean, and standard deviation were used as descriptive statistical methods in the evaluation of the data. The relationship between grouped variables was tested by chi-square analysis. One-way Anova test was used to compare quantitative continuous data between more than two independent groups. Scheffe test was used as a complementary post-hoc analysis to determine the differences after the Anova test. The difference between within-group measurements was analyzed with the paired-group t-test.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being between 18 and 40 years of age, not having had any previous knee surgery and not having any diagnosis of knee pathology, not having any musculoskeletal injury, cardiopulmonary or vestibular dysfunction that would prevent performing the tests in the study were the inclusion criteria for control group.

Exclusion criteria

  • In addition to ACL injury, the patients with cartilage damage, knee arthrosis, misalignment in the lower extremity and additional ligament pathologies, history of previous knee surgery, any pathology in the opposite lower extremity, and additional neuromuscular diseases were excluded.

Treatment and study plan

Muscle Strength Measurement

Other

Muscle strength of both legs, maximal reciprocal concentric isokinetic knee extension (quadriceps) and flexion (hamstring) at 60°/s, 90°/s and 180°/s speeds were evaluated

Knee joint proprioception

Other

Knee joint proprioception was assessed by joint position sense. Joint position sense was measured by the previously taught ability to actively find joint position (EPAB)

balance

Other

The patients and healthy individuals participating in our study were evaluated with the General Stability Index (GSI) for general balance ability, Anterior-Posterior Stability Index (APSI) for anterior-posterior balance ability, Medial-Lateral Stability Index (MLSI) for lateral balance ability and Fall Risk Index (DRI) and Biodex Balance System (Biodex Inc., Shirley, New York, USA) for fall risk. High values obtained indicate deterioration in balance and increased risk of falling.

Fall risk test

Other

Biodex Balance System (Biodex Inc., Shirley, New York, USA) for fall risk

Tegner Activity Level

Other

Tegner Activity Level and the Turkish version of the Lysholm Knee Scoring Scale by Çelik et al. were used to subjectively determine the functional level in individuals undergoing ACL reconstruction surgery.

Lysholm Knee Scoring Scale

Other

Tegner Activity Level and the Turkish version of the Lysholm Knee Scoring Scale by Çelik et al. were used to subjectively determine the functional level in individuals undergoing ACL reconstruction surgery.

Primary outcomes

  1. muscle strength measurement

    Time frame: 30 minutes

    The isokinetic system (Cybex NORM®, Humac, CA, USA) was used to assess muscle strength measurement. Subjects sat upright on the dynamometer chair with 90˚ hip flexion during measurement. The axis of rotation of the dynamometer was adjusted to align with the anatomical axis of the knee joint (lateral condyle of the femur). To prevent compensatory movements during the test, participants were fixed on both shoulders, waist, and thighs. The belt used for the tested extremity was placed 3 cm proximal to the malleolus. Both verbal and visual feedback was given for individuals to participate in the test with maximum effort

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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