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

NCT ID: NCT06319040

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-06

Study Completion Date

2019-06-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anterior Cruciate Ligament Injuries Meniscus Lesion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group 1

15 patients who underwent isolated ACLR

Muscle strength measurement

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Tegner Activity Level

Intervention Type 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

Intervention Type 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.

Study Group 2

15 patients who underwent ACLR with additional intervention

Muscle strength measurement

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Tegner Activity Level

Intervention Type 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

Intervention Type 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.

Control Group

15 healthy individuals

Muscle strength measurement

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Tegner Activity Level

Intervention Type 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

Intervention Type 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.

Interventions

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Muscle strength measurement

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

Intervention Type OTHER

Knee joint proprioception

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)

Intervention Type OTHER

Balance

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.

Intervention Type OTHER

Fall risk test

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

Intervention Type OTHER

Tegner Activity Level

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.

Intervention Type OTHER

Lysholm Knee Scoring Scale

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Tugba Turk Kalkan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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tuğba türk kalkan, MD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

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Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Gulenc B, Kemah B, Yalcin S, Sayar S, Korkmaz O, Erdil M. Surgical Treatment of Meniscal RAMP Lesion. J Knee Surg. 2020 Mar;33(3):255-259. doi: 10.1055/s-0039-1677887. Epub 2019 Mar 8.

Reference Type BACKGROUND
PMID: 30849785 (View on PubMed)

Other Identifiers

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MEDİPOL MEGA 1

Identifier Type: -

Identifier Source: org_study_id

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