Comparison of Remnant-Preserving Anterior Cruciate Ligament Reconstruction With Healthy Controls

Comparison of Patients Who Had Remnant-Preserving Anterior Cruciate Ligament Reconstruction With Healthy Controls In Terms of Muscle Strength and Proprioception

Anterior cruciate ligament reconstruction stabilizes the knee joint biomechanically and returns the patients back to the sportive activities. Numerous techniques exist to perform an anterior cruciate ligament reconstruction surgery. Remnant- preserving reconstruction technique is performed to increase surgery success rates and to accelerate the post-surgical return to sport process. In general, there is no consensus regarding the clinical outcomes of remnant-preserving anterior ligament reconstruction over standart procedure. The purpose of this study is to compare the patients who had remnant-preserving anterior cruciate ligament reconstruction with healthy controls in terms of muscle strength and proprioception.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Other: Assessments

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Özgül Öztürk, PhD; Phone Number: 902165004185; Email: ozgul.ozturk@acibadem.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Marmara University
  • Istanbul, Turkey
    • Recruiting
    • Acıbadem Mehmet Ali Aydınlar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who had remnant-preserving ACL reconstruction and healthy controls

Description

Inclusion Criteria:

• Anatomical single-bundle ACL reconstruction with AM portal technique using hamstring autograft due to full-thickness ACL tear,
• Endobutton technique was used for femoral fixation,
• Not having any trauma or surgery on the opposite knee,
• Patients with a follow-up period of at least 12 months after surgery.

Exclusion Criteria:

• Fracture of lower extremity accompanying anterior cruciate ligament tear; posterior cruciate ligament, inner and outer lateral ligament tears,
• Patients who have undergone previous surgery on the knee to be evaluated,
• Cases with repeated anterior cruciate ligament reconstruction,
• Having a history of knee joint arthritis (osteoarthritis, inflammatory arthritis),
• Cases with neurological disease will be excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anterior Cruciate Ligament Reconstruction; Patients who had remnant-preserving anterior cruciate ligament reconstruction	Other: Assessments; Muscle Strength, Proprioception, Kinesiophobia
Healthy Group; People who had no knee surgery or injury	Other: Assessments; Muscle Strength, Proprioception, Kinesiophobia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isokinetic muscle strength	Isokinetic muscle strength values of the Quadriceps Femoris and Hamstring muscles in the knee joint will be measured using the Biodex® System Pro 4 (Biodex Cor. Shirley NY, USA) device. Subjects will perform a warm-up exercise for the knee joint at 75 pedal cycles per minute for three minutes on a bicycle ergometer prior to testing. After the warm-up exercises, the subjects will be allowed to rest for 10 minutes. Subjects will be seated on the isokinetic device chair with their backs perpendicular to 90º. Concentric isokinetic muscle strength measurements of the affected side and unaffected side quadriceps femoris and hamstring muscles of the subjects will be performed with 5 repetitions at 180º /sec, 240º /sec, 300º /sec after the torso, pelvic and thigh belts are attached. Between tests, subjects will be allowed to rest for one minute each. The peak torque values of the cases will be recorded in Nm.	1 day
Proprioception	Biodex® System Pro 4 (Biodex Cor. Shirley NY, USA) device will be used to evaluate the proprioception sensation of the knee joint. The subjects will be asked to sit on the isokinetic dynamometer device with the knee joint in 90º flexion. The sense of proprioception of the operated and non-operated knees will be measured at three different angles of 20º, 50º and 70º. During the test, the target angle will be displayed by the device and the limb will be held in this position for 10 seconds. Then, returning to the starting point, the subject will be asked to actively find the target angle with eyes closed. The scores will be averaged by repeating the measurements three times for each reference angle. A rest period of 3 minutes will be allowed between different reference angles.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinesiophobia	The level of fear of movement of the participants will be evaluated with the Tampa Kinesiophobia Scale which is a 17-item scale developed to measure fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear and avoidance in work-related activities. The scale evaluates fear of movement with a 4-point Likert-type scoring system (1= Strongly disagree, 4= Totally agree). While the total score is determined between 17-68, a higher score means that the fear of movement is greater.	1 day

Collaborators and Investigators

• Sponsor: Acibadem University
• Collaborators: Marmara University; Haydarpasa Numune Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ANTICIPATED): April 30, 2023
• Study Completion (ANTICIPATED): April 30, 2023

Study Registration Dates

• First Submitted: February 6, 2022
• First Submitted That Met QC Criteria: February 6, 2022
• First Posted (ACTUAL): February 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: ATADEK 2021/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No