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
1 other identifier
observational
60
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 6, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedNovember 14, 2022
November 1, 2022
1.2 years
February 6, 2022
November 10, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Kinesiophobia
1 day
Study Arms (2)
Anterior Cruciate Ligament Reconstruction
Patients who had remnant-preserving anterior cruciate ligament reconstruction
Healthy Group
People who had no knee surgery or injury
Interventions
Muscle Strength, Proprioception, Kinesiophobia
Eligibility Criteria
Patients who had remnant-preserving ACL reconstruction and healthy controls
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acibadem Universitylead
- Haydarpasa Numune Training and Research Hospitalcollaborator
- Marmara Universitycollaborator
Study Sites (2)
Acıbadem Mehmet Ali Aydınlar University
Istanbul, Turkey (Türkiye)
Marmara University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 6, 2022
First Posted
February 18, 2022
Study Start
February 1, 2022
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
November 14, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share