NCT05245461

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

2 active sites

Status
unknown

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

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

February 6, 2022

Last Update Submit

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

Other: Assessments

Healthy Group

People who had no knee surgery or injury

Other: Assessments

Interventions

Muscle Strength, Proprioception, Kinesiophobia

Anterior Cruciate Ligament ReconstructionHealthy Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

Study Sites (2)

Acıbadem Mehmet Ali Aydınlar University

Istanbul, Turkey (Türkiye)

RECRUITING

Marmara University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Özgül Öztürk, PhD

CONTACT

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

Locations