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Completed

NCT Number: NCT05057442

The Effects of Remnant-Preserving Anterior Cruciate Ligament Reconstruction on Proprioception and Functionality

Anterior cruciate ligament (ACL) reconstruction is a frequently performed surgical procedure to stabilize the knee joint biomechanically. At the same time, one of the goals is to improve clinical outcomes and return the patient to their daily life as early and ready as possible, as well as to sports activities. Remnant-preserving anterior cruciate ligament reconstruction is one of the reconstruction approaches that aim to achieve these goals earlier and more safely than the standard surgical procedure. However, there is no consensus in the literature regarding the effects of remnant-preserving ACL reconstruction on clinical outcomes and its superiority over the standard surgical procedure. Therefore, the aim of our study is to compare the proprioception and functionality of patients who underwent ACL reconstruction with the remnant-preserving approach, by classifying them according to stump size.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Department of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged between 18 - 45 years,
  • Anatomical single-bundle ACL reconstruction with antero-medial portal technique using hamstring autograft due to a full-thickness ACL tear,
  • Endobutton technique was used for femoral fixation,
  • Has not had any trauma or surgery on the non-operated knee,
  • Patients with a follow-up period of at least 12 months after surgery.

Exclusion criteria

  • Fracture of lower extremity, posterior cruciate ligament, inner and outer lateral ligament tears accompanying anterior cruciate ligament tear,
  • Patients who have undergone previous surgery on the targeted knee,
  • Have a revision anterior cruciate ligament reconstruction,
  • Having a history of knee joint arthritis (osteoarthritis, inflammatory arthritis),
  • Have a neurological disease,

Treatment and study plan

Proprioception assessment, functionality assessment

Other

Proprioception assessment, functionality assessment

Primary outcomes

  1. Proprioception assessment

    Time frame: 1 day

    Biodex® System Pro 4 (Biodex Cor. Shirley NY, USA) device will be used to evaluate the proprioception of the knee joint. The subjects will be asked to sit on the isokinetic dynamometer device with the knee joint in 90º flexion. The proprioception sense of the operated and non-operated knees will be measured at three different angles of 20º, 50º and 70º. Before the test, the procedures during the test such as knee flexion-extension, target angle and target angle recall will be assessed when eyes are open and closed. The test will be explained and actively demonstrated to all subjects before starting the assessment. During the test, the target angle will be displayed by the device and the limb will be held in this position for 10 seconds.

  2. The Lysholm Score

    Time frame: 1 day

    The Lysholm Scale is used to evaluate the functionality of the knee joint, has a score between 0 and 100 points. In this scoring system, a higher score indicates a better functionality.

  3. Single Leg Hop Test

    Time frame: 1 day

    Single leg forward hop test will be used to determine the functional performance level of the patient depending on the dynamic stability of the knee. The participant will be asked to stand on the leg to be tested at the starting point of the tape measure, whose toes are fixed to the floor, and to jump forward and as far as possible on the leg to be tested, along the tape measure line without losing balance. If the balance is disturbed and the foot touches the ground, the test will be repeated. There will be a one-time trial to learn the test. The test will be repeated 3 times with a 30-second rest period in between.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Collaborators

  • Marmara University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2021
Registry last updated
May 20, 2022

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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