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

May 18, 2022 updated by: Özgül Öztürk, Acibadem University
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.

Study Overview

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Marmara University Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who were underwent remnant-preserving anterior cruciate ligament reconstruction

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anterior Cruciate Ligament Reconstruction
Proprioception assessment, functionality assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

May 5, 2022

Study Completion (Actual)

May 10, 2022

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK 2021 / 16

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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