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

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05057442
• Other study ID #: ATADEK 2021 / 16
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: May 10, 2022

Study information

• Verified date: May 2022
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 10, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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,

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Other:
• Proprioception assessment, functionality assessment
Proprioception assessment, functionality assessment

Locations

Country	Name	City	State
Turkey	Marmara University Department of Physiotherapy and Rehabilitation	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Acibadem University	Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proprioception assessment	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
Primary	The Lysholm Score	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
Primary	Single Leg Hop Test	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