Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament

Ligament Injury Clinical Trial

Official title:

Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050005
• Other study ID #: Universidade da Coruña
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: September 2023
• Source: Universidade da Coruña
• Contact: Sérgio Loureiro Nuno, MSc
• Phone: 00351911713133
• Email: sergio.nuno[@]udc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anterior cruciate ligament (ACL) injuries are recurrent, especially in sports. There is still no consensus on the characterization of functional indicators in this clinical condition, as well as their correlation with measuring instruments and clinical functional tests. It is intended to study the changes in functionality of users undergoing this surgery, aiming with functional assessment scales at different times of recovery. This will allow deciding on more adapted recovery strategies, which can meet the musculoskeletal requirements of the user.

Description:

It is proposed to carry by carrying out quasi-experimental, quantitative and analytical studies. The sample will consist of athletes who have started recovering from ACL surgery and who meet the previously established inclusion and exclusion criteria. The study will use and compare functional tests (Star Excursion Balance Test, Lateral Step Down Test and Weight-Bearing Lunge Test) with measurement instruments: Knee and Osteoarthritis Outcome Score (KOOS), Lyshom Knee Scoring Scale, Lower Extremity Functional Score (LEFS), Return to Sport After Injury Scale (ACL-RSI) and IKDC Subjective Knee Evaluation Form. The intervention will be performed on individual athletes who have had anterior cruciate ligament injury for the first time or recurrence of this ligament in the same knee or injury in the contralateral knee.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Start of physiotherapy in the preoperative context and continuation of recovery up to 2 weeks after surgery; age equal to or greater than 18 years; With or without meniscal injury; Be able to correctly fill in the assessment instruments and complete the Informed Consent Form;

Exclusion Criteria:

• Concomitant bilateral injury/history of surgery or contralateral dysfunction; meniscal suture; cartilaginous injury; injury to the internal lateral ligament, external lateral ligament and posterior cruciate ligament; concomitant intra and extra-articular plastic surgery; individuals with recent heart disease, intermittent claudication, neuropathies and cognitive alterations.

Related Conditions & MeSH terms

• Ligament Injury
• Ligament Rupture
• Rupture

Intervention

Diagnostic Test:
• Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.
The protocol is based on the ligamentization stages, since the bibliography relates the ligamentization process with rehabilitation. These stages are necrosis, revascularization, cellular priorities and collagen formation, and different care is required for each stage. Taking these aspects into account, the authors developed recommendations to establish a protocol divided by the evaluation phases of the present work. Users should only move on to the next phase if they achieve the expected results, or that makes the total duration of each protocol vary from user to user. tests and scales will be evaluated before surgery, after 6 weeks of surgery and at the end of treatment.

Locations

Country	Name	City	State
Portugal	Clínica São João de Deus	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Universidade da Coruña

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic balance	Change from baseline in a functional test - Y Balance Test - The test should be performed in the following order: Right Anterior, Left Anterior, Right Posteromedial, Left Posteromedial, Right Posterolateral.; Left Posterolateral	1 day before ACL reconstruction surgery
Primary	Dynamic balance	Change from baseline in a functional test - Y Balance Test	At 6 weeks after ACL reconstruction surgery.
Primary	Dynamic balance	Change from baseline in a functional test - Y Balance Test	At 12 weeks after ACL reconstruction surgery.
Primary	Dynamic balance	Change from baseline in a functional test - Y Balance Test	At 24 weeks after ACL reconstruction surgery.
Primary	Dynamic knee stability	Hop test. In this test, the aim is to jump as far as possible with both legs, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg.	At 12 weeks after ACL reconstruction surgery.
Primary	Dynamic knee stability	Single hop test. In this test, the aim is to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb.	At 24 weeks after ACL reconstruction surgery.
Primary	The International Knee Documentation Committee (IKDC) score	The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.	1 day before ACL reconstruction surgery
Primary	The International Knee Documentation Committee (IKDC) score	The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.	At 6 weeks after ACL reconstruction surgery.
Primary	The International Knee Documentation Committee (IKDC) score	The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.	At 12 weeks after ACL reconstruction surgery.
Primary	The International Knee Documentation Committee (IKDC) score	The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.	At 24 weeks after ACL reconstruction surgery.
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	The dimensions from this scale are divided into 5 items (Symptoms, Pain, Activities of Daily Living, Sports and Leisure Activities and Quality of Life) on a positive orientation scale from 0 (extreme knee problems) to 100 (no knee problems).	1 day before ACL reconstruction surgery
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	The dimensions from this scale are divided into 5 items (Symptoms, Pain, Activities of Daily Living, Sports and Leisure Activities and Quality of Life) on a positive orientation scale from 0 (extreme knee problems) to 100 (no knee problems).	At 6 weeks after ACL reconstruction surgery.
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	The dimensions from this scale are divided into 5 items (Symptoms, Pain, Activities of Daily Living, Sports and Leisure Activities and Quality of Life) on a positive orientation scale from 0 (extreme knee problems) to 100 (no knee problems).	At 12 weeks after ACL reconstruction surgery.
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	The dimensions from this scale are divided into 5 items (Symptoms, Pain, Activities of Daily Living, Sports and Leisure Activities and Quality of Life) on a positive orientation scale from 0 (extreme knee problems) to 100 (no knee problems).	At 24 weeks after ACL reconstruction surgery.
Primary	Lysholm Rating Scale	This scale consists of eight items. It is scored on a scale of 0 to 100 with higher scores indicating fewer symptoms and higher levels of functioning.	1 day before ACL reconstruction surgery
Primary	Lysholm Rating Scale	This scale consists of eight items. It is scored on a scale of 0 to 100 with higher scores indicating fewer symptoms and higher levels of functioning.	At 6 weeks after ACL reconstruction surgery.
Primary	Lysholm Rating Scale	This scale consists of eight items. It is scored on a scale of 0 to 100 with higher scores indicating fewer symptoms and higher levels of functioning.	At 12 weeks after ACL reconstruction surgery.
Primary	Lysholm Rating Scale	This scale consists of eight items. It is scored on a scale of 0 to 100 with higher scores indicating fewer symptoms and higher levels of functioning.	At 24 weeks after ACL reconstruction surgery.
Primary	Lower Extremity Functional Scale (LEFS)	This measurement instrument consists of 20 items, each of which is scored on a scale five points, from zero to four. The total LEFS score, with a minimum value of zero - low functional level - and maximum of 80 - high functional level, which can be exposed in percentage terms.	1 day before ACL reconstruction surgery
Primary	Lower Extremity Functional Scale (LEFS)	This measurement instrument consists of 20 items, each of which is scored on a scale five points, from zero to four. The total LEFS score, with a minimum value of zero - low functional level - and maximum of 80 - high functional level, which can be exposed in percentage terms.	At 6 weeks after ACL reconstruction surgery.
Primary	Lower Extremity Functional Scale (LEFS)	This measurement instrument consists of 20 items, each of which is scored on a scale five points, from zero to four. The total LEFS score, with a minimum value of zero - low functional level - and maximum of 80 - high functional level, which can be exposed in percentage terms.	At 12 weeks after ACL reconstruction surgery.
Primary	Lower Extremity Functional Scale (LEFS)	This measurement instrument consists of 20 items, each of which is scored on a scale five points, from zero to four. The total LEFS score, with a minimum value of zero - low functional level - and maximum of 80 - high functional level, which can be exposed in percentage terms.	At 24 weeks after ACL reconstruction surgery.
Primary	Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)	It is a specific 12-item questionnaire assessing the psychological impact (emotions, confidence in performance and evaluation of risk) of returning to sport after ACL reconstruction. Scores range from 0 to 100, and high scores were related to a positive psychological response	1 day before ACL reconstruction surgery
Primary	Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)	It is a specific 12-item questionnaire assessing the psychological impact (emotions, confidence in performance and evaluation of risk) of returning to sport after ACL reconstruction. Scores range from 0 to 100, and high scores were related to a positive psychological response	At 6 weeks after ACL reconstruction surgery.
Primary	Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)	It is a specific 12-item questionnaire assessing the psychological impact (emotions, confidence in performance and evaluation of risk) of returning to sport after ACL reconstruction. Scores range from 0 to 100, and high scores were related to a positive psychological response	At 12 weeks after ACL reconstruction surgery.
Primary	Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)	It is a specific 12-item questionnaire assessing the psychological impact (emotions, confidence in performance and evaluation of risk) of returning to sport after ACL reconstruction. Scores range from 0 to 100, and high scores were related to a positive psychological response	At 24 weeks after ACL reconstruction surgery.