ACL Reconstruction With/Without ALL Reconstruction

ACL Injury Clinical Trial

Official title:

Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Anterior Cruciate Ligament Reconstruction With or Without Concomitant AnteroLateral Ligament Reconstruction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461625
• Other study ID #: ACL_ALL
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2022
• Source: Centre of Postgraduate Medical Education
• Contact: Rafal Kaminski
• Phone: +48227794031
• Email: rkamiski[@]spskgruca.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare Anterior Cruciate Reconstruction with or without Anterolateral Ligament Reconstruction in patients with ACL injury. The purpose of this study is evaluate if addition of ALLr to ACLr provides better clinical, radiological and laboratory outcomes.

Description:

This study compare ACL reconstruction and additional tenodesis or ALL recontruction described by Arnold. Patients will be randomized fot this tree group and surgeon will be blinded.

Anterolateral ligament reconstruction could play a role in augmenting rotational stability in the ACL-reconstructed knee and are most likely to benefit hyperlax patients, revision cases, pivoting athletes, and those with IKDC grade III pivot shifts. In our study we will would like to confirm this hypothesis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 762
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• primary ACL injury

Exclusion Criteria:

• no informed consent to participate in the study

• age under 18 years or above 65

• multilligament injury or single plane knee instability (medial, lateral)

• another musculoskeletal disorders in lower limb

• lower limb deformity requiring axis correction below 4o or above 12.5o

• joints inflammatory diseases

• ASA score > II

Related Conditions & MeSH terms

• ACL Injury
• ALL
• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• ACL reconstruction
Anterior cruciate ligament reconstruction

Other:
• ALL anatomic
anatomic anterolateral ligament reconstruction
• ALL tenodesis
anterolateral ligament teondesis

Locations

Country	Name	City	State
Poland	Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital	Otwock	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee stability	KT-1000 assesment for knee stability	24 months
Secondary	Functional tests	hop-for-distance	12 months
Secondary	KOOS (Knee injury and Osteoarthritis Outcome Score)	Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).	6 weeks
Secondary	KOOS (Knee injury and Osteoarthritis Outcome Score)	Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).	6 months
Secondary	KOOS (Knee injury and Osteoarthritis Outcome Score)	Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).	24 months
Secondary	Tegner Lysholm Knee Scoring Scale	The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).	6 weeks
Secondary	Tegner Lysholm Knee Scoring Scale	The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).	6 months
Secondary	Tegner Lysholm Knee Scoring Scale	The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).	24 months
Secondary	IKDC (International Knee Documentation Committee) subjective knee evaluation	IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. highr number representing higher levels of function.	6 weeks
Secondary	IKDC (International Knee Documentation Committee) subjective knee evaluation	IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. highr number representing higher levels of function.	6 months
Secondary	IKDC (International Knee Documentation Committee) subjective knee evaluation	IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. highr number representing higher levels of function.	24 months
Secondary	SF-36 (36-Item Short Form Survey)	Quality of life	6 weeks
Secondary	SF-36 (36-Item Short Form Survey)	Quality of life	6 months
Secondary	SF-36 (36-Item Short Form Survey)	Quality of life	24 months
Secondary	VAS (Visual analog scale)	The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).	6 weeks
Secondary	VAS (Visual analog scale)	Pain Visual Analog Scale; The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).	6 months
Secondary	VAS (Visual analog scale)	Pain Visual Analog Scale; The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).	24 months
Secondary	KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)	the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability	6 weeks
Secondary	KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)	the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability	6 months
Secondary	KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)	the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability	24 months