ACL Reconstruction With/Without ALL Reconstruction

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

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.

Study Overview

• Status: Recruiting
• Conditions: ACL Injury; ALL
• Intervention / Treatment: Procedure: ACL reconstruction; Other: ALL anatomic; Other: ALL tenodesis

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 762
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafal Kaminski; Phone Number: +48227794031; Email: rkamiski@spskgruca.pl

Study Locations

• Poland
  • Mazowieckie
    • Otwock, Mazowieckie, Poland, 05-400
      • Recruiting
      • Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital
      • Contact: Rafal Kaminski, MD PhD; Phone Number: 469 +48227794031; Email: rkaminski@spskgruca.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: ACL; Anterior cruciate ligament reconstruction without additional procedure	Procedure: ACL reconstruction; Anterior cruciate ligament reconstruction
Active Comparator: ACL + ALL anatomic; Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction	Procedure: ACL reconstruction; Anterior cruciate ligament reconstruction; Other: ALL anatomic; anatomic anterolateral ligament reconstruction
Active Comparator: ACL + ALL tenodesis; Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis	Procedure: ACL reconstruction; Anterior cruciate ligament reconstruction; Other: ALL tenodesis; anterolateral ligament teondesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee stability	KT-1000 assesment for knee stability	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional tests	hop-for-distance	12 months
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
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
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
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
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
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
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
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
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
SF-36 (36-Item Short Form Survey)	Quality of life	6 weeks
SF-36 (36-Item Short Form Survey)	Quality of life	6 months
SF-36 (36-Item Short Form Survey)	Quality of life	24 months
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre of Postgraduate Medical Education
• Investigators: Study Chair: Rafal Kaminski, SPSK CMKP

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ACL, ALL
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: ACL_ALL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No