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ACL Reconstruction With/Without ALL Reconstruction

Primary Purpose

ACL Injury, ALL

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
ACL reconstruction
ALL anatomic
ALL tenodesis
Sponsored by
Centre of Postgraduate Medical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury focused on measuring ACL, ALL

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

ACL

ACL + ALL anatomic

ACL + ALL tenodesis

Arm Description

Anterior cruciate ligament reconstruction without additional procedure

Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction

Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis

Outcomes

Primary Outcome Measures

Knee stability
KT-1000 assesment for knee stability

Secondary Outcome Measures

Functional tests
hop-for-distance
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).
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).
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).
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).
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).
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).
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.
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.
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.
SF-36 (36-Item Short Form Survey)
Quality of life
SF-36 (36-Item Short Form Survey)
Quality of life
SF-36 (36-Item Short Form Survey)
Quality of life
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).
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).
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).
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
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
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

Full Information

First Posted
February 3, 2022
Last Updated
July 13, 2022
Sponsor
Centre of Postgraduate Medical Education
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1. Study Identification

Unique Protocol Identification Number
NCT05461625
Brief Title
ACL Reconstruction With/Without ALL Reconstruction
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre of Postgraduate Medical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, ALL
Keywords
ACL, ALL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
762 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACL
Arm Type
Sham Comparator
Arm Description
Anterior cruciate ligament reconstruction without additional procedure
Arm Title
ACL + ALL anatomic
Arm Type
Active Comparator
Arm Description
Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction
Arm Title
ACL + ALL tenodesis
Arm Type
Active Comparator
Arm Description
Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis
Intervention Type
Procedure
Intervention Name(s)
ACL reconstruction
Intervention Description
Anterior cruciate ligament reconstruction
Intervention Type
Other
Intervention Name(s)
ALL anatomic
Intervention Description
anatomic anterolateral ligament reconstruction
Intervention Type
Other
Intervention Name(s)
ALL tenodesis
Intervention Description
anterolateral ligament teondesis
Primary Outcome Measure Information:
Title
Knee stability
Description
KT-1000 assesment for knee stability
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Functional tests
Description
hop-for-distance
Time Frame
12 months
Title
KOOS (Knee injury and Osteoarthritis Outcome Score)
Description
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).
Time Frame
6 weeks
Title
KOOS (Knee injury and Osteoarthritis Outcome Score)
Description
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).
Time Frame
6 months
Title
KOOS (Knee injury and Osteoarthritis Outcome Score)
Description
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).
Time Frame
24 months
Title
Tegner Lysholm Knee Scoring Scale
Description
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).
Time Frame
6 weeks
Title
Tegner Lysholm Knee Scoring Scale
Description
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).
Time Frame
6 months
Title
Tegner Lysholm Knee Scoring Scale
Description
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).
Time Frame
24 months
Title
IKDC (International Knee Documentation Committee) subjective knee evaluation
Description
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.
Time Frame
6 weeks
Title
IKDC (International Knee Documentation Committee) subjective knee evaluation
Description
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.
Time Frame
6 months
Title
IKDC (International Knee Documentation Committee) subjective knee evaluation
Description
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.
Time Frame
24 months
Title
SF-36 (36-Item Short Form Survey)
Description
Quality of life
Time Frame
6 weeks
Title
SF-36 (36-Item Short Form Survey)
Description
Quality of life
Time Frame
6 months
Title
SF-36 (36-Item Short Form Survey)
Description
Quality of life
Time Frame
24 months
Title
VAS (Visual analog scale)
Description
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).
Time Frame
6 weeks
Title
VAS (Visual analog scale)
Description
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).
Time Frame
6 months
Title
VAS (Visual analog scale)
Description
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).
Time Frame
24 months
Title
KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)
Description
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
Time Frame
6 weeks
Title
KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)
Description
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
Time Frame
6 months
Title
KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)
Description
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
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafal Kaminski
Phone
+48227794031
Email
rkamiski@spskgruca.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafal Kaminski
Organizational Affiliation
SPSK CMKP
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafal Kaminski, MD PhD
Phone
+48227794031
Ext
469
Email
rkaminski@spskgruca.pl
First Name & Middle Initial & Last Name & Degree
Stanislaw Pomianowski, MD PhD Prof
Phone
+48227794031
Ext
481
Email
spom@spskgruca.pl

12. IPD Sharing Statement

Learn more about this trial

ACL Reconstruction With/Without ALL Reconstruction

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