ACL InjuryNCT05461625
ACL Reconstruction With/Without ALL Reconstruction
A study testing ACL reconstruction, ALL anatomic and ALL tenodesis in people with ACL Injury and ALL, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury, ALL
- What is being tested?
- ACL reconstruction, ALL anatomic and ALL tenodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 762 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- primary ACL injury
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital
Otwock, Masovian Voivodeship, 05-400
Rafal Kaminski, MD PhD, +48227794031 ext. 469, rkaminski@spskgruca.pl
Stanislaw Pomianowski, MD PhD Prof, +48227794031 ext. 481, spom@spskgruca.pl
About this study
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.
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.
Read the 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.
- Conditions
- ACL Injury, ALL
- Being tested
- ACL reconstruction, ALL anatomic, ALL tenodesis
- Keywords
- ACL, ALL
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstructionProcedure or surgery
Anterior cruciate ligament reconstruction
ALL anatomicOther
anatomic anterolateral ligament reconstruction
ALL tenodesisOther
anterolateral ligament teondesis
| Study group | Role | What they receive |
|---|---|---|
| ACL | Sham comparator | Anterior cruciate ligament reconstruction without additional procedure Receives: Procedure: ACL reconstruction |
| ACL + ALL anatomic | Active comparator | Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction Receives: Procedure: ACL reconstruction; Other: ALL anatomic |
| ACL + ALL tenodesis | Active comparator | Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis Receives: Procedure: ACL reconstruction; Other: ALL tenodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee stability
KT-1000 assesment for knee stability
Measured: 24 months
Secondary outcomes (19)
Functional tests
hop-for-distance
Measured: 12 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).
Measured: 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).
Measured: 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).
Measured: 24 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
SF-36 (36-Item Short Form Survey)
Quality of life
Measured: 6 weeks
SF-36 (36-Item Short Form Survey)
Quality of life
Measured: 6 months
SF-36 (36-Item Short Form Survey)
Quality of life
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Sep 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 762 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafał Kamiński, Centre of Postgraduate Medical Education
- Investigators
- Rafal Kaminski, Study chair, SPSK CMKP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461625
- Sponsor's protocol ID
- ACL_ALL
- Status last verified
- Jul 2022
- First submitted
- 3 Feb 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05461625
- Acronym / sponsor ID
- ACL_ALL
- Conditions
- ACL Injury, ALL
- Keywords
- ACL, ALL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 762 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACL | Sham comparator | Procedure: ACL reconstructionAnterior cruciate ligament reconstruction without additional procedure |
| ACL + ALL anatomic | Active comparator | Procedure: ACL reconstruction, Other: ALL anatomicAnterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction |
| ACL + ALL tenodesis | Active comparator | Procedure: ACL reconstruction, Other: ALL tenodesisAnterior cruciate ligament reconstruction and anterolateral ligament tenodesis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary ACL injury
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL reconstructionAnterior cruciate ligament reconstruction | Procedure or surgery | ACL, ACL + ALL anatomic, ACL + ALL tenodesis |
| ALL anatomicanatomic anterolateral ligament reconstruction | Other | ACL + ALL anatomic |
| ALL tenodesisanterolateral ligament teondesis | Other | ACL + ALL tenodesis |
Primary outcome
Knee stability
Time frame: 24 months
KT-1000 assesment for knee stability
19 secondary outcomes
Functional tests
Time frame: 12 months
KOOS (Knee injury and Osteoarthritis Outcome Score)
Time frame: 6 weeks
KOOS (Knee injury and Osteoarthritis Outcome Score)
Time frame: 6 months
KOOS (Knee injury and Osteoarthritis Outcome Score)
Time frame: 24 months
Tegner Lysholm Knee Scoring Scale
Time frame: 6 weeks
Tegner Lysholm Knee Scoring Scale
Time frame: 6 months
Tegner Lysholm Knee Scoring Scale
Time frame: 24 months
IKDC (International Knee Documentation Committee) subjective knee evaluation
Time frame: 6 weeks
IKDC (International Knee Documentation Committee) subjective knee evaluation
Time frame: 6 months
IKDC (International Knee Documentation Committee) subjective knee evaluation
Time frame: 24 months
SF-36 (36-Item Short Form Survey)
Time frame: 6 weeks
SF-36 (36-Item Short Form Survey)
Time frame: 6 months
SF-36 (36-Item Short Form Survey)
Time frame: 24 months
VAS (Visual analog scale)
Time frame: 6 weeks
VAS (Visual analog scale)
Time frame: 6 months
VAS (Visual analog scale)
Time frame: 24 months
KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)
Time frame: 6 weeks
KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)
Time frame: 6 months
KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafal Kaminski study chair
SPSK CMKP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction, ALL anatomic and ALL tenodesis in people with ACL Injury and ALL, run by Centre of Postgraduate Medical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafal Kaminski (+48227794031, rkamiski@spskgruca.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee stability (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.