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Status unknownNCT05461625Updated Jul 18, 2022

ACL Reconstruction With/Without ALL Reconstruction

An interventional study of ACL reconstruction and ALL anatomic in ACL Injury and ALL, sponsored by Centre of Postgraduate Medical Education. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-18.

Sponsored by Centre of Postgraduate Medical Education · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2021, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
762
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • ACL Injury
  • ALL

Keywords

  • ACL, ALL
03

In context

Anterior Cruciate Ligament Injuries

512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.

This study's planned enrollment of 762 is above the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Centre of Postgraduate Medical Education is the lead sponsor of 45 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • primary ACL injury

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
762 participants (estimated)

Study arms

  • Sham comparator
    ACL

    Anterior cruciate ligament reconstruction without additional procedure

    Procedure: ACL reconstruction

  • Active comparator
    ACL + ALL anatomic

    Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction

    Procedure: ACL reconstruction · Other: ALL anatomic

  • Active comparator
    ACL + ALL tenodesis

    Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis

    Procedure: ACL reconstruction · Other: ALL tenodesis

Interventions

  • ProcedureACL reconstruction

    Anterior cruciate ligament reconstruction

  • OtherALL anatomic

    anatomic anterolateral ligament reconstruction

  • OtherALL tenodesis

    anterolateral ligament teondesis

06

What researchers measure

Primary outcomes

  1. Knee stability

    KT-1000 assesment for knee stability

    Time frame: 24 months

Secondary outcomes

  1. Functional tests

    hop-for-distance

    Time frame: 12 months

  2. 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).

    Time frame: 6 weeks

  3. 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).

    Time frame: 6 months

  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).

    Time frame: 24 months

  5. 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).

    Time frame: 6 weeks

  6. 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).

    Time frame: 6 months

  7. 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).

    Time frame: 24 months

  8. 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.

    Time frame: 6 weeks

  9. 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.

    Time frame: 6 months

  10. 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.

    Time frame: 24 months

  11. SF-36 (36-Item Short Form Survey)

    Quality of life

    Time frame: 6 weeks

  12. SF-36 (36-Item Short Form Survey)

    Quality of life

    Time frame: 6 months

  13. SF-36 (36-Item Short Form Survey)

    Quality of life

    Time frame: 24 months

  14. 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).

    Time frame: 6 weeks

  15. 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).

    Time frame: 6 months

  16. 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).

    Time frame: 24 months

  17. 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

    Time frame: 6 weeks

  18. 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

    Time frame: 6 months

  19. 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

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital
    Otwock, Mazowieckie 05-400, Poland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05461625
Lead sponsor
Centre of Postgraduate Medical Education
Responsible party
Rafał Kamiński (Professor CMKP, Centre of Postgraduate Medical Education) — Principal investigator
First posted
Jul 18, 2022
Start date
Sep 1, 2021
Primary completion
Sep 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Jul 18, 2022

Study contacts

Rafal Kaminski
Contact
rkamiski@spskgruca.pl
+48227794031
Rafal Kaminski
study chair · SPSK CMKP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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