Clinical trial NCT05461625: 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
Overall status: UNKNOWN
Phase: NA
Conditions: ACL Injury
ALL
Keywords: ACL, ALL
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 762
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Knee stability
timeFrame: 24 months
Secondary outcomes:
measure: Functional tests
timeFrame: 12 months
measure: KOOS (Knee injury and Osteoarthritis Outcome Score)
timeFrame: 6 weeks
measure: KOOS (Knee injury and Osteoarthritis Outcome Score)
timeFrame: 6 months
measure: KOOS (Knee injury and Osteoarthritis Outcome Score)
timeFrame: 24 months
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 6 weeks
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 6 months
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 24 months
measure: IKDC (International Knee Documentation Committee) subjective knee evaluation
timeFrame: 6 weeks
measure: IKDC (International Knee Documentation Committee) subjective knee evaluation
timeFrame: 6 months
measure: IKDC (International Knee Documentation Committee) subjective knee evaluation
timeFrame: 24 months
measure: SF-36 (36-Item Short Form Survey)
timeFrame: 6 weeks
measure: SF-36 (36-Item Short Form Survey)
timeFrame: 6 months
measure: SF-36 (36-Item Short Form Survey)
timeFrame: 24 months
measure: VAS (Visual analog scale)
timeFrame: 6 weeks
measure: VAS (Visual analog scale)
timeFrame: 6 months
measure: VAS (Visual analog scale)
timeFrame: 24 months
measure: KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)
timeFrame: 6 weeks
measure: KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)
timeFrame: 6 months
measure: KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)
timeFrame: 24 months
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital
state: Mazowieckie
Study officials:
affiliation: SPSK CMKP
name: Rafal Kaminski
role: STUDY_CHAIR
References: