ACL Reconstruction With/Without ALL Reconstruction
- Conditions
- ACL InjuryALL
- Interventions
- Procedure: ACL reconstructionOther: ALL tenodesisOther: ALL anatomic
- Registration Number
- NCT05461625
- Lead Sponsor
- Centre of Postgraduate Medical Education
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 762
- primary ACL injury
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACL ACL reconstruction Anterior cruciate ligament reconstruction without additional procedure ACL + ALL tenodesis ALL tenodesis Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis ACL + ALL anatomic ACL reconstruction Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction ACL + ALL anatomic ALL anatomic Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction ACL + ALL tenodesis ACL reconstruction Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis
- Primary Outcome Measures
Name Time Method Knee stability 24 months KT-1000 assesment for knee stability
- Secondary Outcome Measures
Name Time Method IKDC (International Knee Documentation Committee) subjective knee evaluation 24 months 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.
Functional tests 12 months hop-for-distance
VAS (Visual analog scale) 24 months 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 (Knee injury and Osteoarthritis Outcome Score) 24 months 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 24 months 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).
KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral) 24 months 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
SF-36 (36-Item Short Form Survey) 24 months Quality of life
Trial Locations
- Locations (1)
Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital
🇵🇱Otwock, Mazowieckie, Poland