Clinical trial NCT05400460: Prognosis Study of Different Anterior Cruciate Ligament Surgery Methods
Official title: Outcomes Under Three Different Procedures for Anterior Cruciate Ligament Reconstruction, a Prospective Randomized Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: Anterior cruciate ligament (ACL)
Signal of noise (SNQ)
Graft bending angle (GBA)
Central axial single-bundle
Anatomical single-bundle
Double bundle
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized cohort of patients with anterior cruciate ligament rupture assigned to three procedures and followed up two years after surgery.In this trial, patients diagnosed with anterior cruciate ligament rupture in the outpatient clinic were randomly assigned to the following three procedures: central axial single-bundle reconstruction (CASBR), anatomical single-bundle reconstruction (ASBR), and double-bundle reconstruction (DBR).
Primary purpose: PREVENTION

Brief summary: From June 1, 2016, to July 1, 2017, a total of 406 patients with ACL rupture were randomly assigned to three different ACL surgeries: anatomical single-bundle, central axial single-bundle and double-bundle. A prospective randomized cohort study was conducted.


Eligibility criteria: Inclusion Criteria:

1. Age from 18-45.
2. ACL rupture confirmed by both physical examination and MRI.
3. Surgery done by senior doctor.
4. Using STG as autograft.

Exclusion Criteria:

1. With bilateral acl rupture.
2. Second injury.
3. Previous surgery in extremity.
4. With OA.

Primary outcomes:
measure: Magnetic resonance imaging (MRI) to assess graft healing
timeFrame: At 2 years after surgery
measure: Quadriceps strength
timeFrame: At 2 years after surgery
measure: Knee laxity （physical exam）
timeFrame: At 2 years after surgery
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
timeFrame: At 2 years after surgery
measure: Knee laxity （KT-2000 arthrometer）
timeFrame: At 2 years after surgery
measure: Magnetic resonance imaging (MRI)
timeFrame: At 2 years after surgery
measure: Magnetic resonance imaging (MRI)
timeFrame: At 2 years after surgery
Secondary outcomes:
measure: Gender
timeFrame: At baseline
measure: Age
timeFrame: At baseline
measure: BMI
timeFrame: At baseline
measure: Single-Legged Hop Test
timeFrame: At 2 years after surgery
measure: Single-Legged Hop Test
timeFrame: At 5 years after surgery
measure: Single-Legged Hop Test
timeFrame: At 10 years after surgery
measure: Triple hop test
timeFrame: At 2 years after surgery
measure: Triple hop test
timeFrame: At 5 years after surgery
measure: Triple hop test
timeFrame: At 10 years after surgery
measure: Cross hop test
timeFrame: At 2 years after surgery
measure: Cross hop test
timeFrame: At 5 years after surgery
measure: Cross hop test
timeFrame: At 10 years after surgery
measure: 6-m hop test
timeFrame: At 2 years after surgery
measure: 6-m hop test
timeFrame: At 5 years after surgery
measure: 6-m hop test
timeFrame: At 10 years after surgery
measure: Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
timeFrame: At 2 years after surgery
measure: Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
timeFrame: At 5 years after surgery
measure: Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
timeFrame: At 10 years after surgery
measure: Knee laxity
timeFrame: At 5 years after surgery
measure: Knee laxity
timeFrame: At 10 years after surgery
measure: Quadriceps strength
timeFrame: At 5 years after surgery
measure: Quadriceps strength
timeFrame: At 10 years after surgery
measure: Lysholm score
timeFrame: At 2 years after surgery
measure: Lysholm score
timeFrame: At 5 years after surgery
measure: Lysholm score
timeFrame: At 10 years after surgery
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At 2 years after surgery
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At 5 years after surgery
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At 10 years after surgery
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
timeFrame: At 5 years after surgery
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
timeFrame: At 10 years after surgery
measure: Tegner Score
timeFrame: At 2 years after surgery
measure: Tegner Score
timeFrame: At 5 years after surgery
measure: Tegner Score
timeFrame: At 10 years after surgery
measure: Short Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)
timeFrame: At 2 years after surgery
measure: Short Form (SF)-36 ,The medical outcome study 36-items short form health survey (SF-36)
timeFrame: At 5 years after surgery
measure: Short Form (SF)-36,The medical outcome study 36-items short form health survey
timeFrame: At 10 years after surgery
measure: Magnetic resonance imaging (MRI)
timeFrame: At 5 years after surgery
measure: Magnetic resonance imaging (MRI)
timeFrame: At 10 years after surgery
measure: Knee laxity （KT-2000 arthrometer）
timeFrame: At 5 years after surgery
measure: Knee laxity （KT-2000 arthrometer）
timeFrame: At 10 years after surgery
measure: Computed tomography (CT)
timeFrame: At 1 days after surgery.(baseline)
Other outcomes:
Locations:
Study officials:
References: