Back to resultsPrognosis Study of Different Anterior Cruciate Ligament Surgery Methods (ACLRSurgRCT)
Primary Purpose
Anterior Cruciate Ligament Injuries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anatomical single-bundle reconstruction（ASBR method）
Double-bundle reconstruction （DBR method）
Central axial single-bundle reconstruction（CASBR group）
rehabilitation training protocol
Educate patients on return to sports and the importance of quadriceps strength
Sponsored by
About this trial
This is an interventional prevention trial for Anterior Cruciate Ligament Injuries focused on measuring Anterior cruciate ligament (ACL), Signal of noise (SNQ), Graft bending angle (GBA), Central axial single-bundle, Anatomical single-bundle, Double bundle
Eligibility Criteria
Inclusion Criteria:
- Age from 18-45.
- ACL rupture confirmed by both physical examination and MRI.
- Surgery done by senior doctor.
- Using STG as autograft.
Exclusion Criteria:
- With bilateral acl rupture.
- Second injury.
- Previous surgery in extremity.
- With OA.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
ASBR group
CASBR group
DB group
Arm Description
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and ASBR procedures.
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and CASBR procedures.
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and DBR procedures.
Outcomes
Primary Outcome Measures
Magnetic resonance imaging (MRI) to assess graft healing
The difference in signal density between reconstructed ACL and PCL was used to measure graft ligamentation on MRI. Higher signal values represent higher inflammation and lower signal values represent better ligamentation.
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Knee laxity （physical exam）
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Knee laxity （KT-2000 arthrometer）
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Magnetic resonance imaging (MRI)
Magnetic resonance was used to calculate the graft bending angle (GBA), which is the angle between the intra-femoral graft and the intra-articular graft. GBA is associated with graft widening and graft healing.
Magnetic resonance imaging (MRI)
We used magnetic resonance 3D reconstruction to derive the area perpendicular to the bony canal and subdivide it into the proximal, mid and distal bony canal of the tibia and femur. Since CT is harmful to the human body, we used magnetic resonance imaging instead of CT to collect the last follow-up data of bone tract widening during the return visit.
Secondary Outcome Measures
Gender
Measuring whether gender is a risk factor for anterior cruciate ligament reconstruction failure
Age
Measuring whether age is a risk factor for anterior cruciate ligament reconstruction failure
BMI
Weight and height will be combined to report BMI in kg/m^2. Measuring whether bmi is a risk factor for anterior cruciate ligament reconstruction failure
Single-Legged Hop Test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Single-Legged Hop Test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Single-Legged Hop Test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Triple hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Triple hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Triple hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Cross hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Cross hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Cross hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
6-m hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
6-m hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
6-m hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Knee laxity
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Knee laxity
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Lysholm score
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Lysholm score
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Lysholm score
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Tegner Score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Tegner Score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Tegner Score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Short Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)
Patients will be asked to fill out the SF-36 to document the quality of life . General health-related quality of life: SF-36 physical component score (range 0 to 100; higher score = better health state) at 2 yearsTh minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Short Form (SF)-36 ,The medical outcome study 36-items short form health survey (SF-36)
Patients will be asked to fill out the SF-36 to document the quality of life.General health-related quality of life: SF-36 physical component score (range 0 to 100; higher score = better health state) at 5 years. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Short Form (SF)-36,The medical outcome study 36-items short form health survey
Patients will be asked to fill out the SF-36 to document the quality of life.General health-related quality of life: SF-36 physical component score (range 0 to 100; higher score = better health state) at 10 years. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Magnetic resonance imaging (MRI)
The difference in signal density between reconstructed ACL and PCL was used to measure graft ligamentation on MRI. Higher signal values represent higher inflammation and lower signal values represent better ligamentation.
Magnetic resonance imaging (MRI)
The difference in signal density between reconstructed ACL and PCL was used to measure graft ligamentation on MRI. Higher signal values represent higher inflammation and lower signal values represent better ligamentation.
Knee laxity （KT-2000 arthrometer）
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Knee laxity （KT-2000 arthrometer）
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Computed tomography (CT)
Computed tomography was used to acquire a baseline of the bone tunnel one days after ACL reconstruction for comparison in studies of bone tunnel widening at follow-up visits.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05400460
Brief Title
Prognosis Study of Different Anterior Cruciate Ligament Surgery Methods
Acronym
ACLRSurgRCT
Official Title
Outcomes Under Three Different Procedures for Anterior Cruciate Ligament Reconstruction, a Prospective Randomized Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
January 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yu Jiakuo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
406 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASBR group
Arm Type
Other
Arm Description
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and ASBR procedures.
Arm Title
CASBR group
Arm Type
Other
Arm Description
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and CASBR procedures.
Arm Title
DB group
Arm Type
Other
Arm Description
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and DBR procedures.
Intervention Type
Procedure
Intervention Name(s)
Anatomical single-bundle reconstruction（ASBR method）
Other Intervention Name(s)
ASB
Intervention Description
406 people were enrolled in the outpatient clinic, after screening for inclusion and exclusion. Of the remaining 243 patients who participated in this RCT, 81 were randomly assigned to the ASBR group to receive anatomic single-bundle reconstruction.We used hamstring as an autograft in the operation, and we chose the anatomical footprint of the anterior cruciate ligament for the positioning of the bone tunnel.Arthroscopic ASB ACL reconstruction was conducted with AMP technique.
Intervention Type
Procedure
Intervention Name(s)
Double-bundle reconstruction （DBR method）
Other Intervention Name(s)
DB
Intervention Description
406 people were enrolled in the outpatient clinic, after screening for inclusion and exclusion. Of the remaining 243 patients who participated in this RCT, 81 were randomly assigned to the DBR group to receive double bundle reconstruction.The hamstring autograft is still used for double-bundle reconstruction. The surgical approach is to treat the native ligaments as anteromedial bundles and posterolateral bundles and restore the structure of the two bundles of ligaments in the process of a
Intervention Type
Procedure
Intervention Name(s)
Central axial single-bundle reconstruction（CASBR group）
Other Intervention Name(s)
CASB
Intervention Description
406 people were enrolled in the outpatient clinic, after screening for inclusion and exclusion. Of the remaining 243 patients who participated in this RCT, 81 were randomly assigned to CASBR group.Arthroscopic ASB ACL reconstruction was conducted with transtibial technique and using Hamstring as autograft.Single-bundle reconstruction is used in CASBR reconstruction surgery.
The footprint of the implant on the lateral femoral condyle was chosen to be the location of the AMB bone canal in DB reconstruction surgery while the footprint of the implant on the tibial plateau was chosen to be the location of the bone canal of the PLB in DB reconstruction surgery.
Intervention Type
Other
Intervention Name(s)
rehabilitation training protocol
Intervention Description
The rehabilitation program for all patients followed a standardized Process. The first day after surgery, quadriceps sets, straight-leg raises, and prone hangs were initiated. All of the patients were allowed to walk with crutches and braces but with no weightbearing. The range of motion (ROM) progressed from 0 to 90 degrees 3 to 7 days postoperatively and reached 115 degrees within fourth week. Closed kinetic chain exercises and full weightbearing were started in the sixth week. Patients progressed to running without braces at 4 to 6 months.
Intervention Type
Other
Intervention Name(s)
Educate patients on return to sports and the importance of quadriceps strength
Intervention Description
Patients were interviewed by telephone preoperatively, 6 months postoperatively, and 1 year postoperatively to ask about Tegner scores and to encourage reasonable return to sports from 6 months postoperatively.
Inform patients of the possibility of osteoarthritis in patients undergoing ACL reconstruction preoperatively, 6 months postoperatively, and 1 year postoperatively in telephone interviews.Tell the patient that return to sports and quadriceps strength is a must if the knee cartilage damage is to improve.
Primary Outcome Measure Information:
Title
Magnetic resonance imaging (MRI) to assess graft healing
Description
The difference in signal density between reconstructed ACL and PCL was used to measure graft ligamentation on MRI. Higher signal values represent higher inflammation and lower signal values represent better ligamentation.
Time Frame
At 2 years after surgery
Title
Quadriceps strength
Description
Side to side quadriceps strength assessed by Biodex arthrometer test
Time Frame
At 2 years after surgery
Title
Knee laxity （physical exam）
Description
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Time Frame
At 2 years after surgery
Title
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Description
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 2 years after surgery
Title
Knee laxity （KT-2000 arthrometer）
Description
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Time Frame
At 2 years after surgery
Title
Magnetic resonance imaging (MRI)
Description
Magnetic resonance was used to calculate the graft bending angle (GBA), which is the angle between the intra-femoral graft and the intra-articular graft. GBA is associated with graft widening and graft healing.
Time Frame
At 2 years after surgery
Title
Magnetic resonance imaging (MRI)
Description
We used magnetic resonance 3D reconstruction to derive the area perpendicular to the bony canal and subdivide it into the proximal, mid and distal bony canal of the tibia and femur. Since CT is harmful to the human body, we used magnetic resonance imaging instead of CT to collect the last follow-up data of bone tract widening during the return visit.
Time Frame
At 2 years after surgery
Secondary Outcome Measure Information:
Title
Gender
Description
Measuring whether gender is a risk factor for anterior cruciate ligament reconstruction failure
Time Frame
At baseline
Title
Age
Description
Measuring whether age is a risk factor for anterior cruciate ligament reconstruction failure
Time Frame
At baseline
Title
BMI
Description
Weight and height will be combined to report BMI in kg/m^2. Measuring whether bmi is a risk factor for anterior cruciate ligament reconstruction failure
Time Frame
At baseline
Title
Single-Legged Hop Test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Time Frame
At 2 years after surgery
Title
Single-Legged Hop Test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Time Frame
At 5 years after surgery
Title
Single-Legged Hop Test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Time Frame
At 10 years after surgery
Title
Triple hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Time Frame
At 2 years after surgery
Title
Triple hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Time Frame
At 5 years after surgery
Title
Triple hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Time Frame
At 10 years after surgery
Title
Cross hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Time Frame
At 2 years after surgery
Title
Cross hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Time Frame
At 5 years after surgery
Title
Cross hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Time Frame
At 10 years after surgery
Title
6-m hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Time Frame
At 2 years after surgery
Title
6-m hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Time Frame
At 5 years after surgery
Title
6-m hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Time Frame
At 10 years after surgery
Title
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
Description
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Time Frame
At 2 years after surgery
Title
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
Description
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Time Frame
At 5 years after surgery
Title
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
Description
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Time Frame
At 10 years after surgery
Title
Knee laxity
Description
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Time Frame
At 5 years after surgery
Title
Knee laxity
Description
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Time Frame
At 10 years after surgery
Title
Quadriceps strength
Description
Side to side quadriceps strength assessed by Biodex arthrometer test
Time Frame
At 5 years after surgery
Title
Quadriceps strength
Description
Side to side quadriceps strength assessed by Biodex arthrometer test
Time Frame
At 10 years after surgery
Title
Lysholm score
Description
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 2 years after surgery
Title
Lysholm score
Description
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 5 years after surgery
Title
Lysholm score
Description
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 10 years after surgery
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 2 years after surgery
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 5 years after surgery
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 10 years after surgery
Title
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Description
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 5 years after surgery
Title
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Description
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 10 years after surgery
Title
Tegner Score
Description
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Time Frame
At 2 years after surgery
Title
Tegner Score
Description
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Time Frame
At 5 years after surgery
Title
Tegner Score
Description
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Time Frame
At 10 years after surgery
Title
Short Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)
Description
Patients will be asked to fill out the SF-36 to document the quality of life . General health-related quality of life: SF-36 physical component score (range 0 to 100; higher score = better health state) at 2 yearsTh minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 2 years after surgery
Title
Short Form (SF)-36 ,The medical outcome study 36-items short form health survey (SF-36)
Description
Patients will be asked to fill out the SF-36 to document the quality of life.General health-related quality of life: SF-36 physical component score (range 0 to 100; higher score = better health state) at 5 years. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 5 years after surgery
Title
Short Form (SF)-36,The medical outcome study 36-items short form health survey
Description
Patients will be asked to fill out the SF-36 to document the quality of life.General health-related quality of life: SF-36 physical component score (range 0 to 100; higher score = better health state) at 10 years. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 10 years after surgery
Title
Magnetic resonance imaging (MRI)
Description
The difference in signal density between reconstructed ACL and PCL was used to measure graft ligamentation on MRI. Higher signal values represent higher inflammation and lower signal values represent better ligamentation.
Time Frame
At 5 years after surgery
Title
Magnetic resonance imaging (MRI)
Description
The difference in signal density between reconstructed ACL and PCL was used to measure graft ligamentation on MRI. Higher signal values represent higher inflammation and lower signal values represent better ligamentation.
Time Frame
At 10 years after surgery
Title
Knee laxity （KT-2000 arthrometer）
Description
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Time Frame
At 5 years after surgery
Title
Knee laxity （KT-2000 arthrometer）
Description
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Time Frame
At 10 years after surgery
Title
Computed tomography (CT)
Description
Computed tomography was used to acquire a baseline of the bone tunnel one days after ACL reconstruction for comparison in studies of bone tunnel widening at follow-up visits.
Time Frame
At 1 days after surgery.(baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from 18-45.
ACL rupture confirmed by both physical examination and MRI.
Surgery done by senior doctor.
Using STG as autograft.
Exclusion Criteria:
With bilateral acl rupture.
Second injury.
Previous surgery in extremity.
With OA.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prognosis Study of Different Anterior Cruciate Ligament Surgery Methods
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