Anterior Cruciate Ligament InjuriesACLRSurgRCTNCT05400460
Prognosis Study of Different Anterior Cruciate Ligament Surgery Methods
A study testing Anatomical single-bundle reconstruction（ASBR method）, Double-bundle reconstruction （DBR method） and Central axial single-bundle reconstruction（CASBR group） in people with Anterior Cruciate Ligament Injuries, run by Yu Jiakuo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Anatomical single-bundle reconstruction（ASBR method）, Double-bundle reconstruction （DBR method） and Central axial single-bundle reconstruction（CASBR group）
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 17 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18-45.
- ACL rupture confirmed by both physical examination and MRI.
- Surgery done by senior doctor.
- Using STG as autograft.
Who cannot join
- With bilateral acl rupture.
- Second injury.
- Previous surgery in extremity.
- With OA.
About this study
Official title: Outcomes Under Three Different Procedures for Anterior Cruciate Ligament Reconstruction, a Prospective Randomized Cohort Study
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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- 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
- Keywords
- Anterior cruciate ligament (ACL), Signal of noise (SNQ), Graft bending angle (GBA), Central axial single-bundle, Anatomical single-bundle, Double bundle
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical single-bundle reconstruction（ASBR method）Procedure or surgery
Also called ASB
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.
Double-bundle reconstruction （DBR method）Procedure or surgery
Also called DB
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
Central axial single-bundle reconstruction（CASBR group）Procedure or surgery
Also called CASB
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.
rehabilitation training protocolOther
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.
Educate patients on return to sports and the importance of quadriceps strengthOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ASBR group | Other | Anterior cruciate ligament reconstruction using STG, absorbable interface nails and ASBR procedures. Receives: Procedure: Anatomical single-bundle reconstruction（ASBR method）; Other: rehabilitation training protocol; Other: Educate patients on return to sports and the importance of quadriceps strength |
| CASBR group | Other | Anterior cruciate ligament reconstruction using STG, absorbable interface nails and CASBR procedures. Receives: Procedure: Central axial single-bundle reconstruction（CASBR group）; Other: rehabilitation training protocol; Other: Educate patients on return to sports and the importance of quadriceps strength |
| DB group | Other | Anterior cruciate ligament reconstruction using STG, absorbable interface nails and DBR procedures. Receives: Procedure: Double-bundle reconstruction （DBR method）; Other: rehabilitation training protocol; Other: Educate patients on return to sports and the importance of quadriceps strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 2 years after surgery
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Measured: At 2 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 2 years after surgery
Secondary outcomes (41)
Gender
Measuring whether gender is a risk factor for anterior cruciate ligament reconstruction failure
Measured: At baseline
Age
Measuring whether age is a risk factor for anterior cruciate ligament reconstruction failure
Measured: At baseline
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
Measured: At baseline
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.
Measured: At 2 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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
Measured: At 2 years after surgery
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
Measured: At 5 years after surgery
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
Measured: At 10 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Measured: At 5 years after surgery
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Measured: At 10 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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.
Measured: At 2 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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.
Measured: At 5 years after surgery
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.
Measured: At 10 years after surgery
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.
Measured: At 1 days after surgery.(baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jun 2016
- Primary completion12 Feb 2020
- Study completion17 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu Jiakuo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Jiakuo, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400460
- Sponsor's protocol ID
- ACLSurgRCT-20160601
- Acronym
- ACLRSurgRCT
- Status last verified
- May 2022
- First submitted
- 1 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Xu Z, Song S, Mao Z, Huang X, Luo M, Zhou X, Xu B, Ye J, Song Y, Yu J. Which technique provides more benefits in return to sports and clinical outcomes after anterior cruciate ligament reconstruction: Double-bundle or single-bundle? A randomized controlled study. Chin Med J (Engl). 2025 Sep 20;138(18):2283-2292. doi: 10.1097/CM9.0000000000003267. Epub 2024 Oct 10.
PubMed 39385323
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Under Three Different Procedures for Anterior Cruciate Ligament Reconstruction, a Prospective Randomized Cohort Study
- ClinicalTrials.gov ID
- NCT05400460
- Acronym / sponsor ID
- ACLRSurgRCT / ACLSurgRCT-20160601
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Yu JiakuoUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 17 Jan 2021 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| ASBR group | Other | Procedure: Anatomical single-bundle reconstruction（ASBR method）, Other: rehabilitation training protocol, Other: Educate patients on return to sports and the importance of quadriceps strengthAnterior cruciate ligament reconstruction using STG, absorbable interface nails and ASBR procedures. |
| CASBR group | Other | Procedure: Central axial single-bundle reconstruction（CASBR group）, Other: rehabilitation training protocol, Other: Educate patients on return to sports and the importance of quadriceps strengthAnterior cruciate ligament reconstruction using STG, absorbable interface nails and CASBR procedures. |
| DB group | Other | Procedure: Double-bundle reconstruction （DBR method）, Other: rehabilitation training protocol, Other: Educate patients on return to sports and the importance of quadriceps strengthAnterior cruciate ligament reconstruction using STG, absorbable interface nails and DBR procedures. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 18-45.
- ACL rupture confirmed by both physical examination and MRI.
- Surgery done by senior doctor.
- Using STG as autograft.
Key exclusion criteria (4 listed)
- With bilateral acl rupture.
- Second injury.
- Previous surgery in extremity.
- With OA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomical single-bundle reconstruction（ASBR method）Also: ASB406 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. | Procedure or surgery | ASBR group |
| Double-bundle reconstruction （DBR method）Also: DB406 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 | Procedure or surgery | DB group |
| Central axial single-bundle reconstruction（CASBR group）Also: CASB406 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. | Procedure or surgery | CASBR group |
| rehabilitation training protocolThe 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. | Other | ASBR group, CASBR group, DB group |
| Educate patients on return to sports and the importance of quadriceps strengthPatients 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. | Other | ASBR group, CASBR group, DB group |
Primary outcome
Magnetic resonance imaging (MRI) to assess graft healing
Time frame: At 2 years after surgery
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
Time frame: At 2 years after surgery
Side to side quadriceps strength assessed by Biodex arthrometer test
Knee laxity （physical exam）
Time frame: At 2 years after surgery
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
Time frame: At 2 years after surgery
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）
Time frame: At 2 years after surgery
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)
Time frame: At 2 years after surgery
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)
Time frame: At 2 years after surgery
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.
41 secondary outcomes
Gender
Time frame: At baseline
Age
Time frame: At baseline
BMI
Time frame: At baseline
Single-Legged Hop Test
Time frame: At 2 years after surgery
Single-Legged Hop Test
Time frame: At 5 years after surgery
Single-Legged Hop Test
Time frame: At 10 years after surgery
Triple hop test
Time frame: At 2 years after surgery
Triple hop test
Time frame: At 5 years after surgery
Triple hop test
Time frame: At 10 years after surgery
Cross hop test
Time frame: At 2 years after surgery
Cross hop test
Time frame: At 5 years after surgery
Cross hop test
Time frame: At 10 years after surgery
6-m hop test
Time frame: At 2 years after surgery
6-m hop test
Time frame: At 5 years after surgery
6-m hop test
Time frame: At 10 years after surgery
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
Time frame: At 2 years after surgery
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
Time frame: At 5 years after surgery
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
Time frame: At 10 years after surgery
Knee laxity
Time frame: At 5 years after surgery
Knee laxity
Time frame: At 10 years after surgery
Quadriceps strength
Time frame: At 5 years after surgery
Quadriceps strength
Time frame: At 10 years after surgery
Lysholm score
Time frame: At 2 years after surgery
Lysholm score
Time frame: At 5 years after surgery
Lysholm score
Time frame: At 10 years after surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At 2 years after surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At 5 years after surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At 10 years after surgery
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Time frame: At 5 years after surgery
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Time frame: At 10 years after surgery
Tegner Score
Time frame: At 2 years after surgery
Tegner Score
Time frame: At 5 years after surgery
Tegner Score
Time frame: At 10 years after surgery
Short Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)
Time frame: At 2 years after surgery
Short Form (SF)-36 ,The medical outcome study 36-items short form health survey (SF-36)
Time frame: At 5 years after surgery
Short Form (SF)-36,The medical outcome study 36-items short form health survey
Time frame: At 10 years after surgery
Magnetic resonance imaging (MRI)
Time frame: At 5 years after surgery
Magnetic resonance imaging (MRI)
Time frame: At 10 years after surgery
Knee laxity （KT-2000 arthrometer）
Time frame: At 5 years after surgery
Knee laxity （KT-2000 arthrometer）
Time frame: At 10 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 39385323Wang X, Xu Z, Song S, Mao Z, Huang X, Luo M, Zhou X, Xu B, Ye J, Song Y, Yu J. Which technique provides more benefits in return to sports and clinical outcomes after anterior cruciate ligament reconstruction: Double-bundle or single-bundle? A randomized controlled study. Chin Med J (Engl). 2025 Sep 20;138(18):2283-2292. doi: 10.1097/CM9.0000000000003267. Epub 2024 Oct 10.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injuries
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomical single-bundle reconstruction（ASBR method）, Double-bundle reconstruction （DBR method） and Central axial single-bundle reconstruction（CASBR group） in people with Anterior Cruciate Ligament Injuries, run by Yu Jiakuo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic resonance imaging (MRI) to assess graft healing (time frame: At 2 years after surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05400460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.