Prognosis Study of Different Anterior Cruciate Ligament Surgery Methods
NCT ID: NCT05400460
Last Updated: 2022-06-01
Study Results
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Basic Information
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COMPLETED
NA
406 participants
INTERVENTIONAL
2016-06-01
2021-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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ASBR group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and ASBR procedures.
Anatomical single-bundle reconstruction（ASBR method）
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.
rehabilitation training protocol
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 strength
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.
CASBR group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and CASBR procedures.
Central axial single-bundle reconstruction（CASBR group）
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 protocol
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 strength
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.
DB group
Anterior cruciate ligament reconstruction using STG, absorbable interface nails and DBR procedures.
Double-bundle reconstruction （DBR method）
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
rehabilitation training protocol
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 strength
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.
Interventions
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Anatomical single-bundle reconstruction（ASBR method）
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）
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）
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 protocol
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 strength
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ACL rupture confirmed by both physical examination and MRI.
3. Surgery done by senior doctor.
4. Using STG as autograft.
Exclusion Criteria
2. Second injury.
3. Previous surgery in extremity.
4. With OA.
18 Years
45 Years
ALL
No
Sponsors
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Yu Jiakuo
OTHER
Responsible Party
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Yu Jiakuo
Clinical Professor
References
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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.
Other Identifiers
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ACLSurgRCT-20160601
Identifier Type: -
Identifier Source: org_study_id
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