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Completed

NCT Number: NCT05400460

Prognosis Study of Different Anterior Cruciate Ligament Surgery Methods

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anatomical single-bundle reconstruction（ASBR method）

Procedure

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.

Other names: ASB

Double-bundle reconstruction （DBR method）

Procedure

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

Other names: DB

Central axial single-bundle reconstruction（CASBR group）

Procedure

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.

Other names: CASB

Rehabilitation Training Protocol

Other

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

Other

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 outcomes

  1. 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.

  2. Quadriceps strength

    Time frame: At 2 years after surgery

    Side to side quadriceps strength assessed by Biodex arthrometer test

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Gender

    Time frame: At baseline

    Measuring whether gender is a risk factor for anterior cruciate ligament reconstruction failure

  2. Age

    Time frame: At baseline

    Measuring whether age is a risk factor for anterior cruciate ligament reconstruction failure

  3. BMI

    Time frame: At baseline

    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

  4. Single-Legged Hop Test

    Time frame: At 2 years after surgery

    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.

  5. Single-Legged Hop Test

    Time frame: At 5 years after surgery

    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.

  6. Single-Legged Hop Test

    Time frame: At 10 years after surgery

    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.

  7. Triple hop test

    Time frame: At 2 years after surgery

    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.

  8. Triple hop test

    Time frame: At 5 years after surgery

    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.

  9. Triple hop test

    Time frame: At 10 years after surgery

    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.

  10. Cross hop test

    Time frame: At 2 years after surgery

    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.

  11. Cross hop test

    Time frame: At 5 years after surgery

    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.

  12. Cross hop test

    Time frame: At 10 years after surgery

    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.

  13. 6-m hop test

    Time frame: At 2 years after surgery

    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.

  14. 6-m hop test

    Time frame: At 5 years after surgery

    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.

  15. 6-m hop test

    Time frame: At 10 years after surgery

    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.

  16. Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale

    Time frame: At 2 years after surgery

    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

  17. Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale

    Time frame: At 5 years after surgery

    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

  18. Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale

    Time frame: At 10 years after surgery

    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

  19. Knee laxity

    Time frame: At 5 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.

  20. Knee laxity

    Time frame: At 10 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.

  21. Quadriceps strength

    Time frame: At 5 years after surgery

    Side to side quadriceps strength assessed by Biodex arthrometer test

  22. Quadriceps strength

    Time frame: At 10 years after surgery

    Side to side quadriceps strength assessed by Biodex arthrometer test

  23. Lysholm score

    Time frame: At 2 years after surgery

    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.

  24. Lysholm score

    Time frame: At 5 years after surgery

    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.

  25. Lysholm score

    Time frame: At 10 years after surgery

    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.

  26. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: At 2 years after surgery

    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.

  27. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: At 5 years after surgery

    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.

  28. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: At 10 years after surgery

    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.

  29. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000

    Time frame: At 5 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.

  30. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000

    Time frame: At 10 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.

  31. Tegner Score

    Time frame: At 2 years after surgery

    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.

  32. Tegner Score

    Time frame: At 5 years after surgery

    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.

  33. Tegner Score

    Time frame: At 10 years after surgery

    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.

  34. Short Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)

    Time frame: At 2 years after surgery

    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.

  35. Short Form (SF)-36 ,The medical outcome study 36-items short form health survey (SF-36)

    Time frame: At 5 years after surgery

    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.

  36. Short Form (SF)-36,The medical outcome study 36-items short form health survey

    Time frame: At 10 years after surgery

    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.

  37. Magnetic resonance imaging (MRI)

    Time frame: At 5 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.

  38. Magnetic resonance imaging (MRI)

    Time frame: At 10 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.

  39. Knee laxity （KT-2000 arthrometer）

    Time frame: At 5 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.

  40. Knee laxity （KT-2000 arthrometer）

    Time frame: At 10 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.

  41. Computed tomography (CT)

    Time frame: At 1 days after surgery.(baseline)

    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.

Sponsors and collaborators

Lead sponsor

Yu Jiakuo

Other

Registry information

Official study title

Outcomes Under Three Different Procedures for Anterior Cruciate Ligament Reconstruction, a Prospective Randomized Cohort Study

Acronym: ACLRSurgRCT

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jun 1, 2022
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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