Prognosis Study of Different Anterior Cruciate Ligament Surgery Methods

NCT05400460 | Completed DMC

• 1 other identifier: ACLSurgRCT-20160601
• Study Type: interventional
• Target: 406
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (7)

• 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.

  At 2 years after surgery

• Quadriceps strength

  Side to side quadriceps strength assessed by Biodex arthrometer test

  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.

  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.

  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.

  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.

  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.

  At 2 years after surgery

Secondary Outcomes (41)

• Gender

  At baseline

• Age

  At baseline

• BMI

  At baseline

• Single-Legged Hop Test

  At 2 years after surgery

• Single-Legged Hop Test

  At 5 years after surgery

Study Arms (3)

ASBR group

OTHER

Anterior cruciate ligament reconstruction using STG, absorbable interface nails and ASBR procedures.

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.

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.

Procedure: Double-bundle reconstruction （DBR method）; Other: rehabilitation training protocol; Other: Educate patients on return to sports and the importance of quadriceps strength

Interventions

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.

Also known as: ASB

ASBR group

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

Also known as: DB

DB group

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.

Also known as: CASB

CASBR group

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.

ASBR group; CASBR group; DB group

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.

ASBR group; CASBR group; DB group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• With bilateral acl rupture.
• Second injury.
• Previous surgery in extremity.
• With OA.

Sponsors & Collaborators

• Yu Jiakuo: lead

Related Publications (1)

• 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.

  PMID: 39385323 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: June 1, 2022
• Study Start: June 1, 2016
• Primary Completion: February 12, 2020
• Study Completion: January 17, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share