Prognosis Study of Different Anterior Cruciate Ligament Surgery Methods (ACLRSurgRCT)

Yu Jiakuo

Status: Completed

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Procedure: Double-bundle reconstruction （DBR method）; Procedure: Central axial single-bundle reconstruction（CASBR group）; Procedure: Anatomical single-bundle reconstruction（ASBR method）; Other: rehabilitation training protocol; Other: Educate patients on return to sports and the importance of quadriceps strength

Study type: Interventional

Funder types: Other

Identifiers

NCT05400460

ACLSurgRCT-20160601

Details and patient eligibility

About

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.

Enrollment: 406 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. With bilateral acl rupture.
2. Second injury.
3. Previous surgery in extremity.
4. With OA.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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406 participants in 3 patient groups

ASBR group

Other group

Description:

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

Treatment:

Other: rehabilitation training protocol

Other: Educate patients on return to sports and the importance of quadriceps strength

Procedure: Anatomical single-bundle reconstruction（ASBR method）

CASBR group

Other group

Description:

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

Treatment:

Other: rehabilitation training protocol

Other: Educate patients on return to sports and the importance of quadriceps strength

Procedure: Central axial single-bundle reconstruction（CASBR group）

DB group

Other group

Description:

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

Treatment:

Other: rehabilitation training protocol

Other: Educate patients on return to sports and the importance of quadriceps strength

Procedure: Double-bundle reconstruction （DBR method）