A Clinical Trial of the Round-tunnel and Flat-tunnel Technique of ACL Reconstruction

NCT ID: NCT04953676

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-09-01

Brief Summary

This study intends to perform round-tunnel and flat-tunnel ACL reconstruction technique in 144 patients, and compare the clinical outcomes of the two surgical procedures through follow-up.

Detailed Description

This is a prospective randomized, controlled, multi-center clinical trial study on ACL reconstruction surgery technique. It is jointly undertaken by the Peking University Third Hospital, Nanjing Drum Tower Hospital, Zhengzhou Orthopaedic Hospital, and Shenzhen Second People's Hospital. Peking University Third Hospital is the team leader unit. In this study, 144 patients with ACL rupture were recruited according to the enrollment criteria. Among them, 54 patients with ACL rupture were recruited and carried out by the Peking University Third Hospital. The recruited patients were randomly divided into groups. The ratio of the control group is 1:1. Each of the other three hospitals recruited 30 patients and randomly grouped them according to the same enrollment criteria. The ratio of the experimental group to the control group was also 1:1. In this study, 72 patients with ACL rupture in the experimental group will be treated with flat-tunnel reconstruction technique, and 72 patients with ACL rupture in the control group will be treated with round-tunnel technique. All operations will be performed with autologous hamstring tendons. After reconstruction, all subjects will participate in the collection of clinical function scores including Tegner score, Lysholm score, IKDC score, and clinical evaluation including physical examination, joint laxity, CT and MRI imaging analysis to verify ACL Advantages of flat-tunnel technique.

Conditions

Anterior Cruciate Ligament Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

round tunnel

Group Type: OTHER

round tunnel technique

Intervention Type: PROCEDURE

Both the femoral tunnel and tibial tunnel were drilled by 8-mm cannulated drill

Experimental group

flat tunnel

Group Type: EXPERIMENTAL

flat tunnel technique

Intervention Type: PROCEDURE

Both the femoral tunnel and tibial tunnel were dimension of 5×11-mm rounded-rectangular, which was created by initially drilling a round tunnel with a 5-mm cannulated drill and reshaped by use of a bone rasp and custom-made dilator.

Interventions

round tunnel technique

Both the femoral tunnel and tibial tunnel were drilled by 8-mm cannulated drill

Intervention Type: PROCEDURE

flat tunnel technique

Both the femoral tunnel and tibial tunnel were dimension of 5×11-mm rounded-rectangular, which was created by initially drilling a round tunnel with a 5-mm cannulated drill and reshaped by use of a bone rasp and custom-made dilator.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• For the first time, the knee joint simply ruptures the anterior cruciate ligament (ACL) and requires surgical reconstruction; it can be combined with meniscus injury, and the Outerbridge injury score is ≤ Grade II; There is no history of trauma or fracture of the ipsilateral knee joint; Posterior Cruciate Ligament (PCL) has no damage; Medial Collateral Ligament (MCL) or Lateral collateral ligaments (LCL) has no damage or only slight damage (no more than I degree).

Exclusion Criteria

• BMI is less than 18.5 or greater than 35 kg/m2; Patients with moderate or severe knee degeneration; Those with limited flexion angle (<120 degrees); The cartilage defect area is greater than 2 cm2 or the Outerbridge damage score is> Grade II.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: collaborator

Zhengzhou Orthopaedic Hospital

UNKNOWN

Sponsor Role: collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

M2020149

Identifier Type: -

Identifier Source: org_study_id