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

A Randomized, Controlled, Multi-center Clinical Trial of the Round-tunnel and Flat-tunnel Technique of Anterior Cruciate Ligament (ACL) Reconstruction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Procedure: round tunnel technique; Procedure: flat tunnel technique

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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Control Group; round tunnel	Procedure: round tunnel technique; Both the femoral tunnel and tibial tunnel were drilled by 8-mm cannulated drill
EXPERIMENTAL: Experimental group; flat tunnel	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KT-2000	side-to-side difference	6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tegner Score	functional scores	6 months, 12 months, 24 months
Lysholm Score	functional scores	6 months, 12 months, 24 months
IKDC Score	functional scores	6 months, 12 months, 24 months
Lachman test	physical examination	6 months, 12 months, 24 months
Pivot-shift test	physical examination	6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Shenzhen Second People's Hospital; Zhengzhou Orthopaedic Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (ACTUAL): July 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: M2020149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No