NCT04953676

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 27, 2021

Last Update Submit

June 27, 2021

Conditions

Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

  • KT-2000

    side-to-side difference

    6 months, 12 months, 24 months

Secondary Outcomes (5)

  • Tegner Score

    6 months, 12 months, 24 months

  • Lysholm Score

    6 months, 12 months, 24 months

  • IKDC Score

    6 months, 12 months, 24 months

  • Lachman test

    6 months, 12 months, 24 months

  • Pivot-shift test

    6 months, 12 months, 24 months

Study Arms (2)

Control Group

OTHER

round tunnel

Procedure: round tunnel technique

Experimental group

EXPERIMENTAL

flat tunnel

Procedure: flat tunnel technique

Interventions

round tunnel techniquePROCEDURE

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

Control Group
flat tunnel techniquePROCEDURE

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.

Experimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 8, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2024

Last Updated

July 8, 2021

Record last verified: 2021-06