NCT05574946

Brief Summary

This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 80 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

October 28, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

October 6, 2022

Last Update Submit

December 20, 2024

Conditions

Anterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (1)

  • Signal to Noise Quotient

    Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation

    1 year

Secondary Outcomes (4)

  • Difference in Computed Tomography (CT) imaging of Tunnels

    1 day, 6 months, 1 year

  • International Knee Documentation Committee (IKDC)

    1 year

  • Marx Activity Rating Score

    1 year

  • Side to side difference in anterior tibial translation

    6 weeks, 3 months, 6 months, 9 months, 1 year

Study Arms (2)

All-inside technique

EXPERIMENTAL

Both of the femoral and tibial tunnel will be drilled in a retrograde manner using flip-cutter and femoral and tibial sockets will be created. Graft will be passed from the portal. Adjustable suspensory cortical fixation both on tibial and femoral side will be used.

Procedure: Anterior Cruciate Ligament Reconstruction

Complete tibial tunnel technique

ACTIVE COMPARATOR

Femoral tunnel will be drilled in an inside-outside manner using standard technique. Then the tibial tunnel will be drilled completely. Graft will be passed from the tibial tunnel. Adjustable suspensory cortical fixation both on the tibial and femoral side will be used.

Procedure: Anterior Cruciate Ligament Reconstruction

Interventions

Anterior Cruciate Ligament ReconstructionPROCEDURE

Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft

All-inside techniqueComplete tibial tunnel technique

Eligibility Criteria

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

You may qualify if:

  • Patients who have provided informed written written consent;
  • Patients aged between 18 and 45;
  • Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)
  • Patients undergoing ACL reconstruction with a 8 mm four-strand semitendinosus autograft

You may not qualify if:

  • Patients who have not signed informed consent;
  • Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
  • Revision procedures
  • Patients unable to lay still in an MRI or CT scanner
  • Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.
  • Patients who had an excessive tibial slope \>12 degrees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsun University

Samsun, Samsun, Turkey (Türkiye)

Location

Ahmet E. Okutan

Samsun, Turkey (Türkiye)

Location

Related Publications (2)

  • Bhimani R, Shahriarirad R, Ranjbar K, Erfani A, Ashkani-Esfahani S. Transportal versus all-inside techniques of anterior cruciate ligament reconstruction: a systematic review. J Orthop Surg Res. 2021 Dec 23;16(1):734. doi: 10.1186/s13018-021-02872-x.

    PMID: 34949188BACKGROUND

  • Colombet P, Saffarini M, Bouguennec N. Clinical and Functional Outcomes of Anterior Cruciate Ligament Reconstruction at a Minimum of 2 Years Using Adjustable Suspensory Fixation in Both the Femur and Tibia: A Prospective Study. Orthop J Sports Med. 2018 Oct 22;6(10):2325967118804128. doi: 10.1177/2325967118804128. eCollection 2018 Oct.

    PMID: 30364847BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 12, 2022

Study Start

October 28, 2022

Primary Completion

July 1, 2024

Study Completion

November 20, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)