NCT04366362

Brief Summary

A randomised prospective control trial comparing the efficiency of a more individualized approach in ACL reconstruction with the help of neuromuscular computer models with traditional ACL reconstruction practices.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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 10, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

3.1 years

First QC Date

June 10, 2019

Last Update Submit

November 16, 2021

Conditions

Anterior Cruciate Ligament Injuries

Keywords

ACLAnteriorCruciateLigamentReconstructionIndividualisedAnatomicalNavigation

Outcome Measures

Primary Outcomes (1)

  • Comparison of the change of stability of the operated knee between the two groups from Baseline until 1 year post-operation

    Participants in two groups will be assessed with KT2000 arthrometer before and after ACL reconstruction regarding knee stability. Additionally knee kinematics and gait analysis before and after the ACL reconstruction will be compared between the two groups in a gait analysis lab.

    Baseline and 1 year post operation

Secondary Outcomes (4)

  • Compare the change from Baseline between the patients of the two groups in KOOS (Knee Injury & Osteoarthritis Outcome) from the baseline until 1 year post operation

    Baseline and 1 year post operation

  • Compare the change from Baseline between the patients of the two groups in IKDC (International Knee Documentation Committee Subjective Knee Form) from the baseline until 1 year post operation.

    Baseline and 1 year post operation

  • Compare the change from Baseline between the patients of the two groups in Tegner Lysholm Knee Scoring Scale from the baseline until 1 year post operation.

    Baseline and 1 year post operation

  • Compare the post operation MRI of the 2 groups

    1 year post operation

Study Arms (2)

Convetional reconstruction group

ACTIVE COMPARATOR

Patients will undergo ACL reconstruction based on conventional ACL surgery

Procedure: Conventional ACL reconstruction

Individualised reconstruction group

EXPERIMENTAL

Patients will undergo ACL reconstruction based on their special anatomical and functional characteristics and with the use of a navigation system

Procedure: Individualised ACL reconstruction

Interventions

Individualised ACL reconstructionPROCEDURE

ACL reconstruction based on anatomical and functional distinctiveness of each patient separately

Individualised reconstruction group
Conventional ACL reconstructionPROCEDURE

ACL reconstruction based on surgeons experience without taking into account any other patients characteristics

Convetional reconstruction group

Eligibility Criteria

Age14 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with ACL rupture undergoing ACL reconstruction surgery with closed epiphyses, younger than 45 years old

You may not qualify if:

  • No previous surgery in the knee (except partial meniscectomy), no major systematic pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael Hantes

Larissa, Greece

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Michael Hantes, MD

    University General Hospital of Larissa

    STUDY CHAIR

Central Study Contacts

Georgios Chalatsis, MD

CONTACT

00306977992086ghalatsis@hotmail.com

michael hantes, MD

CONTACT

hantesmi@otenet.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will not be aware of the group that they will be part of. Assessors before and after surgery will not be aware of patients groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups of patients, randomly assigned
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, PhD Cand, Resident in Orthopaedics

Study Record Dates

First Submitted

June 10, 2019

First Posted

April 28, 2020

Study Start

March 2, 2020

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations

GR(1)