MedDataX Logo

Individualized Anterior Cruciate Ligament Versus Conventional Reconstruction

NCT ID: NCT04366362

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-02

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Until now the ACL reconstruction was based on the surgeon's experience. An individualised ACL reconstruction is customized based on each patient's special characteristics. Preoperative and intraoperative evaluation of the native ACL (both anteromedial and posterolateral bundles), knee anatomy and function, level of activity and generalised ligamentous laxity are assessed. Femoral and tibial tunnels should be placed in their anatomical location accounting for both the native ACL insertion site and bony landmarks. Two groups will be created, one with patients undergoing ACL reconstruction based on a surgeon's experience and one based on a more individualised approach according to the particular characteristics of each patient separately. In addition, patients in the second group will undergo ACL reconstruction with the use of Computer Assisted System (Navigation).

Preoperatively and postoperatively, the patients will be assessed with the KT2000 system, the KOOS (Knee injury and Osteoarthritis Outcome), the Tegner- Lysholm Knee scoring system and the IKDC (International Knee Documentation Committee). Additionally, all patient will be examined for their knee function with the use of a 3D gait analysis system.

The follow-up examination will take place 6 and 12 months after the surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament Injuries

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ACL Anterior Cruciate Ligament Reconstruction Individualised Anatomical Navigation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups of patients, randomly assigned
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Convetional reconstruction group

Patients will undergo ACL reconstruction based on conventional ACL surgery

Group Type ACTIVE_COMPARATOR

Conventional ACL reconstruction

Intervention Type PROCEDURE

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

Individualised reconstruction group

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

Group Type EXPERIMENTAL

Individualised ACL reconstruction

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Individualised ACL reconstruction

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

Intervention Type PROCEDURE

Conventional ACL reconstruction

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* No previous surgery in the knee (except partial meniscectomy), no major systematic pathology
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Thessaly

OTHER

Sponsor Role collaborator

Larissa University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Georgios Chalatsis

MD, MSc, PhD Cand, Resident in Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Hantes, MD

Role: STUDY_CHAIR

University General Hospital of Larissa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Michael Hantes

Larissa, , Greece

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Greece

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Georgios Chalatsis, MD

Role: CONTACT

Phone: 00306977992086

Email: [email protected]

michael hantes, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gorgios Paraskevas Chalatsis, MD

Role: primary

Michael Hantes, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GC1

Identifier Type: -

Identifier Source: org_study_id