Anterior Cruciate Ligament InjuriesIACLRNCT04366362
Individualized Anterior Cruciate Ligament Versus Conventional Reconstruction
A study testing Individualised ACL reconstruction and Conventional ACL reconstruction in people with Anterior Cruciate Ligament Injuries, run by Larissa University Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Individualised ACL reconstruction and Conventional ACL reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 2 Mar 2020to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with ACL rupture undergoing ACL reconstruction surgery with closed epiphyses, younger than 45 years old
Who cannot join
- No previous surgery in the knee (except partial meniscectomy), no major systematic pathology
Trial locations and contacts
1 site in 1 country.
michael hantes, MD contact
Greece1 site, 1 recruiting
- Recruiting
Michael Hantes
Larissa
Gorgios Paraskevas Chalatsis, MD, 0030 6977992086, ghalatsis@hotmail.com
Michael Hantes, MD, hantesmi@otenet.gr
About this study
Official title: Anterior Cruciate Ligament Surgical Reconstruction Based on Individualized Musculoskeletal Models: a Randomized Control Trial
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.
Read the detailed description
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
- Anterior Cruciate Ligament Injuries
- Being tested
- Individualised ACL reconstruction, Conventional ACL reconstruction
- Keywords
- ACL, Anterior, Cruciate, Ligament, Reconstruction, Individualised, Anatomical, Navigation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised ACL reconstructionProcedure or surgery
ACL reconstruction based on anatomical and functional distinctiveness of each patient separately
Conventional ACL reconstructionProcedure or surgery
ACL reconstruction based on surgeons experience without taking into account any other patients characteristics
| Study group | Role | What they receive |
|---|---|---|
| Convetional reconstruction group | Active comparator | Patients will undergo ACL reconstruction based on conventional ACL surgery Receives: 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 Receives: Procedure: Individualised ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Originally published in 1998 in The Journal of Orthopaedic and Sports Physical Therapy, the Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: 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.
the International Knee Documentation Committee Subjective Knee Form (IKDC) was designed to assess patients with a variety of knee disorders including ligamentous and meniscal injuries as well as patellofemoral pain and osteoarthritis. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 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.
Lysholm Knee Scoring Scale was designed to be used for evaluating outcomes of knee ligament surgery, particularly for symptoms related to instability. The Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Measured: Baseline and 1 year post operation
Compare the post operation MRI of the 2 groups
Evaluate tunnel positioning in femur and tibia and the graft integration and compare them between the 2 groups.
Measured: 1 year post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start2 Mar 2020
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of patients, randomly assigned
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly
- Responsible party
- Principal investigator, Georgios Chalatsis, Larissa University Hospital
- Investigators
- Michael Hantes, MD, Study chair, University General Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366362
- Sponsor's protocol ID
- GC1
- Acronym
- IACLR
- Status last verified
- Nov 2021
- First submitted
- 10 Jun 2019
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligament Surgical Reconstruction Based on Individualized Musculoskeletal Models: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04366362
- Acronym / sponsor ID
- IACLR / GC1
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- ACL, Anterior, Cruciate, Ligament, Reconstruction, Individualised, Anatomical, Navigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Collaborators
- University of Thessaly
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups of patients, randomly assigned
| Arm | Type | Receives |
|---|---|---|
| Convetional reconstruction group | Active comparator | Procedure: Conventional ACL reconstructionPatients will undergo ACL reconstruction based on conventional ACL surgery |
| Individualised reconstruction group | Experimental | Procedure: Individualised ACL reconstructionPatients will undergo ACL reconstruction based on their special anatomical and functional characteristics and with the use of a navigation system |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with ACL rupture undergoing ACL reconstruction surgery with closed epiphyses, younger than 45 years old
Key exclusion criteria (1 listed)
- No previous surgery in the knee (except partial meniscectomy), no major systematic pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualised ACL reconstructionACL reconstruction based on anatomical and functional distinctiveness of each patient separately | Procedure or surgery | Individualised reconstruction group |
| Conventional ACL reconstructionACL reconstruction based on surgeons experience without taking into account any other patients characteristics | Procedure or surgery | Convetional reconstruction group |
Primary outcome
Comparison of the change of stability of the operated knee between the two groups from Baseline until 1 year post-operation
Time frame: Baseline and 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.
4 secondary outcomes
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
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 1 year post operation
Compare the post operation MRI of the 2 groups
Time frame: 1 year post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
michael hantes, MD contact
Michael Hantes, MD study chair
University General Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualised ACL reconstruction and Conventional ACL reconstruction in people with Anterior Cruciate Ligament Injuries, run by Larissa University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios Chalatsis, MD (00306977992086, ghalatsis@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the change of stability of the operated knee between the two groups from Baseline until 1 year post-operation (time frame: Baseline and 1 year post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.