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Anterior Cruciate Ligament InjuriesNCT04136990

Does ACL Augmented With LEAT Better Controls Rotational Laxity Than Isolated ACL Reconstruction?

A study testing Isolated ACL reconstruction and ACL + LEAT reconstruction in people with Anterior Cruciate Ligament Injuries, run by Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

It has been suggested that adding a Lateral Extra-Articular Tenodesis (LEAT) to Anterior Cruciate Ligament (ACL) reconstruction has the advantage of better controlling the rotational laxity. Read more about this study

Who is it for?
Ages 15 to 25 years
Conditions the study is for
Anterior Cruciate Ligament Injuries
What is being tested?
Isolated ACL reconstruction and ACL + LEAT reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePortugal
Study dates
13 Jan 2020to Jun 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 15 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • no previous knee surgeries
  • contralateral healthy knee
  • positive pivot-shift (++)

Who cannot join

  • revision ACL surgery
  • ACL reconstruction using allograft or synthetic grafts
  • multi-ligament injury
  • pregnant female
  • other injuries or conditions that may alter the knee function (eg. severe osteoarthritis)
  • requiring concomitant osteotomy
  • requiring concomitant cartilage surgery (other than debridement)

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

    Porto, 4350-415

Other trials in Portugal

About this study

Official title: Comparison of Anterior Cruciate Ligament Isolated Reconstruction or Combined With Lateral Extra-articular Tenodesis in Knee Laxity, Graft Failure and Patient-reported Outcome Measures

It has been suggested that adding a Lateral Extra-Articular Tenodesis (LEAT) to Anterior Cruciate Ligament (ACL) reconstruction has the advantage of better controlling the rotational laxity. The objective of this study is to compare the the sagittal and rotational knee laxity using the Porto Knee Testing Device (PKTD) - a MRI-compatible arthrometer - at 2 years follow-up (side-to-side and to baseline comparison) in patients that underwent isolated ACL reconstruction (isolated ACL) versus ACL reconstruction combined with LEAT (ACL+LEAT). Patient-reported outcome measures using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and graft failure (re-tear) will also be assessed at 2 years follow-up.

Read the detailed description

This study is a non-randomized clinical trial including 40 patients with anterior cruciate ligament injury who are undergoing surgery and will be allocated 1:1 to either isolated ACL reconstruction (control group) or ACL reconstruction combined with lateral extra-articular tenodesis (experimental group). The principal outcome of this work is the sagittal and rotational knee laxity analysis and side-to-side and 2-year improvement. The secondary outcomes include graft failure (re-tears) and the patient-reported outcome measures (KOOS) at 2 years follow-up.

Being tested
Isolated ACL reconstruction, ACL + LEAT reconstruction
Keywords
Anterior Cruciate Ligament Reconstruction, Lateral Extra-Articular Tenodesis, Knee Laxity, Porto Knee Testing Device
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.

  • Isolated ACL reconstructionProcedure or surgery

    Isolated ACL reconstruction using the bone-patellar tendon autograft.

  • ACL + LEAT reconstructionProcedure or surgery

    ACL reconstruction using the bone-patella-tendon-bone autograft combined with LEAT using the mini Lemaire technique.

Study groups in NCT04136990
Study groupRoleWhat they receive
Isolated ACL reconstructionActive comparatorIsolated ACL reconstruction only.
Receives: Procedure: Isolated ACL reconstruction
ACL + LEATExperimentalACL reconstruction combined with Lateral Extra-Articular Tenodesis (LEAT).
Receives: Procedure: ACL + LEAT reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline of sagittal and rotational knee laxity

    To assess the post-operative knee sagittal and rotational laxity, we will use the Porto Knee Testing Device (PKTD). We will measure the anterior displacement on the medial and lateral plateaus and internal and external rotation in the lateral and medial plateau. Additionally, these measures will be combined to measure the anterior global translation (anterior translation on lateral + medial plateaus) and the global rotation (internal + external rotation in the lateral plateau).

    Measured: Baseline and 24 months

Secondary outcomes (3)

  1. Graft Failure

    Rate of graft failure. It will be considered only graft tears. We will determine the absolute risk of graft failure in each group, if enough data available.

    Measured: 24 months

  2. Change from baseline of Knee Osteoarthritis and Outcomes Score (KOOS)

    The KOOS is a 42-item knee-specific questionnaire with five separately reported domains, including pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sports/recreation (5 items) and knee-related quality of life (4 items). Domain scores represent the average of all items in the domain standardized to a score from 0 to 100 (worst to best).

    Measured: Baseline, 12 and 24 months

  3. Change from baseline of Tegner Scale

    The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10, developed for knee injuries (especially ACL injury).

    Measured: Baseline, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start13 Jan 2020
  3. Primary completionDec 2022 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Non-randomized 1:1 allocation
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04136990
Sponsor's protocol ID
0015/0019
Status last verified
Mar 2022
First submitted
18 Oct 2019
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Isolated ACL reconstruction and ACL + LEAT reconstruction in people with Anterior Cruciate Ligament Injuries, run by Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence at 1 site in Portugal.

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 3 inclusion and 7 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 22 Mar 2022. 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 Portugal. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of sagittal and rotational knee laxity (time frame: Baseline and 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04136990.

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 22 Mar 2022.

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