NCT04136990

Brief 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. 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.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 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

October 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

October 18, 2019

Last Update Submit

March 21, 2022

Conditions

Anterior Cruciate Ligament Injuries

Keywords

Anterior Cruciate Ligament ReconstructionLateral Extra-Articular TenodesisKnee LaxityPorto Knee Testing Device

Outcome Measures

Primary Outcomes (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).

    Baseline and 24 months

Secondary Outcomes (3)

  • Graft Failure

    24 months

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

    Baseline, 12 and 24 months

  • Change from baseline of Tegner Scale

    Baseline, 12 and 24 months

Study Arms (2)

Isolated ACL reconstruction

ACTIVE COMPARATOR

Isolated ACL reconstruction only.

Procedure: Isolated ACL reconstruction

ACL + LEAT

EXPERIMENTAL

ACL reconstruction combined with Lateral Extra-Articular Tenodesis (LEAT).

Procedure: ACL + LEAT reconstruction

Interventions

Isolated ACL reconstructionPROCEDURE

Isolated ACL reconstruction using the bone-patellar tendon autograft.

Isolated ACL reconstruction
ACL + LEAT reconstructionPROCEDURE

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

ACL + LEAT

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Porto, 4350-415, Portugal

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • João Espregueira-Mendes, MD, PhD

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

    STUDY DIRECTOR

  • Renato Andrade

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor will be blinded to the patient group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-randomized 1:1 allocation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 23, 2019

Study Start

January 13, 2020

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)