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

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ClinicalTrials.gov Identifier: NCT04136990
Recruitment Status : Enrolling by invitation
First Posted : October 23, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

Tracking Information
First Submitted Date  ICMJE October 18, 2019
First Posted Date  ICMJE October 23, 2019
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE January 13, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
Change from baseline of sagittal and rotational knee laxity [ Time Frame: Baseline and 24 months ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04136990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
  • Graft Failure [ Time Frame: 24 months ]
    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.
  • Change from baseline of Knee Osteoarthritis and Outcomes Score (KOOS) [ Time Frame: Baseline, 12 and 24 months ]
    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).
  • Change from baseline of Tegner Scale [ Time Frame: Baseline, 12 and 24 months ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does ACL Augmented With LEAT Better Controls Rotational Laxity Than Isolated ACL Reconstruction?
Official Title  ICMJE Comparison of Anterior Cruciate Ligament Isolated Reconstruction or Combined With Lateral Extra-articular Tenodesis in Knee Laxity, Graft Failure and Patient-reported Outcome Measures
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Non-randomized 1:1 allocation
Masking: Single (Outcomes Assessor)
Masking Description:
Outcomes Assessor will be blinded to the patient group
Primary Purpose: Treatment
Condition  ICMJE Anterior Cruciate Ligament Injuries
Intervention  ICMJE
  • Procedure: Isolated ACL reconstruction
    Isolated ACL reconstruction using the bone-patellar tendon autograft.
  • Procedure: ACL + LEAT reconstruction
    ACL reconstruction using the bone-patella-tendon-bone autograft combined with LEAT using the mini Lemaire technique.
Study Arms  ICMJE
  • Active Comparator: Isolated ACL reconstruction
    Isolated ACL reconstruction only.
    Intervention: Procedure: Isolated ACL reconstruction
  • Experimental: ACL + LEAT
    ACL reconstruction combined with Lateral Extra-Articular Tenodesis (LEAT).
    Intervention: Procedure: ACL + LEAT reconstruction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 21, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04136990
Other Study ID Numbers  ICMJE 0015/0019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
Study Sponsor  ICMJE Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: João Espregueira-Mendes, MD, PhD Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
Principal Investigator: Renato Andrade Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
PRS Account Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP