UnknownNot Applicable

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

Portugal40 participantsStarted 2020-01-13

Plain-language 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.

Who can participate

Age range15 Years – 25 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Change from baseline of sagittal and rotational knee laxity

Timeframe: Baseline and 24 months

Trial details

NCT IDNCT04136990

SponsorEspregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12

View on ClinicalTrials.gov More Anterior Cruciate Ligament Injuries trials