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NCT Number: NCT02626975

MRI Study of Ballooning and Ligamentisation Short Transplants ACL Hamstring According to Technical DT4

MRI study of ballooning and ligamentisation short transplants of anterior cruciate ligament (ACL) according to DT4 technique in 60 patients with more than one year of follow up.

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Key information

Conditions

Deficiency of Anterior Cruciate Ligament Displacement of Bone Allograft

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Hôpital Salengro

Lille, France

About this study

Monocentric study in the CHRU Lille in which the first goal is to estimate the frequency of tunnel's ballooning in a surgical anterior cruciate ligament reconstruction using short transplants of hamstrings.

the secondary goals Secondary goals of this study are the estimation of ligamentisation if ballooning or not, the comparison of sagittal laximetry between "ballooned" group and "not ballooned"one, the clinical results in IKDC score (International Knee Documentation Committee subjective fee form) and KOOS (Knee injury Osteoarthritis Outcome Score) between the "ballooned" group and the "not ballooned"one.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients of both sexes with an hamstring ACL ligamentoplasty done in our institution with a follow up of 1 year
  • isolated ACL ligamentoplasty
  • insured patients with a signed informed consent

Exclusion criteria

  • follow up inferior of 1 year
  • absolute contraindication to knee MRI
  • gadolinium allergy
  • severe renal failure
  • non isolated ACL ligamentoplasty
  • patient under guardianship, minor
  • pregnant woman or nursing mother

Treatment and study plan

Primary outcomes

  1. frequency of balloonisation

    Time frame: 1 year

    oversize of the diameters of femoral and /or tibial tunnels more than 50% of their surgical diameter

Secondary outcomes

  1. frequency of ligamentisation

    Time frame: 1 year

    fixation on MRI of gadolinium in ligament graft

  2. laximetry done with genurob*

    Time frame: 1 year

    measure of the residual anterior laxity on an electronic device

  3. Knee Injury and Osteoarthritis Outcome Score

    Time frame: 1 year

    clinical measures

  4. International Knee Documentation Commitee (IKDC) Score

    Time frame: 1 year

    clinical measures

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: MRI-DT4

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 10, 2015
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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