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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02626975
Acronym
MRI-DT4
Enrollment
24
Registered
2015-12-10
Start date
2015-08-14
Completion date
2016-06-23
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deficiency of Anterior Cruciate Ligament, Displacement of Bone Allograft

Keywords

knee, short hamstring autograft, ligament, MRI

Brief summary

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.

Detailed description

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 balloonedone, 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 balloonedone.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
frequency of balloonisation1 yearoversize of the diameters of femoral and /or tibial tunnels more than 50% of their surgical diameter

Secondary

MeasureTime frameDescription
frequency of ligamentisation1 yearfixation on MRI of gadolinium in ligament graft
laximetry done with genurob*1 yearmeasure of the residual anterior laxity on an electronic device
Knee Injury and Osteoarthritis Outcome Score1 yearclinical measures
International Knee Documentation Commitee (IKDC) Score1 yearclinical measures

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026