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

• Conditions: Deficiency of Anterior Cruciate Ligament; Displacement of Bone Allograft

• Registration Number: NCT02626975
• Lead Sponsor: University Hospital, Lille

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 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.

Study Timeline

• Study Start: 2015-08-14
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-08
• Last Update Posted: 2018-11-09
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
frequency of balloonisation	1 year	oversize of the diameters of femoral and /or tibial tunnels more than 50% of their surgical diameter

Secondary Outcome Measures

Name	Time	Method
frequency of ligamentisation	1 year	fixation on MRI of gadolinium in ligament graft
laximetry done with genurob*	1 year	measure of the residual anterior laxity on an electronic device
Knee Injury and Osteoarthritis Outcome Score	1 year	clinical measures
International Knee Documentation Commitee (IKDC) Score	1 year	clinical measures

Trial Locations

Locations (1)

University Hospital, Hôpital Salengro; 🇫🇷 Lille, France