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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• France
  • Lille, France
    • University Hospital, Hôpital Salengro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with an hamstring ACL ligamentoplasty with a follow up of at least 1 year

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ACL reconstruction ballooning; ACL reconstruction with short hamstring tendon autograft; arm ballooning; arm no ballooning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of balloonisation	oversize of the diameters of femoral and /or tibial tunnels more than 50% of their surgical diameter	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Study Chair: Gilles PASQUIER, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2015
• Primary Completion (Actual): June 23, 2016
• Study Completion (Actual): June 23, 2016

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimated): December 10, 2015

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: MRI; knee; ligament; short hamstring autograft
• Other Study ID Numbers: 2013_50; 2014-A01413-44 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO