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

Deficiency of Anterior Cruciate Ligament Clinical Trial

— MRI-DT4  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02626975
• Other study ID #: 2013_50
• Secondary ID: 2014-A01413-44
• Status: Recruiting
• Start date: August 14, 2015
• Est. completion date: July 2019

Study information

• Verified date: November 2018
• Source: University Hospital, Lille
• Contact: Gilles PASQUIER, MD,PhD
• Email: gilles.pasquier[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Deficiency of Anterior Cruciate Ligament
• Displacement of Bone Allograft

Locations

Country	Name	City	State
France	University Hospital, Hôpital Salengro	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of balloonisation	oversize of the diameters of femoral and /or tibial tunnels more than 50% of their surgical diameter	1 year
Secondary	frequency of ligamentisation	fixation on MRI of gadolinium in ligament graft	1 year
Secondary	laximetry done with genurob*	measure of the residual anterior laxity on an electronic device	1 year
Secondary	Knee Injury and Osteoarthritis Outcome Score	clinical measures	1 year
Secondary	International Knee Documentation Commitee (IKDC) Score	clinical measures	1 year