MRI Study of Ballooning and Ligamentisation Short Transpl... | NCT02626975

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

NCT02626975

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Dec 16, 2025Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Deficiency of Anterior Cruciate Ligament
Displacement of Bone Allograft

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-A01413-44	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2015Actual

Primary Completion Date

Jun 23, 2016Actual

Completion Date

Jun 23, 2016Actual

First Submitted Date

Dec 7, 2015

First Submission Date that Met QC Criteria

Dec 7, 2015

First Posted Date

Dec 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2025

Last Update Posted Date

Dec 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACL reconstruction ballooning		ACL reconstruction with short hamstring tendon autograft arm ballooning arm no ballooning

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gilles PASQUIER, MD, PhD	University Hospital, Lille	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Hôpital Salengro		Lille			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided