NCT02626975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2016

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

December 7, 2015

Last Update Submit

December 8, 2025

Conditions

Displacement of Bone AllograftDeficiency of Anterior Cruciate Ligament

Keywords

kneeshort hamstring autograftligamentMRI

Outcome Measures

Primary Outcomes (1)

  • frequency of balloonisation

    oversize of the diameters of femoral and /or tibial tunnels more than 50% of their surgical diameter

    1 year

Secondary Outcomes (4)

  • frequency of ligamentisation

    1 year

  • laximetry done with genurob*

    1 year

  • Knee Injury and Osteoarthritis Outcome Score

    1 year

  • International Knee Documentation Commitee (IKDC) Score

    1 year

Study Arms (1)

ACL reconstruction ballooning

ACL reconstruction with short hamstring tendon autograft * arm ballooning * arm no ballooning

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Hôpital Salengro

Lille, France

Location

Study Officials

  • Gilles PASQUIER, MD, PhD

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 10, 2015

Study Start

August 14, 2015

Primary Completion

June 23, 2016

Study Completion

June 23, 2016

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)