Deficiency of Anterior Cruciate LigamentMRI-DT4NCT02626975
MRI Study of Ballooning and Ligamentisation Short Transplants ACL Hamstring According to Technical DT4
An observational study of Deficiency of Anterior Cruciate Ligament and Displacement of Bone Allograft, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Deficiency of Anterior Cruciate Ligament, Displacement of Bone Allograft
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 14 Aug 2015to 23 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with an hamstring ACL ligamentoplasty with a follow up of at least 1 year
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- knee, short hamstring autograft, ligament, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACL reconstruction ballooning | ACL reconstruction with short hamstring tendon autograft * arm ballooning * arm no ballooning |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of balloonisation
oversize of the diameters of femoral and /or tibial tunnels more than 50% of their surgical diameter
Measured: 1 year
Secondary outcomes (4)
frequency of ligamentisation
fixation on MRI of gadolinium in ligament graft
Measured: 1 year
laximetry done with genurob*
measure of the residual anterior laxity on an electronic device
Measured: 1 year
Knee Injury and Osteoarthritis Outcome Score
clinical measures
Measured: 1 year
International Knee Documentation Commitee (IKDC) Score
clinical measures
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start14 Aug 2015
- Primary completion23 Jun 2016
- Study completion23 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficiency of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles PASQUIER, MD, PhD, Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626975
- Sponsor's protocol ID
- 2013_50
- Other IDs
- 2014-A01413-44
- Acronym
- MRI-DT4
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2015
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Study of Ballooning and Ligamentisation Short Transplants ACL Hamstring According to Technical DT4
- ClinicalTrials.gov ID
- NCT02626975
- Acronym / sponsor ID
- MRI-DT4 / 2013_50
- Keywords
- knee, short hamstring autograft, ligament, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 14 Aug 2015 (actual)
- Primary completion
- 23 Jun 2016 (actual)
- Study completion
- 23 Jun 2016 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL reconstruction ballooning | – | –ACL reconstruction with short hamstring tendon autograft * arm ballooning * arm no ballooning |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with an hamstring ACL ligamentoplasty with a follow up of at least 1 year
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- follow up inferior of 1 year
- absolute contraindication to knee MRI
- gadolinium allergy
- severe renal failure
- non isolated ACL ligamentoplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
frequency of balloonisation
Time frame: 1 year
oversize of the diameters of femoral and /or tibial tunnels more than 50% of their surgical diameter
4 secondary outcomes
frequency of ligamentisation
Time frame: 1 year
laximetry done with genurob*
Time frame: 1 year
Knee Injury and Osteoarthritis Outcome Score
Time frame: 1 year
International Knee Documentation Commitee (IKDC) Score
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles PASQUIER, MD, PhD study chair
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deficiency of Anterior Cruciate Ligament and Displacement of Bone Allograft, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of balloonisation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.