Injury, KneeNCT03932838
Descriptive Study of Multiligamentary Reconstruction of the Knee
A study testing Clinical and radiologic evaluation in people with Injury, Knee, run by Versailles Hospital at 1 site in France.
Trial summary
Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft. There is currently little data in the clinical outcome literature after allograft reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury, Knee
- What is being tested?
- Clinical and radiologic evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 1 Jun 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients operated for one-time allograft or autograft reconstruction of multiligamentous knee injury
- >18 years old
Who cannot join
- Neurological or vascular injury during trauma.
- Fracture of the femur or both bones of the leg.
- Ligamentous lesion on the contralateral knee.
- History of surgery on the affected knee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.
Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft.
There is currently little data in the clinical outcome literature after allograft reconstruction. There is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). No study compares postoperative laxity after allograft versus autograft reconstruction.
- Conditions
- Injury, Knee
- Being tested
- Clinical and radiologic evaluation
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and radiologic evaluationOther
Follow up post surgery: clinical and radiologic evaluation
| Study group | Role | What they receive |
|---|---|---|
| clinical and radiologic evaluation | Experimental | Follow up post surgery: clinical and radiologic evaluation Receives: Other: Clinical and radiologic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint mobility of both knees
Postoperative knee function assessed by clinical examination
Measured: 2 years
Postoperative laxity in varus, valgus, anterior and posterior drawer
Postoperative knee function assessed by clinical examination
Measured: 2 years
Postoperative knee function assessed by scores
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Dec 2017
- Primary completion1 Dec 2019
- Study completion1 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury, KneeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Pujol, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932838
- Sponsor's protocol ID
- P17/12_ Reconstruction
- Status last verified
- Mar 2026
- First submitted
- 12 Apr 2019
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.
- ClinicalTrials.gov ID
- NCT03932838
- Acronym / sponsor ID
- P17/12_ Reconstruction
- Conditions
- Injury, Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jun 2035 (estimated)
- First posted
- 1 May 2019 (actual)
- 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.
Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft.
There is currently little data in the clinical outcome literature after allograft reconstruction. There is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). No study compares postoperative laxity after allograft versus autograft reconstruction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinical and radiologic evaluation | Experimental | Other: Clinical and radiologic evaluationFollow up post surgery: clinical and radiologic evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients operated for one-time allograft or autograft reconstruction of multiligamentous knee injury
- >18 years old
Key exclusion criteria (4 listed)
- Neurological or vascular injury during trauma.
- Fracture of the femur or both bones of the leg.
- Ligamentous lesion on the contralateral knee.
- History of surgery on the affected knee.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and radiologic evaluationFollow up post surgery: clinical and radiologic evaluation | Other | clinical and radiologic evaluation |
Primary outcome
Joint mobility of both knees
Time frame: 2 years
Postoperative knee function assessed by clinical examination
Postoperative laxity in varus, valgus, anterior and posterior drawer
Time frame: 2 years
Postoperative knee function assessed by clinical examination
Postoperative knee function assessed by scores
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and radiologic evaluation in people with Injury, Knee, run by Versailles Hospital 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Pujol (0139639565, npujol@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint mobility of both knees (time frame: 2 years). The study lists 3 primary outcomes in all. 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 17 Mar 2026.