Anterior Cruciate Ligament InjuriesMIRRACLNCT04183803
Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction
A study testing anatomic anterior cruciate ligament (ACL) reconstruction in people with Anterior Cruciate Ligament Injuries, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Accurate ideal graft tunnel positioning is essential for the successful application of anatomic anterior cruciate ligament (ACL) reconstruction. The accurate insertion of the tibial tunnel (TT) and femoral tunnel (FT) remain a challenge. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- anatomic anterior cruciate ligament (ACL) reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2019to 30 Sep 2027
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients treated at CHU Amiens-Picardie for ACL reconstruction by practitioner who has robot experience.
- children and adults from 10 to 45 years old
Who cannot join
- Patients managed by another ACL reconstruction technique
- Patients under guardianship, curators deprived of liberty
- Pregnant and nursing women.
- Patient who refused to participate in the study and to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Francois Deroussen, MD, (33)322087576, deroussen.francois@chu-amiens.fr
Michel Lefranc, MD, (33)322088955, lefranc.michel@chu-amiens.fr
About this study
Accurate ideal graft tunnel positioning is essential for the successful application of anatomic anterior cruciate ligament (ACL) reconstruction. The accurate insertion of the tibial tunnel (TT) and femoral tunnel (FT) remain a challenge.
A robotic assisted new strategy for drill TT and FT in ACL reconstruction will be performed and its efficacy and accuracy will be assess.
The investigators will prospectively include 30 patients with ACL rupture requiring surgical treatment. The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®).
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- anatomic anterior cruciate ligament (ACL) reconstruction
- Keywords
- anterior cruciate ligament, reconstruction, robot, tunnel
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anatomic anterior cruciate ligament (ACL) reconstructionProcedure or surgery
The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®).
| Study group | Role | What they receive |
|---|---|---|
| rosa robot assistance | Experimental | Patients with ACL rupture requiring surgical treatment will be included. The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®). Receives: Procedure: anatomic anterior cruciate ligament (ACL) reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of tunnel positioning
Accuracy of tunnel positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion
Measured: Day 0; during the operation
Secondary outcomes (10)
Range of motion of the knee
Range of motion of the knee will be measured with IKCD score (International Knee Documentation Committee) IKCD score : The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Measured: day 0, during operation
Range of motion of the knee
Range of motion of the knee will be measured with IKCD score (International Knee Documentation Committee) IKCD score : The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Measured: up to 2 years; during follow-up
Range of motion of the knee
Range of motion of the knee will be measured with Lysholm (Lysholm Knee Score)
Lysholm Knee Score : measure the domain of functioning in sports and recreational activities. This scale consists of eight items. It is scored on a scale of 0 to 100, with higher scores indicating fewer symptoms and higher levels of functioning.
Measured: up to 2 years; during follow-up
Range of motion of the knee
Range of motion of the knee will be measured with Lysholm (Lysholm Knee Score)
Lysholm Knee Score : measure the domain of functioning in sports and recreational activities. This scale consists of eight items. It is scored on a scale of 0 to 100, with higher scores indicating fewer symptoms and higher levels of functioning.
Measured: day 0, during operation
Range of motion of the knee
Range of motion of the knee will be measured with ACL-RSI (Psychological ACL-RSI Score).
Psychological ACL-RSI Score : measure patient psychological impact. This test includes 12 questions. Higher score describes no knee pathology.
Measured: up to 2 years; during follow-up
Range of motion of the knee
Range of motion of the knee will be measured with ACL-RSI (Psychological ACL-RSI Score).
Psychological ACL-RSI Score : measure patient psychological impact. This test includes 12 questions. Higher score describes no knee pathology.
Measured: day 0, during operation
Knee stability
Knee stability will be measured with manual test : "pivot shift"
Measured: day 0; during operation
Knee stability
Knee stability will be measured with manual test : radiography images.
Measured: day 0; during operation
Knee stability
Knee stability will be measured with manual test : "pivot shift"
Measured: up to 2 years; during follow-up
Knee stability
Knee stability will be measured with manual test : radiography images.
Measured: up to 2 years; during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start19 Nov 2019
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Deroussen, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183803
- Sponsor's protocol ID
- PI2019_843_0029
- Acronym
- MIRRACL
- Status last verified
- May 2026
- First submitted
- 21 Nov 2019
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04183803
- Acronym / sponsor ID
- MIRRACL / PI2019_843_0029
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- anterior cruciate ligament, reconstruction, robot, tunnel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Dec 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.
Accurate ideal graft tunnel positioning is essential for the successful application of anatomic anterior cruciate ligament (ACL) reconstruction. The accurate insertion of the tibial tunnel (TT) and femoral tunnel (FT) remain a challenge.
A robotic assisted new strategy for drill TT and FT in ACL reconstruction will be performed and its efficacy and accuracy will be assess.
The investigators will prospectively include 30 patients with ACL rupture requiring surgical treatment. The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rosa robot assistance | Experimental | Procedure: anatomic anterior cruciate ligament (ACL) reconstructionPatients with ACL rupture requiring surgical treatment will be included. The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®). |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients treated at CHU Amiens-Picardie for ACL reconstruction by practitioner who has robot experience.
- children and adults from 10 to 45 years old
Key exclusion criteria (4 listed)
- Patients managed by another ACL reconstruction technique
- Patients under guardianship, curators deprived of liberty
- Pregnant and nursing women.
- Patient who refused to participate in the study and to sign informed consent
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 |
|---|---|---|
| anatomic anterior cruciate ligament (ACL) reconstructionThe reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®). | Procedure or surgery | rosa robot assistance |
Primary outcome
Accuracy of tunnel positioning
Time frame: Day 0; during the operation
Accuracy of tunnel positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion
10 secondary outcomes
Range of motion of the knee
Time frame: day 0, during operation
Range of motion of the knee
Time frame: up to 2 years; during follow-up
Range of motion of the knee
Time frame: up to 2 years; during follow-up
Range of motion of the knee
Time frame: day 0, during operation
Range of motion of the knee
Time frame: up to 2 years; during follow-up
Range of motion of the knee
Time frame: day 0, during operation
Knee stability
Time frame: day 0; during operation
Knee stability
Time frame: day 0; during operation
Knee stability
Time frame: up to 2 years; during follow-up
Knee stability
Time frame: up to 2 years; during follow-up
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 13 May 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.
François Deroussen, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anatomic anterior cruciate ligament (ACL) reconstruction in people with Anterior Cruciate Ligament Injuries, run by Centre Hospitalier Universitaire, Amiens 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 13 May 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 François Deroussen, MD ((33)322087576, deroussen.francois@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of tunnel positioning (time frame: Day 0; during the operation). 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 13 May 2026.