ACLNCT05123456
Risk of Osteoarthritis of the Knee at Least 5 Years After ACL Reconstruction: Comparative Study Between an Isolated ACL Reconstruction and a Reconstruction Combining ACL and ALL
A study testing Radiography in people with ACL and Anterior Curciate Ligament, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The main objective of this study is to compare, with a minimum follow-up of 5 years, the prevalence of femoro-tibial osteoarthritis after an isolated ACL ligamentoplasty or after an ACL ligamentoplasty combining ACL and ALL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL, Anterior Curciate Ligament, Anterolateral Ligament
- What is being tested?
- Radiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2020to 15 Dec 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent an isolated Anterior Cruciate Ligament (ACL) reconstruction or a combined ACL and anterolateral ligament reconstruction (Extra Articular Plasty) between January 1, 2011 and March 31, 2012.
- Patients affiliated or beneficiaries of a social security scheme
- Patients who have given their express consent.
Who cannot join
- Patients with pediatric ACL reconstruction technique
- Patients with a complex associated gesture such as osteotomy or ligamentoplasty other than extra articular plastic surgery.
- Contraindication to a radio control (pregnancy)
- Patient's refusal to participate in the study
- Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Hopital privé Jean Mermoz
Lyon, 69008
Bertrand SONNERY COTTET, Dr, +33 (0)4 37 53 00 24, sonnerycottet@aol.com
About this study
The main objective of this study is to compare, with a minimum follow-up of 5 years, the prevalence of femoro-tibial osteoarthritis after an isolated ACL ligamentoplasty or after an ACL ligamentoplasty combining ACL and ALL.
- Conditions
- ACL, Anterior Curciate Ligament, Anterolateral Ligament, Knee Injuries, ALL
- Being tested
- Radiography
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiographyProcedure or surgery
Comparative X-ray of the single knee at 30 ° flexion.
| Study group | Role | What they receive |
|---|---|---|
| Patient operated with isolated ACL knee reconstruction | Experimental | Not described Receives: Procedure: Radiography |
| Patient operated with ACL and ALL knee reconstruction | Experimental | Not described Receives: Procedure: Radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the prevalence of femoro-tibial osteoarthritis
The prevalence of femoro-tibial osteoarthritis will be assessed by the percentage of patients with cartilage damage to the femoro-tibial compartments on a single X-ray of the face compared to 30 °of flexion.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start15 Apr 2020
- Primary completion15 Apr 2021
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACLStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Private Hospital Jean Mermoz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123456
- Sponsor's protocol ID
- 2018-A02447-48
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shatrov J, Freychet B, Hopper GP, Coulin B, El Helou A, An JS, Vieira TD, Sonnery-Cottet B. Radiographic Incidence of Knee Osteoarthritis After Isolated ACL Reconstruction Versus Combined ACL and ALL Reconstruction: A Prospective Matched Study From the SANTI Study Group. Am J Sports Med. 2023 Jun;51(7):1686-1697. doi: 10.1177/03635465231168899. Epub 2023 May 8.
PubMed 37154412
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Osteoarthritis of the Knee at Least 5 Years After ACL Reconstruction: Comparative Study Between an Isolated ACL Reconstruction and a Reconstruction Combining ACL and ALL
- ClinicalTrials.gov ID
- NCT05123456
- Acronym / sponsor ID
- 2018-A02447-48
- Conditions
- ACL, Anterior Curciate Ligament, Anterolateral Ligament, Knee Injuries, ALL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Private Hospital Jean Mermoz
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 17 Nov 2021 (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.
The main objective of this study is to compare, with a minimum follow-up of 5 years, the prevalence of femoro-tibial osteoarthritis after an isolated ACL ligamentoplasty or after an ACL ligamentoplasty combining ACL and ALL.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient operated with isolated ACL knee reconstruction | Experimental | Procedure: Radiography |
| Patient operated with ACL and ALL knee reconstruction | Experimental | Procedure: Radiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who underwent an isolated Anterior Cruciate Ligament (ACL) reconstruction or a combined ACL and anterolateral ligament reconstruction (Extra Articular Plasty) between January 1, 2011 and March 31, 2012.
- Patients affiliated or beneficiaries of a social security scheme
- Patients who have given their express consent.
Key exclusion criteria (5 listed)
- Patients with pediatric ACL reconstruction technique
- Patients with a complex associated gesture such as osteotomy or ligamentoplasty other than extra articular plastic surgery.
- Contraindication to a radio control (pregnancy)
- Patient's refusal to participate in the study
- Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without 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 |
|---|---|---|
| RadiographyComparative X-ray of the single knee at 30 ° flexion. | Procedure or surgery | Patient operated with ACL and ALL knee reconstruction, Patient operated with isolated ACL knee reconstruction |
Primary outcome
Assessment of the prevalence of femoro-tibial osteoarthritis
Time frame: 1 day
The prevalence of femoro-tibial osteoarthritis will be assessed by the percentage of patients with cartilage damage to the femoro-tibial compartments on a single X-ray of the face compared to 30 °of flexion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Derived from this study: PubMed 37154412Shatrov J, Freychet B, Hopper GP, Coulin B, El Helou A, An JS, Vieira TD, Sonnery-Cottet B. Radiographic Incidence of Knee Osteoarthritis After Isolated ACL Reconstruction Versus Combined ACL and ALL Reconstruction: A Prospective Matched Study From the SANTI Study Group. Am J Sports Med. 2023 Jun;51(7):1686-1697. doi: 10.1177/03635465231168899. Epub 2023 May 8.
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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.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiography in people with ACL and Anterior Curciate Ligament, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 5 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: status not confirmed, as of the sponsor's last update on 17 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the prevalence of femoro-tibial osteoarthritis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05123456, which also lists 1 linked publication.
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 Nov 2021.