Chronic Ankle InstabilityALSACENCT06228378
Comparative Spectroscopic Analysis of Synovial Fluid From the Stable and Unstable Ankle
A study testing Raman microspectroscopy in people with Chronic Ankle Instability, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
A population of patients with chronic ankle instability for whom arthroscopic ligament stabilisation was indicated. Main objective: to use the Raman microspectroscopy technique to characterise the synovial fluid of the unstable ankle in comparison with the synovial fluid of the healthy ankle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Raman microspectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2023to 28 Jan 2025
- 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 aged 18 or over who have signed their consent to participate in the study
- Patients with chronic unilateral lateral ankle instability
- Patients who have not responded to medical treatment and for whom arthroscopic stabilisation of the ankle is planned.
Who cannot join
- Any history, anomaly or symptom relating to the contralateral ankle
- Patient under court protection, guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
A population of patients with chronic ankle instability for whom arthroscopic ligament stabilisation was indicated.
Main objective: to use the Raman microspectroscopy technique to characterise the synovial fluid of the unstable ankle in comparison with the synovial fluid of the healthy ankle.
Read the detailed description
Single-centre, prospective, open-label study of patients undergoing ankle stabilisation surgery.
Patients will participate in the study for six months. Three arthrocentheses with synovial fluid sampling will be performed Two at D0: on the healthy ankle and the pathological ankle One at M6: on the operated ankle A follow-up visit will take place 10 days after the arthrocentesis performed at D0 and after the one performed at M6. The purpose of these visits, which are carried out systematically by the centre's doctors as part of the surgical procedures, is to check that there are no complications.
- Conditions
- Chronic Ankle Instability
- Being tested
- Raman microspectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raman microspectroscopyOther
Raman microspectroscopy is a non-destructive method for observing and characterising the molecular composition and external structure of a biological sample based on the phenomenon of inelastic light scattering (Raman effect).
| Study group | Role | What they receive |
|---|---|---|
| Unstable ankle | Experimental | Unstable ankle Receives: Other: Raman microspectroscopy |
| Stable ankle | Active comparator | Not described Receives: Other: Raman microspectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral intensity of synovial fluid components
Spectral intensity of synovial fluid components :
Raman microspectroscopy is a non-destructive method for observing and characterising the molecular composition and external structure of a biological sample based on the phenomenon of inelastic light scattering.
Four regions of interest (ROIs) are defined at the four cardinal points in the peripheral zone where the pre-concentration of solutes is maximal. Six points are mapped in each ROI. Each drop is thus defined by 4 x 6 points, making it possible to check intra- and inter-ROI homogeneity. Spectral acquisitions were carried out after illumination by a laser source.
The mean spectrum of each LS drop is defined as the average of the four mean spectra of the ROIs, originating from the four cardinal points of the drop. The component Raman bands are identified and assigned on the basis of bibliographic data.
Measured: Month 6
Secondary outcomes (3)
Functional criterion (American Orthopaedic Foot and Ankle Society-AOFAS score)
Functional criterion (AOFAS score)
Measured: Month 6
Tribological criteria (drop surface measurement)
Tribological criteria (drop surface measurement)
Measured: Month 6
Tribological criteria (drop thickness measurement)
Tribological criteria (drop thickness measurement)
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start26 Sep 2023
- Primary completion28 Jan 2025
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-centre, open-label study of patients undergoing ankle stabilisation surgery.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre HARDY, MD, Principal investigator, Clinique du sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228378
- Sponsor's protocol ID
- 2022-A01300-43
- Acronym
- ALSACE
- Status last verified
- Apr 2025
- First submitted
- 14 Dec 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Spectroscopic Analysis of Synovial Fluid From the Stable and Unstable Ankle
- ClinicalTrials.gov ID
- NCT06228378
- Acronym / sponsor ID
- ALSACE / 2022-A01300-43
- Conditions
- Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 29 Jan 2024 (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.
A population of patients with chronic ankle instability for whom arthroscopic ligament stabilisation was indicated.
Main objective: to use the Raman microspectroscopy technique to characterise the synovial fluid of the unstable ankle in comparison with the synovial fluid of the healthy ankle.
Detailed description
Single-centre, prospective, open-label study of patients undergoing ankle stabilisation surgery.
Patients will participate in the study for six months. Three arthrocentheses with synovial fluid sampling will be performed Two at D0: on the healthy ankle and the pathological ankle One at M6: on the operated ankle A follow-up visit will take place 10 days after the arthrocentesis performed at D0 and after the one performed at M6. The purpose of these visits, which are carried out systematically by the centre's doctors as part of the surgical procedures, is to check that there are no complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single-centre, open-label study of patients undergoing ankle stabilisation surgery.
| Arm | Type | Receives |
|---|---|---|
| Unstable ankle | Experimental | Other: Raman microspectroscopyUnstable ankle |
| Stable ankle | Active comparator | Other: Raman microspectroscopy |
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 aged 18 or over who have signed their consent to participate in the study
- Patients with chronic unilateral lateral ankle instability
- Patients who have not responded to medical treatment and for whom arthroscopic stabilisation of the ankle is planned.
Key exclusion criteria (2 listed)
- Any history, anomaly or symptom relating to the contralateral ankle
- Patient under court protection, guardianship or curatorship
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 |
|---|---|---|
| Raman microspectroscopyRaman microspectroscopy is a non-destructive method for observing and characterising the molecular composition and external structure of a biological sample based on the phenomenon of inelastic light scattering (Raman effect). | Other | Stable ankle, Unstable ankle |
Primary outcome
Spectral intensity of synovial fluid components
Time frame: Month 6
Spectral intensity of synovial fluid components : Raman microspectroscopy is a non-destructive method for observing and characterising the molecular composition and external structure of a biological sample based on the phenomenon of inelastic light scattering. Four regions of interest (ROIs) are defined at the four cardinal points in the peripheral zone where the pre-concentration of solutes is maximal. Six points are mapped in each ROI. Each drop is thus defined by 4 x 6 points, making it possible to check intra- and inter-ROI homogeneity. Spectral acquisitions were carried out after illumination by a laser source. The mean spectrum of each LS drop is defined as the average of the four mean spectra of the ROIs, originating from the four cardinal points of the drop. The component Raman bands are identified and assigned on the basis of bibliographic data.
3 secondary outcomes
Functional criterion (American Orthopaedic Foot and Ankle Society-AOFAS score)
Time frame: Month 6
Tribological criteria (drop surface measurement)
Time frame: Month 6
Tribological criteria (drop thickness measurement)
Time frame: Month 6
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 6 Apr 2025.
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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.
Alexandre HARDY, MD principal investigator
Clinique du sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raman microspectroscopy in people with Chronic Ankle Instability, 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 2 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 6 Apr 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?
Spectral intensity of synovial fluid components (time frame: Month 6). 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 6 Apr 2025.