Arthritis FootNCT04937764
Interest of Medial Partial Arthrodesis in Degenerative and Inflammatory Damage of Lisfranc Tarsometatarsal Joint.
An observational study of Arthritis Foot, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Research Hypothesis: Lisfranc tarsometatarsal joint arthrodesis is a reliable surgical procedure, allowing the restoration of satisfactory function and a painless foot with an acceptable complication rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Foot
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2008to 30 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent Lisfranc arthrodesis for primary post-traumatic osteoarthritis or inflammatory disease between January 2008 and December 2020 in the department of orthopeadic surgery of the CHU NANCY
Who may be able to join
- All patients who underwent Lisfranc arthrodesis for primary post-traumatic osteoarthritis or inflammatory disease between January 2008 and December 2020 in
- Age > 18 ans
Who cannot join
- Follow-up < 6 months
- Lost to follow-up
- lack of data in the patient record.
Trial locations and contacts
1 site in 1 country.
About this study
Research Hypothesis: Lisfranc tarsometatarsal joint arthrodesis is a reliable surgical procedure, allowing the restoration of satisfactory function and a painless foot with an acceptable complication rate.
Objective of the study: To analyze the clinical and radiographic results in the medium term of arthrodesis of the Lisfranc tarsometatarsal joint in cases of primary osteoarthritis, post-traumatic osteoarthritis or in cases of inflammatory pathology.
Read the detailed description
Data collection by return to the patient record:
- Clinical score
- Analysis of imagery (X-rays, CT scan, )
The patients included were those who had undergone arthrodesis of the medial Lisfranc joint
- Conditions
- Arthritis Foot
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 |
|---|---|---|
| Study population | Population who underwent a surgical arthrodesis procedure for arthritic or inflammatory involvement of the Lisfranc tarsometatarsal joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of the AOFAS score of the midfoot
AOFAS Score
Measured: 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start8 Apr 2008
- Primary completion27 Jan 2009
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis FootStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didier MAINARD, Central Hospital, Nancy, France
- Investigators
- Didier Mainard, Pr, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937764
- Sponsor's protocol ID
- 2021PI033
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing data
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Medial Partial Arthrodesis in Degenerative and Inflammatory Damage of Lisfranc Tarsometatarsal Joint.
- ClinicalTrials.gov ID
- NCT04937764
- Acronym / sponsor ID
- 2021PI033
- Conditions
- Arthritis Foot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 8 Apr 2008 (actual)
- Primary completion
- 27 Jan 2009 (actual)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 24 Jun 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.
Research Hypothesis: Lisfranc tarsometatarsal joint arthrodesis is a reliable surgical procedure, allowing the restoration of satisfactory function and a painless foot with an acceptable complication rate.
Objective of the study: To analyze the clinical and radiographic results in the medium term of arthrodesis of the Lisfranc tarsometatarsal joint in cases of primary osteoarthritis, post-traumatic osteoarthritis or in cases of inflammatory pathology.
Detailed description
Data collection by return to the patient record:
- Clinical score
- Analysis of imagery (X-rays, CT scan, )
The patients included were those who had undergone arthrodesis of the medial Lisfranc joint
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –Population who underwent a surgical arthrodesis procedure for arthritic or inflammatory involvement of the Lisfranc tarsometatarsal joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent Lisfranc arthrodesis for primary post-traumatic osteoarthritis or inflammatory disease between January 2008 and December 2020 in the department of orthopeadic surgery of the CHU NANCY
Key inclusion criteria (2 listed)
- All patients who underwent Lisfranc arthrodesis for primary post-traumatic osteoarthritis or inflammatory disease between January 2008 and December 2020 in
- Age > 18 ans
Key exclusion criteria (3 listed)
- Follow-up < 6 months
- Lost to follow-up
- lack of data in the patient record.
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
Clinical improvement of the AOFAS score of the midfoot
Time frame: 1 year post surgery
AOFAS Score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Individual participant dataSharing planned: No. No sharing data
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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.
Didier Mainard, Pr study director
Central Hospital, Nancy, France
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 Arthritis Foot, run by Central Hospital, Nancy, France 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 3 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 24 Jun 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?
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?
Clinical improvement of the AOFAS score of the midfoot (time frame: 1 year post surgery). 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 24 Jun 2021.