Hallux Rigidus, Unspecified FootREPARNCT03622723
Radiological Stage and Efficacy of an Intra-articular Injection of Hyaluronic Acid for the Treatment of Hallux Rigidus
An observational study of Hallux Rigidus, Unspecified Foot, run by Labrha at 1 site in France.
Trial summary
The hallux rigidus is the most frequent type of arthrosis at the age of 50 and beyond. For the moderate forms of the disease, the majority of the studies recommend the recourse to the viscosupplement because of its efficiency in the long term. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hallux Rigidus, Unspecified Foot
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2016to Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sixty patients presenting a hallux rigidus asserted radiologically and justifying according to the opinion of the rhumalologist or the surgeon a viscosupplementation. The study is realized in the conditions of daily practice, it modifies not at all the therapeutic care of the patient
Who may be able to join
- • Patients of both genders, of all ages
- Hallux rigidus confirmed by radiography including frontal and side radiographies performed during the last 6 months
- Patients requiring a viscosupplement based on the opinion of the investigator
- Patients were able to read and understand the information sheet, to give their enlighted consent and to respect follow up consultations
Who cannot join
- Patient with hypersensitivity to hyaluronic acid or mannitol
- Patient with a contraindication to the injection procedure : infected skin lesions on or close to an injection site, infectious disease ongoing
- Patient who received a viscosuplement during the last 3 months
- Patient who received an intra-articular injection of corticoids in the target articulation during the month before the inclusion
- Patient not talking french
- Patients that must undergo a surgical operation planned during 3 months following the injection susceptible to interfere with the follow-up or the evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Radiological Stage Allow to Predict the Efficacy of an Intra-articular Injection of Hyaluronic Acid Among Patients Affected by a Hallux Rigidus ?
The hallux rigidus is the most frequent type of arthrosis at the age of 50 and beyond. For the moderate forms of the disease, the majority of the studies recommend the recourse to the viscosupplement because of its efficiency in the long term.
On the other hand, no study was focused on the impact of the anatomical severity on the clinical result of the treatment by intra-articular injection of hyaluronic acid.
Read more
The present research has for objective to study the influence of the radiological severity on the result of the viscosupplement, in the conditions of daily practice, in patients affected by Hallux rigidus.
It is an open observational multicentrical prospective study realized by 20 investigators rheumatologists and liberal orthopedic surgeons. The recruitment is competitive and the study will be ended when 66 patients will have been included by taking into account a risk of trial exits or of lost of sight of 10 %.The main criterion is the influence of the radiological stage on the answer to the treatment.
Duration of inclusion 6 months. Duration of follow-up 3 months. Total duration of the study 9 months.
Read the detailed description
Sixty patients presenting a hallux rigidus asserted by radiography and justifying a viscosupplement, without other selection criterion than the opinion of the investigator concerning the legitimacy of a viscosupplement and the agreement of the patient participating in the study.
The data collected during the consultations at J0 and J90 will be inputed by the investigator in the paper version of the CRF.
The informations collected during the initial consultation (J0) are: demographic (sex, age, weight, size), pathological (history of the disease, bilaterality, surgery of the big toe, evaluation of pain at J0 (scale of Likert : 11 points), treatments with analgesic aim, use of an orthosis), radiologics (Dell's stage), techniques (type of radiological or ultrasound guide).
The informations collected during the final consultation (J90) are: the evaluation of pain at J90 (scale of Likert 11 points), the perception by the patient of the efficiency of the treatment at J90 (scale of Likert 4 points), variation of its consumption of analgesic or of AINS (scale of Likert 3 points).
A descriptive analysis will be performed to characterize the demographic data, the history of the disease and its treatments, as well as the clinical and radiological data of the patients in the date of the inclusion.
The answer to the treatment will be estimated by 2 modalities (YES/NO) from the answer of the patients at the question " How do you judge the efficiency of the treatment ?": yes if the patients answered "Effective" or "very effective", no if they answered "little effective" or "not effective".
The influence of the radiological stage on the answer to the treatment will be studied (main criterion). The influence of radiological stage on the level of pain at J0 and on the reduction of pain between J0 and J90 will also be studied.
The coefficients of the multivariate models (ANCOVA and mixed model) will be considered as significant if their p-value is inferior to the threshold of 5%.
- Conditions
- Hallux Rigidus, Unspecified Foot
- Keywords
- hallux rigidus, viscosupplementation, hyaluronic acid, metartarsophalangeal joint, foot arthritis, osteoarthritis of the big toe
- Medical subject headings
- Hallux Rigidus
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the radiological stage and the treatment response
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start19 Apr 2016
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Rigidus, Unspecified FootStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labrha
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- thierry CONROZIER, MD, Principal investigator, Labrha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622723
- Sponsor's protocol ID
- 2015-A01904-45
- Acronym
- REPAR
- Status last verified
- Aug 2018
- First submitted
- 5 Mar 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Radiological Stage Allow to Predict the Efficacy of an Intra-articular Injection of Hyaluronic Acid Among Patients Affected by a Hallux Rigidus ?
- ClinicalTrials.gov ID
- NCT03622723
- Acronym / sponsor ID
- REPAR / 2015-A01904-45
- Conditions
- Hallux Rigidus, Unspecified Foot
- Keywords
- hallux rigidus, viscosupplementation, hyaluronic acid, metartarsophalangeal joint, foot arthritis, osteoarthritis of the big toe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- LabrhaIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Aug 2018 (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 hallux rigidus is the most frequent type of arthrosis at the age of 50 and beyond. For the moderate forms of the disease, the majority of the studies recommend the recourse to the viscosupplement because of its efficiency in the long term.
On the other hand, no study was focused on the impact of the anatomical severity on the clinical result of the treatment by intra-articular injection of hyaluronic acid.
The present research has for objective to study the influence of the radiological severity on the result of the viscosupplement, in the conditions of daily practice, in patients affected by Hallux rigidus.
It is an open observational multicentrical prospective study realized by 20 investigators rheumatologists and liberal orthopedic surgeons. The recruitment is competitive and the study will be ended when 66 patients will have been included by taking into account a risk of trial exits or of lost of sight of 10 %.The main criterion is the influence of the radiological stage on the answer to the treatment.
Duration of inclusion 6 months. Duration of follow-up 3 months. Total duration of the study 9 months.
Detailed description
Sixty patients presenting a hallux rigidus asserted by radiography and justifying a viscosupplement, without other selection criterion than the opinion of the investigator concerning the legitimacy of a viscosupplement and the agreement of the patient participating in the study.
The data collected during the consultations at J0 and J90 will be inputed by the investigator in the paper version of the CRF.
The informations collected during the initial consultation (J0) are: demographic (sex, age, weight, size), pathological (history of the disease, bilaterality, surgery of the big toe, evaluation of pain at J0 (scale of Likert : 11 points), treatments with analgesic aim, use of an orthosis), radiologics (Dell's stage), techniques (type of radiological or ultrasound guide).
The informations collected during the final consultation (J90) are: the evaluation of pain at J90 (scale of Likert 11 points), the perception by the patient of the efficiency of the treatment at J90 (scale of Likert 4 points), variation of its consumption of analgesic or of AINS (scale of Likert 3 points).
A descriptive analysis will be performed to characterize the demographic data, the history of the disease and its treatments, as well as the clinical and radiological data of the patients in the date of the inclusion.
The answer to the treatment will be estimated by 2 modalities (YES/NO) from the answer of the patients at the question " How do you judge the efficiency of the treatment ?": yes if the patients answered "Effective" or "very effective", no if they answered "little effective" or "not effective".
The influence of the radiological stage on the answer to the treatment will be studied (main criterion). The influence of radiological stage on the level of pain at J0 and on the reduction of pain between J0 and J90 will also be studied.
The coefficients of the multivariate models (ANCOVA and mixed model) will be considered as significant if their p-value is inferior to the threshold of 5%.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sixty patients presenting a hallux rigidus asserted radiologically and justifying according to the opinion of the rhumalologist or the surgeon a viscosupplementation. The study is realized in the conditions of daily practice, it modifies not at all the therapeutic care of the patient
Key inclusion criteria (4 listed)
- • Patients of both genders, of all ages
Key exclusion criteria (6 listed)
- Patient with hypersensitivity to hyaluronic acid or mannitol
- Patient with a contraindication to the injection procedure : infected skin lesions on or close to an injection site, infectious disease ongoing
- Patient who received a viscosuplement during the last 3 months
- Patient who received an intra-articular injection of corticoids in the target articulation during the month before the inclusion
- Patient not talking french
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
Correlation between the radiological stage and the treatment response
Time frame: 3 months
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 9 Aug 2018.
- Individual participant dataSharing planned: No
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.
thierry CONROZIER, MD principal investigator
Labrha
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 Hallux Rigidus, Unspecified Foot, run by Labrha 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 4 inclusion and 6 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 9 Aug 2018. 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?
Correlation between the radiological stage and the treatment response (time frame: 3 months). 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 9 Aug 2018.