Ankle OsteoarthritisSCED-SANCT04312373
Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis
An observational study of Ankle Osteoarthritis, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
Trial summary
Ankle osteoarthritis (AOA) is a typical long-term complication of an ankle injury. Pain during walking is the main symptom that limits walking distance. Non-surgical treatments could be used to decrease pain. The gold standard treatment for end-stage OA is definitive surgical ankle arthrodesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Osteoarthritis
- What is being tested?
- Ankle Foot Orthosis
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2017to 30 Dec 2017
- 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: Patients suffering from AOA
Who may be able to join
- primary or post-traumatic one-sided Ankle osteoarthritis (AOA)
- Able to walk at least two minutes
Who cannot join
- cardiovascular diseases
- respiratory diseases that prevent subjects from performing the walking tests
- neurologic or orthopaedic diseases which could affect their gait (excluding AOA)
- inability to understand study instructions
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54000
About this study
Ankle osteoarthritis (AOA) is a typical long-term complication of an ankle injury. Pain during walking is the main symptom that limits walking distance. Non-surgical treatments could be used to decrease pain. The gold standard treatment for end-stage OA is definitive surgical ankle arthrodesis.
The purpose of this study was to assess the effectiveness of a rigid ankle-foot orthosis (R-AFO) for walking pain in a population suffering from AOA.
Read the detailed description
This study used the SCED introduction/withdrawal methodology to assess the efficacy of R-AFO on pain and walking distance in the 2-minute walk test (2MWT). Each patient is his or her own comparator. During phase A, considered as the baseline, the patient performs the 2MWT without R-AFO. During phases B, considered as the introduction phases, the patient performs the tests with R-AFO. These tests are performed repeatedly and at regular intervals. The time of transition between phases has been randomized to have a minimum of 3 trials per phase.
At the end of each test, an visual analogue scale for the pain and the walking distance travelled during the 2MWT were recorded.
- Conditions
- Ankle Osteoarthritis
- Being tested
- Ankle Foot Orthosis
- Keywords
- Ankle Osteoarthritis, Ankle Foot Orthosis, Ankle Arthrodesis, Single Case Experimental Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Foot OrthosisOther
According to the SCED methodology, patients were fitted with ankle foot orthosis intermittently, during 4 phases, in the following order : without orthosis (A1), with orthosis (B1), again without orthosis (A2) and again with orthosis (B2).
All the phases were carried out over one day.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the distance travelled during the 2MWT between each phase
In m.
Measured: 1 day, starting from the baseline
Evolution of the Visual Analogue Scale (VAS) for walking ankle pain between each phase
Scale from 0 to 10, the higher the score the higher the pain.
Measured: The VAS was performed after each 2MWT. All 2MWT were completed in one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Feb 2017
- Primary completion1 Nov 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle OsteoarthritisStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Paysant, PhD-MD, Study chair, Institut Régional de Médecine Physique et de Réadaptation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312373
- Sponsor's protocol ID
- IRR-2018-SCED
- Acronym
- SCED-SA
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2020
- Last updated
- 18 Mar 2020
- 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis
- ClinicalTrials.gov ID
- NCT04312373
- Acronym / sponsor ID
- SCED-SA / IRR-2018-SCED
- Conditions
- Ankle Osteoarthritis
- Keywords
- Ankle Osteoarthritis, Ankle Foot Orthosis, Ankle Arthrodesis, Single Case Experimental Design
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 18 Mar 2020 (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.
Ankle osteoarthritis (AOA) is a typical long-term complication of an ankle injury. Pain during walking is the main symptom that limits walking distance. Non-surgical treatments could be used to decrease pain. The gold standard treatment for end-stage OA is definitive surgical ankle arthrodesis.
The purpose of this study was to assess the effectiveness of a rigid ankle-foot orthosis (R-AFO) for walking pain in a population suffering from AOA.
Detailed description
This study used the SCED introduction/withdrawal methodology to assess the efficacy of R-AFO on pain and walking distance in the 2-minute walk test (2MWT). Each patient is his or her own comparator. During phase A, considered as the baseline, the patient performs the 2MWT without R-AFO. During phases B, considered as the introduction phases, the patient performs the tests with R-AFO. These tests are performed repeatedly and at regular intervals. The time of transition between phases has been randomized to have a minimum of 3 trials per phase.
At the end of each test, an visual analogue scale for the pain and the walking distance travelled during the 2MWT were recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from AOA
Key inclusion criteria (2 listed)
- primary or post-traumatic one-sided Ankle osteoarthritis (AOA)
- Able to walk at least two minutes
Key exclusion criteria (4 listed)
- cardiovascular diseases
- respiratory diseases that prevent subjects from performing the walking tests
- neurologic or orthopaedic diseases which could affect their gait (excluding AOA)
- inability to understand study instructions
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 |
|---|---|---|
| Ankle Foot OrthosisAccording to the SCED methodology, patients were fitted with ankle foot orthosis intermittently, during 4 phases, in the following order : without orthosis (A1), with orthosis (B1), again without orthosis (A2) and again with orthosis (B2). All the phases were carried out over one day. | Other | – |
Primary outcome
Evolution of the distance travelled during the 2MWT between each phase
Time frame: 1 day, starting from the baseline
In m.
Evolution of the Visual Analogue Scale (VAS) for walking ankle pain between each phase
Time frame: The VAS was performed after each 2MWT. All 2MWT were completed in one day.
Scale from 0 to 10, the higher the score the higher the pain.
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 18 Mar 2020.
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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.
Jean Paysant, PhD-MD study chair
Institut Régional de Médecine Physique et de Réadaptation
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 Ankle Osteoarthritis, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est 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: finished, as of the sponsor's last update on 18 Mar 2020. 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?
Evolution of the distance travelled during the 2MWT between each phase (time frame: 1 day, starting from the baseline). The study lists 2 primary outcomes in all. 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 18 Mar 2020.