Chronic Ankle InstabilityNCT04961892
Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for CAI
An observational study of Chronic Ankle Instability, run by Peking University Third Hospital at 1 site in China.
Trial summary
The objective of this study was to compare the difference of plantar pressure distribution between surgical treatment and conservative treatment for CAI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- surgical treatment and conservative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 1 Jun 2020
- 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: From April 1, 2019, information of 20 patients diagnosed with CAI that underwent surgical treatment in our institute and 20 patients that underwent conservative treatment was collected and evaluated.
Who may be able to join
- Patients diagnosed with CAI
- The contralateral ankle joint is healthy
Who cannot join
- Accompanied by other musculoskeletal injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for Chronic Ankle Instability
The objective of this study was to compare the difference of plantar pressure distribution between surgical treatment and conservative treatment for CAI.
Read the detailed description
The data of 20 patients who underwent surgery after reconstruction of the lateral collateral ligament of the ankle joint and 20 patients who underwent balance rehabilitation training were analyzed to compare the clinical effects of surgical treatment and conservative treatment for chronic ankle instability, in order to better guide the selection of the optimal intervention program for patients with chronic ankle joint.
- Conditions
- Chronic Ankle Instability
- Being tested
- surgical treatment, conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatmentProcedure or surgery
Anatomical contraction and termination reconstruction of the lateral ligament
conservative treatmentProcedure or surgery
Rehabilitation intervention training
| Study group | Role | What they receive |
|---|---|---|
| surgical treatment | Patients with CAI undergoing surgical treatment Receives: Procedure: surgical treatment | |
| conservative treatment | Patients with CAI undergoing conservative treatment Receives: Procedure: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAAM
Foot and Ankle Ability Measure Activity
Measured: pre-surgery, one year after sugery
Secondary outcomes (2)
IDFAI
Identification of Functional Ankle Instability questionnaire
Measured: pre-surgery, one year after sugery
Ligament injury by MRI
To evaluate the condition of lateral collateral ligament using magnetic resonance imaging
Measured: pre-surgery, one year after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Apr 2019
- Primary completion1 Apr 2020
- Study completion1 Jun 2020
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 Peking University Third HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuelin Hu, bachelor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961892
- Sponsor's protocol ID
- M2019164
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT04961892
- Acronym / sponsor ID
- M2019164
- Conditions
- Chronic Ankle Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 14 Jul 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 objective of this study was to compare the difference of plantar pressure distribution between surgical treatment and conservative treatment for CAI.
Detailed description
The data of 20 patients who underwent surgery after reconstruction of the lateral collateral ligament of the ankle joint and 20 patients who underwent balance rehabilitation training were analyzed to compare the clinical effects of surgical treatment and conservative treatment for chronic ankle instability, in order to better guide the selection of the optimal intervention program for patients with chronic ankle joint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical treatment | – | Procedure: surgical treatmentPatients with CAI undergoing surgical treatment |
| conservative treatment | – | Procedure: conservative treatmentPatients with CAI undergoing conservative treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From April 1, 2019, information of 20 patients diagnosed with CAI that underwent surgical treatment in our institute and 20 patients that underwent conservative treatment was collected and evaluated.
Key inclusion criteria (2 listed)
- Patients diagnosed with CAI
- The contralateral ankle joint is healthy
Key exclusion criteria (1 listed)
- Accompanied by other musculoskeletal injuries
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 |
|---|---|---|
| surgical treatmentAnatomical contraction and termination reconstruction of the lateral ligament | Procedure or surgery | surgical treatment |
| conservative treatmentRehabilitation intervention training | Procedure or surgery | conservative treatment |
Primary outcome
FAAM
Time frame: pre-surgery, one year after sugery
Foot and Ankle Ability Measure Activity
2 secondary outcomes
IDFAI
Time frame: pre-surgery, one year after sugery
Ligament injury by MRI
Time frame: pre-surgery, one year after sugery
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 14 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Yuelin Hu, bachelor study chair
Peking University Third Hospital
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 Chronic Ankle Instability, run by Peking University Third Hospital at 1 site in China.
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 1 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 14 Jul 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 China. 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?
FAAM (time frame: pre-surgery, one year after sugery). 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 14 Jul 2021.