- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07335133
Postoperative Complications of Ankle Arthroscopy (ARTHRO2025)
Short- and Medium-term Postoperative Complications of Ankle Arthroscopy
The goal of this clinical trial is to describe complications that occurred in the year following surgery, based on follow-up surgical consultations and physical therapy sessions.
The target population is any adult patient who has undergone ankle surgery performed under arthroscopy.
Primary outcome is description of all complications occurring within one year following ankle arthroscopy. This description will be based on clinical and functional examinations performed by surgeons and physical therapists.
Participants will be regularly monitored by the surgeon and physical therapist (15 days postoperative, 3 months, 6 months, and 1 year).
They will complete self-assessment questionnaires and undergo functional physical therapy tests, including ALR RSI, FAAM AVQ, FAAM Sport, CAIT, and Ankle Go.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34430
- Recruiting
- Clinique St jean sud de france
-
Contact:
- Cecile Spirito
- Phone Number: 00304 67 41 34 53
- Email: cecile.spirito@capsante.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patient who has been informed and has signed the consent form
- Patient scheduled for arthroscopic ankle surgery.
- Patient affiliated with or covered by a health insurance plan
Exclusion Criteria:
- Recent traumatic injury (less than 1 month old), physical therapy assessment impossible
- Inability to follow up for up to one year
- Patient under legal protection
- Pregnant woman, patient under guardianship or conservatorship
- Patient who has already undergone ankle surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Cohort of patients who underwent ankle arthroscopy
|
Additional physical therapy and surgery tests and scores are performed on patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications occurring within one year following ankle arthroscopy
Time Frame: One year
|
Description of all complications occurring within one year following ankle arthroscopy.
This description will be based on clinical and functional examinations performed by surgeons and physical therapists.
|
One year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A02186-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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