- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05476692
Clinical Outcome of Surgical Treatment for Osteochondral Lesions of the Talus
July 26, 2022 updated by: Mena Magdy Fahmy Dawood, Assiut University
Assess clinical and radiological outcome of the various surgical techniques for treatment of osteochondral lesions of the talus
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Osteochondritis dissecans (OCD) of the talus is a subchondral bone pathology that presents as an osteochondral lesion of the talar dome with consequent articular cartilage abnormalities.
Osteochondral lesions of the talus (OLT) are frequent after acute ankle trauma.
The natural history of the OLT remains unclear due to paucity of longitudinal follow-up studies.
Various treatment strategies have been described for OLT, including conservative treatment and operative treatment However, the current literature does not allow firm evidence-based recommendations concerning the treatment to be established ; Microfracture is the most common reparative surgery for osteochondral lesions of the talus (OLTs).
While shown to be effective in short- to midterm outcomes, the fibrocartilage that microfracture produces is both biomechanically and biologically inferior to that of native hyaline cartilage and is susceptible to possible deterioration over time following repair .
Arthroscopic debridement (AD) for the osteochondral lesions of the talar dome (OLT) was widely documented in the nineties with satisfactory results.
However, in modern treatment algorithms, its role is not described.
A frequently used instrument for assessing outcome after ankle and hindfoot injuries is the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score .
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mena Magdy
- Phone Number: 01272640608
- Email: menamagdy2353794@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
the study is a descriptive case series study.
The sample will be included from the admitted 40 patients during 12 months from the start of the study
Description
Inclusion Criteria:
- Age from 15 to 60 years old.
- Traumatic and degenerative etiology.
- without ankle deformity.
- No inflammatory arthritis.
- Absent or corrected ligamentous instability
Exclusion Criteria:
- Older than 60 years old and younger than 15 years old.
- Charcot ankle.
- Vascular injury.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical outcome of the various surgical techniques for treatment of osteochondral lesions of the talus
Time Frame: 1 year
|
clinical outcome of the various surgical techniques for treatment of osteochondral lesions of the talus , Clinical outcome by the AOFAS score ( American Orthopaedic Foot and Ankle Society), the higher score means the better outcome and the lower score means the worse outcome
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2022
Primary Completion (Anticipated)
October 1, 2023
Study Completion (Anticipated)
November 1, 2023
Study Registration Dates
First Submitted
July 18, 2022
First Submitted That Met QC Criteria
July 26, 2022
First Posted (Actual)
July 27, 2022
Study Record Updates
Last Update Posted (Actual)
July 27, 2022
Last Update Submitted That Met QC Criteria
July 26, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- OCD of the talus
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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