Osteochondral Lesion of TalusNCT05476692
Clinical Outcome of Surgical Treatment for Osteochondral Lesions of the Talus
An observational study of Osteochondral Lesion of Talus, run by Assiut University.
Trial summary
Assess clinical and radiological outcome of the various surgical techniques for treatment of osteochondral lesions of the talus Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Osteochondral Lesion of Talus
- What is being tested?
- AOFAS score and VAS
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Nov 2023
- 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 15 to 60 years
- All sexes
- Child, Adult
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
Who may be able to join
- Age from 15 to 60 years old.
- Traumatic and degenerative etiology.
- without ankle deformity.
- No inflammatory arthritis.
- Absent or corrected ligamentous instability
Who cannot join
- Older than 60 years old and younger than 15 years old.
- Charcot ankle.
- Vascular injury.
Trial locations and contacts
No sites are listed yet.
About this study
Assess clinical and radiological outcome of the various surgical techniques for treatment of osteochondral lesions of the talus
Read the 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 .
- Conditions
- Osteochondral Lesion of Talus
- Being tested
- AOFAS score and VAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOFAS score and VASOther
Clinical outcome by the Visual analogue scale (VAS) and the American Orthopaedic Foot and Ankle (AOFAS) score.
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcome of the various surgical techniques for treatment of osteochondral lesions of the talus
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Lesion of TalusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Magdy Fahmy Dawood, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476692
- Sponsor's protocol ID
- OCD of the talus
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Surgical Treatment for Osteochondral Lesions of the Talus
- ClinicalTrials.gov ID
- NCT05476692
- Acronym / sponsor ID
- OCD of the talus
- Conditions
- Osteochondral Lesion of Talus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 27 Jul 2022 (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.
Assess clinical and radiological outcome of the various surgical techniques for treatment of osteochondral lesions of the talus
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Key inclusion criteria (5 listed)
- Age from 15 to 60 years old.
- Traumatic and degenerative etiology.
- without ankle deformity.
- No inflammatory arthritis.
- Absent or corrected ligamentous instability
Key exclusion criteria (3 listed)
- Older than 60 years old and younger than 15 years old.
- Charcot ankle.
- Vascular injury.
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 |
|---|---|---|
| AOFAS score and VASClinical outcome by the Visual analogue scale (VAS) and the American Orthopaedic Foot and Ankle (AOFAS) score. | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Management of Osteochondral Lesions of the Talar DomeLink provided by the sponsor.
- Osteochondritis dissecans of the talusLink provided by the sponsor.
- Long-term Outcomes of Microfracture for Treatment of Osteochondral Lesions of the TalusLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteochondral Lesion of Talus, run by Assiut University.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mena Magdy (01272640608, menamagdy2353794@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical outcome of the various surgical techniques for treatment of osteochondral lesions of the talus (time frame: 1 year). 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 27 Jul 2022.