Osteochondral DefectNCT06225674
Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects
An observational study of Osteochondral Defect, run by Episurf Medical Inc. at 6 sites in 2 countries.
Trial summary
This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal osteochondral defects on the talus bone in the ankle. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Osteochondral Defect
- What is being tested?
- Episealer Talus implant
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 6 Nov 2023to 6 Mar 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients previously treated with Episealer Talus implant after January 2020. In total approximately 25 adult subjects, male or female, from 6 clinics (Sweden and Germany) will be included in the investigation.
Who may be able to join
- Signed Informed Consent Form
- Patients ≥ 18 years old at the time of index procedure
- Patients who previously received Episealer Talus implant after January 2020
Who cannot join
- "None"
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites, 4 recruiting
- Recruiting
Robert-Koch-Krankenhaus Apolda
Apolda
Dirk Seifert
- Recruiting
OrthoCentrum Hamburg
Hamburg
Johannes Holz
- Recruiting
St. Elisabeth-Krankenhaus
Salzgitter
Qing Shou
- Recruiting
St. Ansgar Sulingen-Bassum
Sulingen
Jens Peters
Sweden2 sites, 2 recruiting
- Recruiting
Aleris Hand @ Fot
Stockholm
Jouko Kivioja
- Recruiting
FotCenter
Stockholm
Hans Wahlström
About this study
Official title: A Retrospective, Observational, Post-market Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects
This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal osteochondral defects on the talus bone in the ankle. This retrospective investigation aims to collect data from patients with focal osteochondral defects treated with Episealer Talus, to provide insight on the potential benefit of Episealer Talus in the treatment of focal osteochondral defects.
The aim for the clinical investigation is to collect data from approximately 25 adult subjects who were treated for focal osteochondral defect with Episealer Talus implant in 6 clinics (Sweden and Germany) since January 2020, when the devices were CE-marked. The data collected for each subject will include demographics and data generated in relation to the surgery itself and the post-surgery phases including e.g. focal defect grade and position, collected through medical record review. Each subject will also be asked to complete a set of QoL questionnaires (SEFAS, FAOS and VAS).
Read the detailed description
This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal OCDs. The overall clinical investigation is based on the patient's reported outcome (PROs) from OCD patients previously treated with Episealer Talus implant after January 2020. In total approximately 25 adult subjects, male or female, from 6 clinics (Sweden and Germany) will be included in the investigation.
Subjects will be identified by the investigational site team through medical record review and/or site knowing the subjects from performing the implantation after January 2020. Following collection of the subject´s signed informed consent, subject demographics, health- and surgery-related data will be collected from the subjects' medical records. Therefore, only one visit is planned for each subject during the clinical investigation. The performance variables relate to quality of life, and all subjects will be asked to fill in three questionnaires (SEFAS, FAOS and VAS).
The overall duration of the investigation is estimated to be 4 months, including a 1 month recruitment period. Each subject is estimated to spend approximately 1-2 hour for completing the informed consent and completing the questionnaires. Subject´s participation in the clinical investigation will be terminated once the questionnaires have been completed and the site team considers all data collected for the subject.
- Conditions
- Osteochondral Defect
- Being tested
- Episealer Talus implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episealer Talus implantDevice
This is an observational study, no intervention will be done. The aim for the clinical investigation is to collect data from approximately 25 adult subjects who were treated for focal osteochondral defect with Episealer Talus implant in 6 clinics (Sweden and Germany) since January 2020.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of total SEFAS (self-reported foot and ankle score) outcome
SEFAS data will be extracted from the patient´s reported outcome (PROs). Range 0-48, low score is better
Measured: 1 hour
Secondary outcomes (4)
Assessment of total FAOS (Foot and Ankle Outcome Score) and subscale (pain, other symptoms, activities of daily living, sport and recreational function,
FAOS data will be extracted from the patient´s reported outcome (PROs). Range 0-100, low score is better
Measured: 30 minutes
Assessment of total Visual Analogue Scale and subsections (rest, walking running, climb steps)
VAS data will be extracted from the patient´s reported outcome (PROs), Range 0-10, low score is better.
Measured: 10 minutes
Surgery-related information
Retrospective data collection
Measured: 10 minutes
Additional clinical performance parameters of Episealer Talus implant
Subject's and PI's treatment satisfaction (Self reported, scale 1-5 low score is better)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start6 Nov 2023
- Primary completion6 Mar 2024 (estimated)
- Study completion6 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral DefectStudies 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
- Other
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Episurf Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jouko Kivioja, Principal investigator, Aleris Hand @ Fot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225674
- Sponsor's protocol ID
- Epi_002
- Status last verified
- Jan 2024
- First submitted
- 13 Dec 2023
- Last updated
- 26 Jan 2024
- 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 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational, Post-market Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects
- ClinicalTrials.gov ID
- NCT06225674
- Acronym / sponsor ID
- Epi_002
- Conditions
- Osteochondral Defect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Episurf Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 6 Mar 2024 (estimated)
- Study completion
- 6 Mar 2024 (estimated)
- First posted
- 26 Jan 2024 (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.
This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal osteochondral defects on the talus bone in the ankle. This retrospective investigation aims to collect data from patients with focal osteochondral defects treated with Episealer Talus, to provide insight on the potential benefit of Episealer Talus in the treatment of focal osteochondral defects.
The aim for the clinical investigation is to collect data from approximately 25 adult subjects who were treated for focal osteochondral defect with Episealer Talus implant in 6 clinics (Sweden and Germany) since January 2020, when the devices were CE-marked. The data collected for each subject will include demographics and data generated in relation to the surgery itself and the post-surgery phases including e.g. focal defect grade and position, collected through medical record review. Each subject will also be asked to complete a set of QoL questionnaires (SEFAS, FAOS and VAS).
Detailed description
This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal OCDs. The overall clinical investigation is based on the patient's reported outcome (PROs) from OCD patients previously treated with Episealer Talus implant after January 2020. In total approximately 25 adult subjects, male or female, from 6 clinics (Sweden and Germany) will be included in the investigation.
Subjects will be identified by the investigational site team through medical record review and/or site knowing the subjects from performing the implantation after January 2020. Following collection of the subject´s signed informed consent, subject demographics, health- and surgery-related data will be collected from the subjects' medical records. Therefore, only one visit is planned for each subject during the clinical investigation. The performance variables relate to quality of life, and all subjects will be asked to fill in three questionnaires (SEFAS, FAOS and VAS).
The overall duration of the investigation is estimated to be 4 months, including a 1 month recruitment period. Each subject is estimated to spend approximately 1-2 hour for completing the informed consent and completing the questionnaires. Subject´s participation in the clinical investigation will be terminated once the questionnaires have been completed and the site team considers all data collected for the subject.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients previously treated with Episealer Talus implant after January 2020. In total approximately 25 adult subjects, male or female, from 6 clinics (Sweden and Germany) will be included in the investigation.
Key inclusion criteria (3 listed)
- Signed Informed Consent Form
- Patients ≥ 18 years old at the time of index procedure
- Patients who previously received Episealer Talus implant after January 2020
Key exclusion criteria (1 listed)
- "None"
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 |
|---|---|---|
| Episealer Talus implantThis is an observational study, no intervention will be done. The aim for the clinical investigation is to collect data from approximately 25 adult subjects who were treated for focal osteochondral defect with Episealer Talus implant in 6 clinics (Sweden and Germany) since January 2020. | Device | – |
Primary outcome
Assessment of total SEFAS (self-reported foot and ankle score) outcome
Time frame: 1 hour
SEFAS data will be extracted from the patient´s reported outcome (PROs). Range 0-48, low score is better
4 secondary outcomes
Assessment of total FAOS (Foot and Ankle Outcome Score) and subscale (pain, other symptoms, activities of daily living, sport and recreational function,
Time frame: 30 minutes
Assessment of total Visual Analogue Scale and subsections (rest, walking running, climb steps)
Time frame: 10 minutes
Surgery-related information
Time frame: 10 minutes
Additional clinical performance parameters of Episealer Talus implant
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
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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.
Jouko Kivioja principal investigator
Aleris Hand @ Fot
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteochondral Defect, run by Episurf Medical Inc. at 6 sites in 2 countries.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fredrik Zetterberg (+46 70-839 62 33, fredrik.zetterberg@episurf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of total SEFAS (self-reported foot and ankle score) outcome (time frame: 1 hour). 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 26 Jan 2024.