CompletedNot Applicable

Prospective 2-year Data Collection of the First 10 Patients After Ankle Spacer Implantation

Germany8 participantsStarted 2019-01-18

Plain-language summary

Osteochondral defects (OCD) of the talus are pathologic lesions of the talar cartilage and its subchondral bone and might severely deteriorate the quality of life. For the treatment of multiple and/or large talar OCDs and in patients with failed previous surgical treatment the Ankle Spacer was developed. Six patients are included in a prospective clinical and radiological study with a follow-up of two years.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women and men aged 18-80 years * Indication for implantation of the ankle spacer Exclusion Criteria: * Florid infections * Relevant circulatory disorders on the affected leg * Malposition of the OSG (upper ankle Joint) greater than 5 ° varus or valgus * Fractures of the OSG or near the ankle that were less than 6 months ago * Obesity with a BMI greater than 30 kg / m2 * Known insulin-dependent diabetes mellitus * Known rheumatoid Arthritis * Osteoarthritis of the OSG II ° or higher according to Kellgren / Lawrence * Deformation of the OSG, which does not allow implantation of the ankle spacer

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prospective 2-year Data Collection of the First 10 Patients after Ankle Spacer Implantation

Timeframe: 2 Years

Trial details

NCT IDNCT04297449

SponsorHannover Medical School

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-01-19

View on ClinicalTrials.gov More Osteochondritis Dissecans trials