Osteochondritis DissecansNCT04297449
Prospective 2-year Data Collection of the First 10 Patients After Ankle Spacer Implantation
An observational study of Osteochondritis Dissecans, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteochondritis Dissecans
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2019to 3 Sep 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The average age is 41.7 years (20 - 70 years). Patients with multiple and/or large talar osteochondral defects (OCD) and patients with failed previous surgical treatment for OCD or osteoarthritis of the talus with up to grade two (Kellgren-Lawrence-Score) osteoarthritis on the tibial site are included.
Who may be able to join
- Women and men aged 18-80 years
- Indication for implantation of the ankle spacer
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
Hanover, Lower Saxony, 30625
About this study
Official title: Prospective 2-year Data Collection of the First 10 Patients After Ankle Spacer
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.
Read the detailed description
One surgeon in the investigator's center implanted 10 Ankle Spacers between April 2018 and October 2020. The average age was 41.7 years (20 - 70 years). All patients get a standard followed-up at 6 weeks, 12 weeks. After the first four patients, all following patients are enrolled in a prospective study and where followed up after 1 and 2 years additionally. The American Orthopaedic Foot and Ankle Society (AOFAS) Score, the Foot and Ankle Outcome Score (FAOS), the European Foot and Ankle Score (EFAS), the Visual Analogue Scale (VAS) for pain are collected. Radiographic parameters such as implant loosening, cystic changes, lateral/medial prominence of the implant, congruency to the talar rounding, progression of osteoarthritis or bone ware of the tibia plafond are recorded. The Ankle Spacer is a one-piece implant system that replaces the articulating upper talus surface of the tibio-talar joint, and offers several implant sizes in order to fit to the different talus sizes. It is anatomically designed to the native upper talus surface to provide an optimal fit to the distal articular surface. It has a rough titanium plasma spray (TPS) coated under surface with two posts and spikes for implant fixation. The rough surface enables secondary fixation by means of bone ingrowth and the spikes at the posterior part of the prosthesis allowing for optimal adherence of the implant and for minimal iatrogenic damage upon fixation. By these means, the anatomical situation and the natural congruency of the ankle joint are mirrored to an optimal extent.
- Conditions
- Osteochondritis Dissecans
- Keywords
- Osteochondral defects (OCD) of the talus, Ankle Spacer, osteoarthritis of the ankle joint
- Medical subject headings
- Osteochondritis Dissecans
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective 2-year Data Collection of the First 10 Patients after Ankle Spacer Implantation
Prospective 2-year Data Collection of the First 10 Patients after Ankle Spacer Implantation
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start18 Jan 2019
- Primary completion19 Jan 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondritis DissecansStudies 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
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Lerch, PD Dr., Principal investigator, Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297449
- Sponsor's protocol ID
- 8198_MPG_23b_2018
- Status last verified
- Sep 2021
- First submitted
- 2 Mar 2020
- Last updated
- 16 Sep 2021
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective 2-year Data Collection of the First 10 Patients After Ankle Spacer
- ClinicalTrials.gov ID
- NCT04297449
- Acronym / sponsor ID
- 8198_MPG_23b_2018
- Conditions
- Osteochondritis Dissecans
- Keywords
- Osteochondral defects (OCD) of the talus, Ankle Spacer, osteoarthritis of the ankle joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 5 Mar 2020 (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.
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.
Detailed description
One surgeon in the investigator's center implanted 10 Ankle Spacers between April 2018 and October 2020. The average age was 41.7 years (20 - 70 years). All patients get a standard followed-up at 6 weeks, 12 weeks. After the first four patients, all following patients are enrolled in a prospective study and where followed up after 1 and 2 years additionally. The American Orthopaedic Foot and Ankle Society (AOFAS) Score, the Foot and Ankle Outcome Score (FAOS), the European Foot and Ankle Score (EFAS), the Visual Analogue Scale (VAS) for pain are collected. Radiographic parameters such as implant loosening, cystic changes, lateral/medial prominence of the implant, congruency to the talar rounding, progression of osteoarthritis or bone ware of the tibia plafond are recorded. The Ankle Spacer is a one-piece implant system that replaces the articulating upper talus surface of the tibio-talar joint, and offers several implant sizes in order to fit to the different talus sizes. It is anatomically designed to the native upper talus surface to provide an optimal fit to the distal articular surface. It has a rough titanium plasma spray (TPS) coated under surface with two posts and spikes for implant fixation. The rough surface enables secondary fixation by means of bone ingrowth and the spikes at the posterior part of the prosthesis allowing for optimal adherence of the implant and for minimal iatrogenic damage upon fixation. By these means, the anatomical situation and the natural congruency of the ankle joint are mirrored to an optimal extent.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The average age is 41.7 years (20 - 70 years). Patients with multiple and/or large talar osteochondral defects (OCD) and patients with failed previous surgical treatment for OCD or osteoarthritis of the talus with up to grade two (Kellgren-Lawrence-Score) osteoarthritis on the tibial site are included.
Key inclusion criteria (2 listed)
- Women and men aged 18-80 years
- Indication for implantation of the ankle spacer
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prospective 2-year Data Collection of the First 10 Patients after Ankle Spacer Implantation
Time frame: 2 Years
Prospective 2-year Data Collection of the First 10 Patients after Ankle Spacer Implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
Matthias Lerch, PD Dr. principal investigator
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteochondritis Dissecans, run by Hannover Medical School at 1 site in Germany.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective 2-year Data Collection of the First 10 Patients after Ankle Spacer Implantation (time frame: 2 Years). 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 16 Sep 2021.