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

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ClinicalTrials.gov Identifier: NCT04297449
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Hannover Medical School

Brief 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.

Condition or disease
Osteochondritis Dissecans

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.

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Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective 2-year Data Collection of the First 10 Patients After Ankle Spacer
Actual Study Start Date : January 18, 2019
Estimated Primary Completion Date : January 18, 2021
Estimated Study Completion Date : March 18, 2023





Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297449


Contacts
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Contact: Matthias Lerch, PD Dr. +49 511 5354 576 matthias.lerch@diakovere.de
Contact: Deiwei Yao, Dr. +49 511 5354 521 deiwei.yao@diakovere.de

Locations
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Germany
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift Recruiting
Hanover, Niedersachsen, Germany, 30625
Contact: Matthias Lerch, PD Dr.    +49 511 5354 576    matthias.lerch@diakovere.de   
Contact: Daiwei Yao, Dr.    +49 511 5354 521    daiwei.yao@diakovere.de   
Sponsors and Collaborators
Hannover Medical School
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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT04297449    
Other Study ID Numbers: 8198_MPG_23b_2018
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hannover Medical School:
Osteochondral defects (OCD) of the talus
Ankle Spacer
osteoarthritis of the ankle joint
Additional relevant MeSH terms:
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Osteochondritis
Osteochondritis Dissecans
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases