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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Hanover, Niedersachsen, Germany, 30625
      • Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 Years

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Matthias Lerch, PD Dr., Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): January 19, 2021
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Osteochondral defects (OCD) of the talus; Ankle Spacer; osteoarthritis of the ankle joint
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Cartilage Diseases; Osteochondritis; Osteochondritis Dissecans
• Other Study ID Numbers: 8198_MPG_23b_2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No