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

NCT04297449 | Completed

• 1 other identifier: 8198_MPG_23b_2018
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteochondritis Dissecans

Keywords

Osteochondral defects (OCD) of the talus; Ankle Spacer; osteoarthritis of the ankle joint

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Women and men aged 18-80 years
• Indication for implantation of the ankle spacer

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Osteochondritis Dissecans

Condition Hierarchy (Ancestors)

Osteochondritis; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Matthias Lerch, PD Dr.

  Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: January 18, 2019
• Primary Completion: January 19, 2021
• Study Completion: September 3, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

DE (1)