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Search / Trial NCT03817632

Orthopilot Elite Post-Market Clinical Follow-Up

Launched by AESCULAP AG · Jan 23, 2019

Trial Information

Current as of May 17, 2025

Completed

Keywords

Navigation Computer Assisted Orthopedic Surgery Ortho Pilot® Total Knee Arthroplasty

ClinConnect Summary

The study is designed as a prospective, non-interventional, multicenter, comparative cohort study. The product under investigation will be used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).

The study design is based on a two-arms design. The patients for the both groups will be recruited consecutively, starting with group A. The study will prove the equivalence of the groups regarding the outcome of the postoperative lower limb alignment (mechani...

Gender

ALL

Eligibility criteria

  • Inclusion: Inclusion Criteria:
  • Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot® navigation system and a corresponding primary implant
  • Dated and signed informed consent
  • Exclusion: Exclusion Criteria
  • Pregnancy
  • Patients \< 18 years
  • Patients unable to participate at the follow-up examination (physically, mentally)
  • Previous joint replacement at the indexed knee

About Aesculap Ag

Aesculap AG is a prominent global medical device manufacturer specializing in surgical instruments, implants, and innovative healthcare solutions. With a rich history rooted in excellence and innovation, Aesculap AG is dedicated to advancing surgical practices through cutting-edge technology and a commitment to improving patient outcomes. The company collaborates with healthcare professionals and institutions to conduct clinical trials that evaluate the safety and efficacy of its products, ensuring that they meet the highest standards of quality and performance. Through its rigorous research and development initiatives, Aesculap AG aims to contribute significantly to the field of medicine and enhance the standards of surgical care worldwide.

Locations

Dresden, , Germany

Freiburg, , Germany

Hamburg, , Germany

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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