Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

NCT ID: NCT05980442

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-03

Study Completion Date

2026-12-31

Brief Summary

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Randomized, controlled, single center observational study to compare the safety and performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee arthroplasty (TKA). The aim of the study is the comparison of the clinical outcome between navigated and robotic-assisted TKA. The hypothesis of the study is that both treatments achieve similar results regarding functional and clinical aspects.

Detailed Description

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Conditions

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Osteoarthritis, Knee Joint Diseases Rheumatoid Arthritis of Knee Posttraumatic Arthropathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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OrthoPilot® Elite

navigated / computer assisted total knee replacement surgery

Navigated total knee arthroplasty

Intervention Type DEVICE

Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system

MAKO

robot assisted total knee replacement surgery

Robot assisted total knee arthroplasty

Intervention Type DEVICE

Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system

Interventions

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Navigated total knee arthroplasty

Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system

Intervention Type DEVICE

Robot assisted total knee arthroplasty

Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system

Intervention Type DEVICE

Other Intervention Names

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Columbus® total knee endoprosthesis Triathlon® total knee endoprosthesis

Eligibility Criteria

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Inclusion Criteria

* Indication for a TKA with a fixed-bearing total knee endoprosthesis
* Written informed consent for participating in the clinical study

Exclusion Criteria

* Patient age \<18 years and \>90 years
* Patient not willing to participate at the follow-up
* Pregnancy
* retropatellar arthrosis requiring patella resurfacing
* American Society of Anaesthesiologists (ASA) Classification \>3
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans-Joachim Riesner, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Bundeswehr Krankenhaus Ulm

Locations

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Bundeswehr Krankenhaus Ulm

Ulm, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Kristin Maier, Dr.

Role: CONTACT

+49746195

Marius Selig

Role: CONTACT

+49746195

Facility Contacts

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Hans-Joachim Riesner, PD Dr. med.

Role: primary

Jörg Schneider, Dr. med.

Role: backup

Other Identifiers

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AAG-O-H-23032

Identifier Type: -

Identifier Source: org_study_id

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