NCT05980442

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jul 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jul 2024Dec 2028

First Submitted

Initial submission to the registry

July 19, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

July 3, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

July 19, 2023

Last Update Submit

March 26, 2026

Conditions

Osteoarthritis, KneeRheumatoid Arthritis of KneePosttraumatic ArthropathyJoint Diseases

Keywords

computer assisted orthopedic surgeryrobotic assisted orthopedic surgeryorthopedic navigationtotal knee arthroplastytotal knee replacement

Outcome Measures

Primary Outcomes (1)

  • Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component)

    Functional result one year postoperatively measured with the functional component of the Knee Society Score (KSS). The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA. It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.

    one year postoperatively

Secondary Outcomes (7)

  • Survival of the implant components

    one year postoperatively

  • Clinical outcome of the Knee Surgery measured by the Knee Society Score (KSS) (clinical component)

    one year postoperatively

  • Quality of Life [EQ-5D-5L]

    one year postoperatively

  • Anterior knee pain

    one year postoperatively

  • Comparison of Radiographic alignment

    one year postoperatively

  • +2 more secondary outcomes

Study Arms (2)

OrthoPilot® Elite

navigated / computer assisted total knee replacement surgery

Device: Navigated total knee arthroplasty

MAKO

robot assisted total knee replacement surgery

Device: Robot assisted total knee arthroplasty

Interventions

Navigated total knee arthroplastyDEVICE

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

Also known as: Columbus® total knee endoprosthesis
OrthoPilot® Elite
Robot assisted total knee arthroplastyDEVICE

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

Also known as: Triathlon® total knee endoprosthesis
MAKO

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients between 18 and 90 years of age having indication for a fixed-bearing total knee endoprosthesis, without retropatellar arthrosis requiring patella resurfacing

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundeswehr Krankenhaus Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeJoint Diseases

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Hans-Joachim Riesner, PD Dr. med.

    Bundeswehr Krankenhaus Ulm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Maier, Dr.

CONTACT

+49746195info@aesculap.de

Marius Selig

CONTACT

+49746195info@aesculap.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 8, 2023

Study Start

July 3, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)