NCT05509972

Brief Summary

This clinical study is a Post-Market Clinical Follow-Up (PMCF) measure and is aiming to compare the in-vivo wear behaviour of the Columbus® total knee prosthesis between the standard Cobalt Chromium (CoCr) and the multilayer coated so called "Advanced Surface" (AS) of the same implant. The clinical investigation is designed as a International, prospective, longterm non-interventional study in order to gain clinical data of many patients within the routine clinical application of the investigational device.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 11, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

April 6, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

August 11, 2022

Last Update Submit

October 7, 2024

Conditions

Knee ArthritisKnee OsteoarthritisPrimary Osteoarthritis of Knee NosSecondary Osteoarthritis of Knee NosRheumatoid Arthritis of KneeInstability, JointOsteonecrosisDeformity Knee

Keywords

Total Knee ArthroplastyImplant WearAdvanced Surface

Outcome Measures

Primary Outcomes (1)

  • Polyethylene wear over time

    The in-vivo wear of the Polyethylene (PE) tibial tray will be assessed using the observer independent method of the imaging core lab. The PE wear assessment is based on the absolute object position of the knee prosthesis over time.

    until 10 years postoperatively

Secondary Outcomes (11)

  • Implant survival

    until 10 years postoperatively

  • Quality of Life [EQ-5D-5L] compared to baseline

    preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively

  • Progress of Clinical Outcome (Forgotten Joint Score-12) over follow-up period

    3 months, 12 months, 2 years, 5 years, 10 years postoperatively

  • Progress of Clinical Outcome [Oxford Knee Score] compared to baseline

    preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively

  • Radiographic comparison of alignment over time

    baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years

  • +6 more secondary outcomes

Other Outcomes (4)

  • Baseline data

    preoperatively

  • Implant specifications

    intraoperatively

  • Surgery time

    intraoperatively

  • +1 more other outcomes

Study Arms (2)

Columbus® DD Primary CoCr

Columbus® Deep Dish (DD) Primary Cobalt Chromium (CoCr)

Device: total knee prosthesis implantation

Columbus® DD Primary CoCr AS coated

Columbus® Deep Dish (DD) Primary Cobalt Chromium (CoCr) Advanced Surface

Device: total knee prosthesis implantation

Interventions

total knee prosthesis implantationDEVICE

Total Knee Arthroplasty (TKA) represents a well-established, reliable and successful treatment option for end-stage bicompartmental osteoarthritis or comparable conditions even in young patients compromised by knee pain and limitations of daily living

Also known as: Columbus® Total Knee Arthroplasty
Columbus® DD Primary CoCrColumbus® DD Primary CoCr AS coated

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited consecutively.

You may qualify if:

  • Indication for a primary bicondylar total knee endoprosthesis with the Columbus® DD knee prosthesis
  • Written signed informed consent of patient
  • Willingness and mental ability to participate at the long-term follow-up examinations

You may not qualify if:

  • Pregnancy
  • Patient age \<45 and \>75years
  • Acute inflammatory arthritis
  • Coagulation disorders (e.g. Haemophilia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, KneeJoint InstabilityOsteonecrosis

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 22, 2022

Study Start

April 6, 2023

Primary Completion

February 1, 2024

Study Completion

August 30, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations

DE(1)