NCT04027231

Brief Summary

Biomedical implant metals are reactive when in contact with body fluids. Some reactions may adverse the biocompatibility character of the material and should be studied. This can be achieved by direct measurement through electrochemical, gravimetric, spectrophotometric and surface analysis of reaction occurring at the interface between functionalized metal samples and body fluids (synovia) directly extracted from patients. The general aim of this project is to contribute to develop a comprehensive vision of interfacial reactions occurring on biomedical alloy surfaces exposed to human synovial fluid and to link them to clinical data

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 24, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 30, 2025

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

May 24, 2019

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Open circuit potential

    through a potentiostat device

    only 1 measurement immediatly after collection, the day of collection (1 day)

  • Changes in Corrosion speed

    through polarisation resistance

    only 1 serie of measurements immediatly after collection, every 10 minutes, during 1 day

  • Changes in electrochemical impedance spectrum

    through electrochemical impedance spectroscopy

    only one serie of measurements after collection, every 60 minutes, during 1 day

Study Arms (5)

Ahlback I

Other: analysis of the synovial fluid

Ahlback II

Other: analysis of the synovial fluid

Ahlback III

Other: analysis of the synovial fluid

1 year following TKA

Other: analysis of the synovial fluid

TKA revision

Other: analysis of the synovial fluid

Interventions

Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed

1 year following TKAAhlback IAhlback IIAhlback IIITKA revision

Eligibility Criteria

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

Human adults presenting either a knee osteoarthritis, a knee joint replacement at 1-year follow-up or an indication for TKA revision surgery

You may qualify if:

  • indication to knee joint puncture
  • Written consent

You may not qualify if:

  • refusing to sign written consent
  • patient unabled to have a follow-up by their own surgeon/doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV - Site HO

Lausanne, CH, 1011, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 24, 2019

First Posted

July 19, 2019

Study Start

October 15, 2019

Primary Completion

October 30, 2023

Study Completion

December 31, 2024

Last Updated

March 30, 2025

Record last verified: 2024-12

Locations