NCT06899932

Brief Summary

Prospective cohort sudy of patients undergoing a Genutech® total knee arthroplasty

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Jan 2021

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 Progress45%
Jan 2021Jan 2033

Study Start

First participant enrolled

January 1, 2021

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2032

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2033

Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

11 years

First QC Date

March 11, 2025

Last Update Submit

March 27, 2025

Conditions

Knee Osteoarthritis

Keywords

Total Knee ArthroplastyKnee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Number of patients without revision surgery

    the main goal is to determine the implant survival, that is, having no revision during follow-up. The number of patients requiring revision will be compared to the total of patients included in the study.

    5 and 10 years

Secondary Outcomes (3)

  • Oxford Knee Score

    one, 5 and 10 years

  • SF12 questionnaire

    1, 5 and 10 years postoperatively

  • WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire

    One, 5 and 10 years

Eligibility Criteria

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

Patients referred to the investigators' Institution by Primary Care centres to receive Orthopaedic care

You may qualify if:

  • Patients older than 18 years with knee osteoarthritis that had not responded to conservative treatment
  • capable of providing informed consent
  • patients who receive a Genutech® total knee prosthesis at the investigators' Institution.

You may not qualify if:

  • having received a prior total knee arthroplasty in the same joint
  • inability to provide informed consent
  • not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sant Rafael

Barcelona, Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Jordi Faig-Martí, MD, PhD

CONTACT

+34932112508jfaigm.hsrafael@hospitalarias.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 28, 2025

Study Start

January 1, 2021

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

January 1, 2033

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

ES(1)