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Recruiting

NCT Number: NCT06899932

Survival Study of the Genutech® Total Knee Arthroplasty

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sant Rafael

Barcelona, 08035, Spain

Location status: Recruiting

Location contact

Jordi Faig-Martí, MD, PhD

CONTACT

[email protected]

+34932112508

About this study

A prospective cohort study will be performed collecting patient's data before and after the total knee arthroplasty surgical procedure at one, five and ten years. The main goal of this work is to prospectively study the results obtained with the implantation of the knee prosthesis currently used in the Orthopaedic Service of Sant Rafael Hospital of Barcelona (Genutech®). The main outcome of the study is the survival of the implant, that is, having no revision surgeries in the follow-up. The secondary objective is the clinical and radiological evaluation of the implants measured by outcome measueres: Oxford Knee Score (OKS), SF12 questionnaire and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire. OKS and SF12 scores are higher with good results and lower with bad results. WOMAC expresses results the other way around.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of patients without revision surgery

    Time frame: 5 and 10 years

    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.

Secondary outcomes

  1. Oxford Knee Score

    Time frame: one, 5 and 10 years

    Clinical evaluation with Patient Reported Outome Measures (PROMs): Oxford Knee Score (OKS). OKS score is higher with good results and lower with bad results.

  2. SF12 questionnaire

    Time frame: 1, 5 and 10 years postoperatively

    Clinical evaluation with Patient Reported Outome Measures (PROMs): SF12 questionnaire. SF12 scores are higher with good results and lower with bad results.

  3. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire

    Time frame: One, 5 and 10 years

    Clinical evaluation with Patient Reported Outome Measures (PROMs): WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire. WOMAC scores are higher with bad results and lower with good results.

Study contacts

Contact information is provided by the study sponsor or research team.

Jordi Faig-Martí, MD, PhD

CONTACT

[email protected]

+34932112508

Sponsors and collaborators

Lead sponsor

Hospital de Sant Rafael

Other

Registry information

Important dates

Study start
2021
Primary completion
2032
Study completion
2033
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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