Survival Study of the Genutech® Total Knee Arthroplasty

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06899932

Enrollment

500

Registered

2025-03-28

Start date

2021-01-01

Completion date

2033-01-01

Last updated

2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Total Knee Arthroplasty, Knee Osteoarthritis

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients without revision surgery	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

Measure	Time frame	Description
Oxford Knee Score	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.
SF12 questionnaire	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.
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire	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.

Countries

Spain

Contacts

Primary ContactJordi Faig-Martí, MD, PhD

jfaigm.hsrafael@hospitalarias.es+34932112508

Outcome results