Survival Study of the Genutech® Total Knee Arthroplasty

Hospital de Sant Rafael

Status: Enrolling

Conditions: Knee Osteoarthritis

Study type: Observational

Funder types: Other

Identifiers

NCT06899932

PR-2021-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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