Hospital Sant Rafael
Barcelona, 08035, Spain
Location status: Recruiting
NCT Number: NCT06899932
Prospective cohort sudy of patients undergoing a Genutech® total knee arthroplasty
Interested in participating?
Request Info18 year and older
All sexes
Observational
Barcelona, 08035, Spain
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Hospital de Sant Rafael
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT05495334
Arthritis, Joint Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT07721116
Arthritis, Artificial Intelligence
Taipei, Taiwan
View Trial DetailsNCT06507046
Arthritis, Joint Diseases
Kristiansund, Møre and Romsdal, Norway
View Trial DetailsNCT07484594
Arthritis, Joint Diseases
Islamabad, AL, Pakistan
View Trial Details