Study on the survival of Genutech® total knee implants in patients with knee osteoarthritis
Survival Study of the Genutech® Total Knee Arthroplasty
This study looks at how well Genutech® total knee implants work for people with knee osteoarthritis over time by checking if they need any follow-up surgeries and how they feel about their knee function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital de Sant Rafael Academic / other |
| Locations | 1 site (Barcelona, Barcelona) |
| Trial ID | NCT06899932 on ClinicalTrials.gov |
What this trial studies
This observational study follows a cohort of patients undergoing Genutech® total knee arthroplasty at the Hospital de Sant Rafael in Barcelona. Data will be collected before and after the surgery at one, five, and ten years to evaluate the survival of the knee implant, defined as the absence of revision surgeries. Secondary outcomes include clinical and radiological assessments using the Oxford Knee Score, SF12 questionnaire, and WOMAC index to measure patient-reported outcomes and quality of life. The study aims to provide insights into the long-term effectiveness of this specific knee prosthesis.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with knee osteoarthritis who have not responded to conservative treatments and are undergoing Genutech® total knee arthroplasty.
Not a fit: Patients who have previously undergone total knee arthroplasty in the same joint or are unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable data on the longevity and effectiveness of Genutech® total knee implants, improving treatment options for patients with knee osteoarthritis.
How similar studies have performed: Other studies on total knee arthroplasty have shown success in evaluating implant survival and patient outcomes, indicating that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Barcelona, Barcelona
- Hospital Sant Rafael — Barcelona, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Jordi Faig-Martí, MD, PhD
- Email: jfaigm.hsrafael@hospitalarias.es
- Phone: +34932112508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.