Survival Study of the Genutech® Total Knee Arthroplasty

NCT ID: NCT06899932

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2033-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Sant Rafael

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Sant Rafael

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jordi Faig-Martí, MD, PhD

Role: CONTACT

+34932112508

Facility Contacts

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Jordi Faig-Martí, MD, PhD

Role: primary

+34932112508

Other Identifiers

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PR-2021-01

Identifier Type: -

Identifier Source: org_study_id

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