Survival Study of the Genutech® Total Knee Arthroplasty | NCT06899932

Studies
Survival Study of the Genutech® Total Knee Arthroplasty

NCT06899932

Sponsor

Hospital de Sant Rafael

Status

Recruiting

Last Update Posted

Mar 28, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Knee Osteoarthritis

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jan 1, 2032Estimated

Completion Date

Jan 1, 2033Estimated

First Submitted Date

Mar 11, 2025

First Submission Date that Met QC Criteria

Mar 27, 2025

First Posted Date

Mar 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2025

Last Update Posted Date

Mar 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients without revision surgery	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.	5 and 10 years

Secondary Outcomes

Measure	Description	Time Frame
Oxford Knee Score	Clinical evaluation with Patient Reported Outome Measures (PROMs): Oxford Knee Score (OKS). OKS score is higher with good results and lower with bad results.	one, 5 and 10 years
SF12 questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients referred to the investigators' Institution by Primary Care centres to receive Orthopaedic care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jordi Faig-Martí, MD, PhD	Contact	+34932112508		jfaigm.hsrafael@hospitalarias.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Sant Rafael	Recruiting	Barcelona	Barcelona	08035	Spain

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided