NCT04858347

Brief Summary

This is a prospective, multicenter, observational study with a planned follow-up period of 10 years to confirm the safety and performance of the GEMINI SL Fixed Bearing PS knee prosthesis in longterm follow-up under routine conditions. Primary outcome of the study is the 10-year survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis with revision for any reason as the endpoint.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
115mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jul 2019Oct 2035

Study Start

First participant enrolled

July 4, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2034

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2035

Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

15.3 years

First QC Date

April 14, 2021

Last Update Submit

January 11, 2023

Conditions

Osteoarthrosis of Knee

Outcome Measures

Primary Outcomes (1)

  • 10-year survival rate of the Gemini SL Fixed Bearing PS knee prothesis

    Primary outcome of the study is the 10-year survival rate of the Gemini SL Fixed Bearing PS knee prosthesis with revision for any reason as the endpoint. Revisions are defined as removal, exchange or adding of any implant components. The definition does not include subsequent implantations or exchange of the patella component or the polyethylene plateau. Survival rate will be calculated according to the method of Kaplan-Meier.

    10 years

Secondary Outcomes (5)

  • Survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis

    after 6 months, 1,3 and 5 years

  • Change in functional and clinical outcome (KOOS)

    preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years

  • Change in functional and clinical outcome (KSS)

    preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years

  • Complications rate

    Intraoperative examinations to 10-year follow-up examination

  • Subsequent surgical interventions

    postoperative examinations up to 10-year follow-up examination

Interventions

Total knee replacementDEVICE

Implantation of the GEMINI SL Fixed Bearing PS knee prosthesis. The operation technique of the GEMINI SL Fixed Bearing PS knee prosthesis will be followed.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who are scheduled for an implantation of the GEMINI SL Fixed Bearing PS knee prosthesis are potential study participants. The decision about the surgical treatment and the use of the GEMINI SL Fixed Bearing PS knee prosthesis is made by the treating surgeons and depends on Link Gemini SL Fixed Bearing PS \_ Colombia Version 1.0 vom 24.08.2018 Seite 12 von 19 the clinical findings of the patient. The potential study participation is independent from the therapy decision.

You may qualify if:

  • Signed patient informed consent
  • Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
  • Age between 18 and 80 years

You may not qualify if:

  • Body Mass Index (BMI) \> 40 kg/m²
  • Foreseeable life expectancy under 5 years
  • Comorbidities and known medical circumstances which would affect the clinical or functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation
  • Patient who is mentally not able to understand the study and the study conduct
  • Patients who will be foreseeable non-compliant to the planned routine interventions and study related follow-ups
  • Prisoner
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Medico Imbanaco Sede Principal

Cali, Valle del Cauca Department, Colombia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Julio Cesar Palacio Villegas, Dr.

    Centro Medico Imbanaco Sede Principal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Jacobs

CONTACT

+49 (0)40 53995866k.jacobs@link-ortho.com

Romy Spitzmüller

CONTACT

r.spitzmueller@link-ortho.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 26, 2021

Study Start

July 4, 2019

Primary Completion (Estimated)

October 1, 2034

Study Completion (Estimated)

October 1, 2035

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)