Clinical trial NCT04858347: Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
Official title: Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis in Short-, Mid-, and Longterm Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthrosis of Knee
Lead sponsor: Waldemar Link GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: The GEMINI SL Fixed Bearing PS knee prosthesis combines clinical proven design features with state-of-the-art-technology in order to achieve a high standard clinical performance, surgical efficiency and safety. Currently, no mid- and longterm clinical data are available for the GEMINI SL Fixed Bearing PS knee prosthesis. Therefore, the study is designed to generate clinical data of the GEMINI SL Fixed Bearing PS knee prosthesis in the 10-year follow-up under routine condition.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 10-year survival rate of the Gemini SL Fixed Bearing PS knee prothesis
timeFrame: 10 years
Secondary outcomes:
measure: Survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis
timeFrame: after 6 months, 1,3 and 5 years
measure: Change in functional and clinical outcome (KOOS)
timeFrame: preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years
measure: Change in functional and clinical outcome (KSS)
timeFrame: preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years
measure: Complications rate
timeFrame: Intraoperative examinations to 10-year follow-up examination
measure: Subsequent surgical interventions
timeFrame: postoperative examinations up to 10-year follow-up examination
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Centro Medico Imbanaco Sede Principal
state: Valle Del Cauca
Study officials:
affiliation: Centro Medico Imbanaco Sede Principal
name: Julio Cesar Palacio Villegas, Dr.
role: PRINCIPAL_INVESTIGATOR
References: