Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis

Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis in Short-, Mid-, and Longterm Follow-up

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthrosis of Knee
• Intervention / Treatment: Device: Total knee replacement

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.

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Kim Jacobs; Phone Number: +49 (0)40 53995866; Email: k.jacobs@link-ortho.com
• Study Contact Backup: Name: Romy Spitzmüller; Email: r.spitzmueller@link-ortho.com

Study Locations

• Colombia
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia
      • Recruiting
      • Centro Medico Imbanaco Sede Principal
      • Contact: Julio Cesar Palacio Villegas, Dr.; Phone Number: +57 (310) 820 42 29; Email: gruporeemplazosarticulares@gmail.com
      • Principal Investigator: Julio Cesar Palacio Villegas, Dr.
      • Sub-Investigator: Daniel Carvajal, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis	Survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis after 6 months, 1, 3 and 5 years	after 6 months, 1,3 and 5 years
Change in functional and clinical outcome (KOOS)	Evaluation of the change in functional and clinical outcome from preoperative to 6 months, 1, 3, 5 and 10 years postoperative, measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS is a reliable and validated knee-specific patient-administered outcome instrument. The previous week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 (best result) to 4 (worst result). The KOOS consists of 5 sub-scales: Pain, Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and Hip/Knee related Quality of life (QoL). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years
Change in functional and clinical outcome (KSS)	Evaluation of the change in functional and clinical outcome from preoperative to 6 months, 1, 3, 5 and 10 years postoperative, measured by the Knee Society Score (KSS). The KSS is a frequently used, reliable and validated score in the assessment of a subject's knee pain and functional knee capacity. It comprises two arms, the functional ability and the clinical examination score, each ranging from 0 points (worst result) to 100 points (best result).	preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years
Complications rate	Complications related to implantation of the GEMINI SL Fixed Bearing PS knee prosthesis (infections, dislocations, migrations, aseptic loosenings, periprosthetic fractures, intra-operative fractures, implant fractures, soft tissue fractures, joint instability etc.) will be recorded at all follow-up examinations.	Intraoperative examinations to 10-year follow-up examination
Subsequent surgical interventions	All subsequent surgical interventions at the operated knee (exchange of the polyethylene plateau, additional implantation/exchange of the patella component, soft-tissue balancing, debridement etc) will be recorded at all follow-up examinations.	postoperative examinations up to 10-year follow-up examination

Collaborators and Investigators

• Sponsor: Waldemar Link GmbH & Co. KG
• Investigators: Principal Investigator: Julio Cesar Palacio Villegas, Dr., Centro Medico Imbanaco Sede Principal

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2019
• Primary Completion (Anticipated): October 1, 2034
• Study Completion (Anticipated): October 1, 2035

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: KP11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No