Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
ConditionOsteoarthrosis of Knee
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorWaldemar Link GmbH & Co. KG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed patient informed consent
Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
Age between 18 and 80 years
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Total knee replacement
DeviceImplantation of the GEMINI SL Fixed Bearing PS knee prosthesis. The operation technique of the GEMINI SL Fixed Bearing PS knee prosthesis will be followed.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
10 yearsSecondary outcomes
1
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
Time frame
after 6 months, 1,3 and 5 years2
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.
Time frame
preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years3
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).
Time frame
preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years4
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.
Time frame
Intraoperative examinations to 10-year follow-up examinationSponsors and contacts
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Source ClinicalTrials.gov