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NCT Number: NCT04858347

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

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.

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Key information

Conditions

Osteoarthrosis of Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Medico Imbanaco Sede Principal

Cali, Valle del Cauca Department, Colombia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee replacement

Device

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.

Primary outcomes

  1. 10-year survival rate of the Gemini SL Fixed Bearing PS knee prothesis

    Time frame: 10 years

    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.

Secondary outcomes

  1. Survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis

    Time frame: after 6 months, 1,3 and 5 years

    Survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis after 6 months, 1, 3 and 5 years

  2. Change in functional and clinical outcome (KOOS)

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

    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.

  3. Change in functional and clinical outcome (KSS)

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

    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).

  4. Complications rate

    Time frame: Intraoperative examinations to 10-year follow-up examination

    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.

  5. Subsequent surgical interventions

    Time frame: postoperative examinations up to 10-year follow-up examination

    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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Waldemar Link GmbH & Co. KG

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2034
Study completion
2035
First posted
Apr 26, 2021
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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