Osteoarthrosis of KneeNCT04858347
Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
An observational study of Osteoarthrosis of Knee, run by Waldemar Link GmbH & Co. KG at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthrosis of Knee
- What is being tested?
- Total knee replacement
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteColombia
- Study dates
- 4 Jul 2019to Oct 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Signed patient informed consent
- Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
- Age between 18 and 80 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romy Spitzmüller contact
Colombia1 site, 1 recruiting
- Recruiting
Centro Medico Imbanaco Sede Principal
Cali, Valle del Cauca Department
Julio Cesar Palacio Villegas, Dr., +57 (310) 820 42 29, gruporeemplazosarticulares@gmail.com
Julio Cesar Palacio Villegas, Dr.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthrosis of Knee
- Being tested
- Total knee replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (5)
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: postoperative examinations up to 10-year follow-up examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start4 Jul 2019
- Primary completionOct 2034 (estimated)
- Study completionOct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthrosis of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waldemar Link GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julio Cesar Palacio Villegas, Dr., Principal investigator, Centro Medico Imbanaco Sede Principal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858347
- Sponsor's protocol ID
- KP11
- Status last verified
- Jan 2023
- First submitted
- 14 Apr 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis in Short-, Mid-, and Longterm Follow-up
- ClinicalTrials.gov ID
- NCT04858347
- Acronym / sponsor ID
- KP11
- Conditions
- Osteoarthrosis of Knee
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Waldemar Link GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- Oct 2034 (estimated)
- Study completion
- Oct 2035 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Signed patient informed consent
- Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
- Age between 18 and 80 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee replacementImplantation of the GEMINI SL Fixed Bearing PS knee prosthesis. The operation technique of the GEMINI SL Fixed Bearing PS knee prosthesis will be followed. | Device | – |
Primary outcome
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.
5 secondary outcomes
Survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis
Time frame: after 6 months, 1,3 and 5 years
Change in functional and clinical outcome (KOOS)
Time frame: preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years
Change in functional and clinical outcome (KSS)
Time frame: preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years
Complications rate
Time frame: Intraoperative examinations to 10-year follow-up examination
Subsequent surgical interventions
Time frame: postoperative examinations up to 10-year follow-up examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romy Spitzmüller contact
Julio Cesar Palacio Villegas, Dr. principal investigator
Centro Medico Imbanaco Sede Principal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthrosis of Knee, run by Waldemar Link GmbH & Co. KG at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim Jacobs (+49 (0)40 53995866, k.jacobs@link-ortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-year survival rate of the Gemini SL Fixed Bearing PS knee prothesis (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.