Total Knee ReplacementNCT03575546
Clinical and Functional Outcome of the Gemini SL Fixed Bearing at Midterm Follow-up
An observational study of Total Knee Replacement, run by Waldemar Link GmbH & Co. KG at 3 sites in 2 countries.
Trial summary
This is a retrospective, multicenter case series with a prospective follow-up to confirm the safety and performance of the Gemini SL Fixed Bearing knee prosthesis in midterm follow-up under routine conditions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Knee Replacement
- How many people
- 254 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Jul 2018to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Adult, Older adult
Study population: All patients received a Gemini SL Fixed Bearing knee prosthesis in the study sites 3 years ago are possible participants of the study. Hospital charts will be screened in order to identify these candidates. The patients will be followed up at 3-year interval.
Who may be able to join
- Implantation of a Gemini SL Fixed Bearing knee prostheses 3 years ago
- Age between 18 and 75 years at the time of implantation
Who cannot join
- Body Mass Index (BMI) > 40 kg/m² at the time of implantation
- Comorbidities and known medical circumstances which would affect the clinical functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation
- Prisoner
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Klinik Oberammergau
Oberammergau, 82487
Universitätsklinikum Tübingen für Orthopädie
Tübingen, 72076
About this study
This is a retrospective, multicenter case series with a prospective follow-up to confirm the safety and performance of the Gemini SL Fixed Bearing knee prosthesis in midterm follow-up under routine conditions. Primary outcome of the study is the 5-year survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point.
Read the detailed description
Sufficient data (e.g. biomechanical tests, biocompatibility, vigilance data and results of risk management, clinical data of comparable devices) are available for assessing the safety and performance of the Gemini SL knee prosthesis system. Unfortunately, no data are available for the Gemini SL Fixed Bearing knee prosthesis. As one part of the post market surveillance (PMS) system of the sponsor, the clinical outcome of the Gemini SL Fixed Bearing knee prosthesis in the midterm follow-up shall be evaluated. Therefore patients who received a Gemini Sl Fixed bearing knee prosthesis 3 years ago are invited to participate in follow-up examinations.
- Conditions
- Total Knee Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point
Revision for any reason is defined as removal, replacement or adding of any implant components, except subsequent implantation or replacement of the patella surface or the polyethylene plateau.
Measured: 5 years
Secondary outcomes (4)
Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point
Revision for any reason is defined as removal, replacement or adding of any implant components, except subsequent implantation or replacement of the patella surface or the polyethylene plateau.
Measured: 3 years
Evaluation of the functional and clinical outcome of the Gemini SL Fixed Bearing knee prosthesis measured by the Knee Society Score
Evaluation of KSS Score (Validated Score)
Measured: 3 and 5 year
Complication rates
Number and kind of complications
Measured: 3 and 5 years
Subsequent surgical interventions
Number and kind of subsequent surgical interventions
Measured: 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start24 Jul 2018
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Retrospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waldemar Link GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med. Wülker, Principal investigator, Universitätsklinikum Tübingen für Orthopädie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575546
- Sponsor's protocol ID
- KP05A
- Status last verified
- Jan 2023
- First submitted
- 15 Jun 2018
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 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 at Midterm Follow-up
- ClinicalTrials.gov ID
- NCT03575546
- Acronym / sponsor ID
- KP05A
- Conditions
- Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Waldemar Link GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 2 Jul 2018 (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 retrospective, multicenter case series with a prospective follow-up to confirm the safety and performance of the Gemini SL Fixed Bearing knee prosthesis in midterm follow-up under routine conditions. Primary outcome of the study is the 5-year survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point.
Detailed description
Sufficient data (e.g. biomechanical tests, biocompatibility, vigilance data and results of risk management, clinical data of comparable devices) are available for assessing the safety and performance of the Gemini SL knee prosthesis system. Unfortunately, no data are available for the Gemini SL Fixed Bearing knee prosthesis. As one part of the post market surveillance (PMS) system of the sponsor, the clinical outcome of the Gemini SL Fixed Bearing knee prosthesis in the midterm follow-up shall be evaluated. Therefore patients who received a Gemini Sl Fixed bearing knee prosthesis 3 years ago are invited to participate in follow-up examinations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients received a Gemini SL Fixed Bearing knee prosthesis in the study sites 3 years ago are possible participants of the study. Hospital charts will be screened in order to identify these candidates. The patients will be followed up at 3-year interval.
Key inclusion criteria (2 listed)
- Implantation of a Gemini SL Fixed Bearing knee prostheses 3 years ago
- Age between 18 and 75 years at the time of implantation
Key exclusion criteria (3 listed)
- Body Mass Index (BMI) > 40 kg/m² at the time of implantation
- Comorbidities and known medical circumstances which would affect the clinical functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point
Time frame: 5 years
Revision for any reason is defined as removal, replacement or adding of any implant components, except subsequent implantation or replacement of the patella surface or the polyethylene plateau.
4 secondary outcomes
Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point
Time frame: 3 years
Evaluation of the functional and clinical outcome of the Gemini SL Fixed Bearing knee prosthesis measured by the Knee Society Score
Time frame: 3 and 5 year
Complication rates
Time frame: 3 and 5 years
Subsequent surgical interventions
Time frame: 3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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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. This study is not recruiting at the moment.
Prof. Dr. med. Wülker principal investigator
Universitätsklinikum Tübingen für Orthopädie
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Replacement, run by Waldemar Link GmbH & Co. KG at 3 sites in 2 countries.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 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 3 sites in Germany, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point (time frame: 5 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 13 Jan 2023.