InfectionNCT02779504
Post Market Clinical Follow Up Study for Evaluation of Agluna® METS
An observational study of Infection, run by Stryker Orthopaedics at 1 site in United Kingdom.
Trial summary
The Agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of the METS (Modular Endoprosthetic Tumour System) medical devices, in order to reduce the risk of post surgical infections after orthopaedic endoprosthetic replacement surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Infection
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Dec 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female subjects aged between 18 years and 70 years who have been implanted with a METS™ modular implant at the Royal National Orthopaedic Hospital, Stanmore and the patient has been followed up for at least 12 months following implantation
Who may be able to join
- Implanted with a METS™ modular implant at the Royal National Orthopaedic Hospital, Stanmore.
- Patient was between 18 years old and 70 years old at the time of implantation.
- Patient has been followed up for at least 12 months following implant surgery
Who cannot join
- Patient is obese
- Patient is currently or has been involved in pending litigation or worker's compensation
- Patient has participated in another clinical investigation or study with an investigational medical device within the last 60 days
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal National Orthopaedic Hospital
Stanmore, HA7 4LP
About this study
Official title: Post Market Clinical Follow Up for the Evaluation of Reducing the Risk of Infection Using the Agluna® Treated METS Modular System
The Agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of the METS (Modular Endoprosthetic Tumour System) medical devices, in order to reduce the risk of post surgical infections after orthopaedic endoprosthetic replacement surgery.
This Post Market Clinical Follow up study is designed to retrospectively establish the infection rate of a cohort patients who have received an Agluna® Treated METS implant and compare the clinical data to patients that have received an untreated METS implant; in order to provide evidence to support the investigators' clinical claims.
Read the detailed description
This post-market clinical follow-up study will be a retrospective data comparison study of a series of Agluna® treated and untreated METS™ modular prostheses conducted at the Royal National Orthopaedic Hospital, Stanmore. The expected sample size will be 106, with 53 patients in each treatment arm (Agluna® treated vs untreated). However there will be an initial pilot of 20 subjects to evaluate the feasibility of the study conduct and to identify if any further study design modification are required.
The primary outcome is the estimation of the infection rate over 12 months following an Agluna (silver) treated METS™ endoprosthetic surgery. This will be compared to the infection rate of non-Agluna Treated devices in a similar population. Incidence of infection will be measured according to the accepted definition of periprosthetic joint infection from the American Academy of Orthopedic Surgeons. The study follow up period is 12 months after implantation. Secondary objectives are to examine the health economic impacts of using the Agluna® Treated METS™ Modular Tumour System in comparison to the untreated METS™ Modular Tumour System and to establish clinically relevant superiority of the Agluna® Treated METS™ Modular Tumour System in comparison to untreated METS™ Modular Tumour System.
- Conditions
- Infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Agluna treated METS | Patient implanted with Agluna treated METS | |
| Untreated METS | Patient implanted with untreated METS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rate in Agluna Treated METS in comparison to infection rate in untreated METs
The estimation of peri-prosthetic infection rate over twelve months following implantation with the Agluna® Treated METS™ Modular Tumour System. This will be compared to the infection rate of non- Agluna® Treated endoprostheses in a similar population.
Measured: Within 12 months following implantation of the METs implant
Secondary outcomes (2)
Health Economic Impacts of Agluna Treated METS versus Untreated METS will be examined by performing a cost analysis of the procedures
To examine the health economic impacts of using the Agluna® Treated METS™ Modular Tumour System in comparison to the untreated METS™ Modular Tumour System, health economic questions will be addressed by analysing the costs of both treatments arms based on different models with varying assumptions for costs.
Measured: 12 months follow up post implantation
Superiority of the Agluna® Treated METS™ over the untreated METS for infection reduction will be established if the confidence interval lies below 0.
To establish clinically relevant superiority of the Agluna® Treated METS™ Modular Tumour System in comparison to untreated METS™ Modular Tumour System, Investigation of superiority will be done analogously to the primary analysis. If the confidence interval lies completely below 0 superiority can be concluded. Additionally, to evaluate a clinical relevance the difference in infection rates will be analysed and interpreted numerically.
Measured: 12 months follow up post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William JS Aston, MBBSMRCSFRCS, Principal investigator, Royal National Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779504
- Sponsor's protocol ID
- 16-01
- Status last verified
- Oct 2018
- First submitted
- 12 May 2016
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual patient data will not be made available as all patient data is anonymised and therefore can not be traced back to individual patients
Publications
Wafa H, Grimer RJ, Reddy K, Jeys L, Abudu A, Carter SR, Tillman RM. Retrospective evaluation of the incidence of early periprosthetic infection with silver-treated endoprostheses in high-risk patients: case-control study. Bone Joint J. 2015 Feb;97-B(2):252-7. doi: 10.1302/0301-620X.97B2.34554.
PubMed 25628291
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow Up for the Evaluation of Reducing the Risk of Infection Using the Agluna® Treated METS Modular System
- ClinicalTrials.gov ID
- NCT02779504
- Acronym / sponsor ID
- 16-01
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 May 2016 (estimated)
- 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.
The Agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of the METS (Modular Endoprosthetic Tumour System) medical devices, in order to reduce the risk of post surgical infections after orthopaedic endoprosthetic replacement surgery.
This Post Market Clinical Follow up study is designed to retrospectively establish the infection rate of a cohort patients who have received an Agluna® Treated METS implant and compare the clinical data to patients that have received an untreated METS implant; in order to provide evidence to support the investigators' clinical claims.
Detailed description
This post-market clinical follow-up study will be a retrospective data comparison study of a series of Agluna® treated and untreated METS™ modular prostheses conducted at the Royal National Orthopaedic Hospital, Stanmore. The expected sample size will be 106, with 53 patients in each treatment arm (Agluna® treated vs untreated). However there will be an initial pilot of 20 subjects to evaluate the feasibility of the study conduct and to identify if any further study design modification are required.
The primary outcome is the estimation of the infection rate over 12 months following an Agluna (silver) treated METS™ endoprosthetic surgery. This will be compared to the infection rate of non-Agluna Treated devices in a similar population. Incidence of infection will be measured according to the accepted definition of periprosthetic joint infection from the American Academy of Orthopedic Surgeons. The study follow up period is 12 months after implantation. Secondary objectives are to examine the health economic impacts of using the Agluna® Treated METS™ Modular Tumour System in comparison to the untreated METS™ Modular Tumour System and to establish clinically relevant superiority of the Agluna® Treated METS™ Modular Tumour System in comparison to untreated METS™ Modular Tumour System.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agluna treated METS | – | –Patient implanted with Agluna treated METS |
| Untreated METS | – | –Patient implanted with untreated METS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female subjects aged between 18 years and 70 years who have been implanted with a METS™ modular implant at the Royal National Orthopaedic Hospital, Stanmore and the patient has been followed up for at least 12 months following implantation
Key inclusion criteria (3 listed)
- Implanted with a METS™ modular implant at the Royal National Orthopaedic Hospital, Stanmore.
- Patient was between 18 years old and 70 years old at the time of implantation.
- Patient has been followed up for at least 12 months following implant surgery
Key exclusion criteria (3 listed)
- Patient is obese
- Patient is currently or has been involved in pending litigation or worker's compensation
- Patient has participated in another clinical investigation or study with an investigational medical device within the last 60 days
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
Infection rate in Agluna Treated METS in comparison to infection rate in untreated METs
Time frame: Within 12 months following implantation of the METs implant
The estimation of peri-prosthetic infection rate over twelve months following implantation with the Agluna® Treated METS™ Modular Tumour System. This will be compared to the infection rate of non- Agluna® Treated endoprostheses in a similar population.
2 secondary outcomes
Health Economic Impacts of Agluna Treated METS versus Untreated METS will be examined by performing a cost analysis of the procedures
Time frame: 12 months follow up post implantation
Superiority of the Agluna® Treated METS™ over the untreated METS for infection reduction will be established if the confidence interval lies below 0.
Time frame: 12 months follow up post implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Background: PubMed 25628291Wafa H, Grimer RJ, Reddy K, Jeys L, Abudu A, Carter SR, Tillman RM. Retrospective evaluation of the incidence of early periprosthetic infection with silver-treated endoprostheses in high-risk patients: case-control study. Bone Joint J. 2015 Feb;97-B(2):252-7. doi: 10.1302/0301-620X.97B2.34554.
- Individual participant dataSharing planned: No. Individual patient data will not be made available as all patient data is anonymised and therefore can not be traced back to individual patients
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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.
William JS Aston, MBBSMRCSFRCS principal investigator
Royal National Orthopaedic Hospital
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 Infection, run by Stryker Orthopaedics at 1 site in United Kingdom.
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 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: finished, as of the sponsor's last update on 22 Oct 2018. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Infection rate in Agluna Treated METS in comparison to infection rate in untreated METs (time frame: Within 12 months following implantation of the METs implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02779504, which also lists 1 linked publication.
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 22 Oct 2018.