ImplantsNCT02566694
Analysis of Specimens From Patients With Orthopaedic Implants
An observational study of Implants, run by Royal National Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision. Read more about this study
- Who is it for?
- Ages 11 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Implants
- What is being tested?
- Implant
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Mar 2020
- 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 11 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients will be both male and female, aged between 11-70 years.
Who may be able to join
- All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)
Who cannot join
- Patients not consenting to the study
Trial locations and contacts
1 site in 1 country.
Iva Hauptmannova, BSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal National Orthopaedic Hospital
Stanmore, London, HA7 4LP
Alister Hart, MD,FRCSG, a.hart@ucl.ac.uk
John Skinner, FRCS(Orth)
About this study
The investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision.
Read the detailed description
The following tests will then be arranged:
- Tribological assessment. The investigators will measure the wear of the explants using: 1) 'out of roundness'; and 2) Coordinate measuring. Semi-quantitative assessment of damage to the explants will also be conducted
- Histological assessment. Tissue sent in formalin may determine the biomarker of diagnosis of metal ion synovitis where applicable
- Metal ion measurement in body fluids where applicable (in patients with metal implants)
- Diamond Light Source (this was approved in the 1st amendment). The tests will involve subjecting formalin fixed tissue to the high energy electron beam of the Diamond Light Source
- Destructive testing of the implant is allowed by the patient (after all non-destructive tests have been performed)
- Protein analysis of fluid and tissue if provided
- Titanium levels from blood samples if provided
- Gene expression testing to assess and understand mechanism of inflammation where applicable
- Conditions
- Implants
- Being tested
- Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantProcedure or surgery
orthopaedic implant
| Study group | Role | What they receive |
|---|---|---|
| Failed implants | All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants) Receives: Procedure: Implant | |
| Controls with different failure modes | We will compare findings with different types of orthopaedic implants and categories of failure mode. Receives: Procedure: Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cause of failure
Measured: At time of failure which is likely to be an average of 5 years post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImplantsStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal National Orthopaedic Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Coxa, Hospital for Joint Replacement
- Responsible party
- Principal investigator, Professor Alister Hart, Royal National Orthopaedic Hospital NHS Trust
- Investigators
- Alister Hart, FRCSG(Orth), Principal investigator, RNOH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566694
- Sponsor's protocol ID
- RNOH LIRC
- Status last verified
- Apr 2017
- First submitted
- 30 Sep 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Specimens From Patients With Orthopaedic Implants
- ClinicalTrials.gov ID
- NCT02566694
- Acronym / sponsor ID
- RNOH LIRC
- Conditions
- Implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Royal National Orthopaedic Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Coxa, Hospital for Joint Replacement
- Study start
- Mar 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 2 Oct 2015 (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 investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision.
Detailed description
The following tests will then be arranged:
- Tribological assessment. The investigators will measure the wear of the explants using: 1) 'out of roundness'; and 2) Coordinate measuring. Semi-quantitative assessment of damage to the explants will also be conducted
- Histological assessment. Tissue sent in formalin may determine the biomarker of diagnosis of metal ion synovitis where applicable
- Metal ion measurement in body fluids where applicable (in patients with metal implants)
- Diamond Light Source (this was approved in the 1st amendment). The tests will involve subjecting formalin fixed tissue to the high energy electron beam of the Diamond Light Source
- Destructive testing of the implant is allowed by the patient (after all non-destructive tests have been performed)
- Protein analysis of fluid and tissue if provided
- Titanium levels from blood samples if provided
- Gene expression testing to assess and understand mechanism of inflammation where applicable
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Failed implants | – | Procedure: ImplantAll patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants) |
| Controls with different failure modes | – | Procedure: ImplantWe will compare findings with different types of orthopaedic implants and categories of failure mode. |
Who may qualify
- Ages
- 11 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be both male and female, aged between 11-70 years.
Key inclusion criteria (1 listed)
- All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)
Key exclusion criteria (1 listed)
- Patients not consenting to the study
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 |
|---|---|---|
| Implantorthopaedic implant | Procedure or surgery | Controls with different failure modes, Failed implants |
Primary outcome
Cause of failure
Time frame: At time of failure which is likely to be an average of 5 years post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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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.
Iva Hauptmannova, BSc contact
Alister Hart, FRCSG(Orth) principal investigator
RNOH
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 Implants, run by Royal National Orthopaedic Hospital NHS Trust 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 1 inclusion and 1 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 12 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iva Hauptmannova, BSc (Iva.Hauptmannova@rnoh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cause of failure (time frame: At time of failure which is likely to be an average of 5 years post operative). 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 Apr 2017.