CardiomyopathyNCT02331264
Cardiac Assessment of Patients With Hip Implants
An observational study of Cardiomyopathy and Cardiac Failure, run by Royal National Orthopaedic Hospital NHS Trust at 2 sites in United Kingdom.
Trial summary
PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on cardiac function STUDY OUTCOME MEASURES To assess the effect of metal ions from hip implants on cardiac function as measured by Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy, Cardiac Failure
- What is being tested?
- Exposure to metal debris
- How many people
- 90 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2014to Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with hip replacements. Groups 1 and 2 include patients with Metal on Metal hip replacements. Group 3 includes patients with non Metal bearing hip replacements including Ceramic on Ceramic Hip replacements. All three groups will be matched for Age, Sex, Time since hip Implantation, and diabetes status.
Who may be able to join
- Age over 18 years of age
- Either male or female
- Metal on Metal hip implant (ceramic on ceramic hip implant for patients within control group)
- Implanted greater than 12 months (i.e. beyond the bedding in period of the implant)
- Suitable for MRI scanning (no contraindications for Magnetic scanning - for instance metal implants in eyes/brain/heart, and claustrophobia)
- Consenting to the proposed research activity
Who cannot join
- Age below 18 years
- Metal hip implant not considered as MOM or Ceramic on Ceramic (COC) if part of the control group
- Not suitable to undergo MRI scanning (contra-indications or claustrophobia)
- Revised hip implant
- Atrial Fibrillation
- Poor renal function (eGFR<30)
- Consent not given
- Vulnerable adults
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Heart Hospital
London, London, W1G 8PH
Royal National Orthopaedic Hospital
Stanmore, London, HA7 4LP
About this study
PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on cardiac function
STUDY OUTCOME MEASURES
Read more
To assess the effect of metal ions from hip implants on cardiac function as measured by Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram. This involves the surrogate detection of cobalt ion deposition within cardiac tissues and assessment of ejection fraction and tissue characterization (with and without contrast).
STUDY IMPACT
With 60,000 patients having a metal on metal (MOM) hip implant in the United Kingdom (UK), and over a million worldwide, there is need to clarify this important question, which is the source of significant concern amongst patients and surgeons alike. Also, this problem is not unique to MOM hips since all hip implants contain metal and as seen in various case reports high blood cobalt levels have arisen after catastrophic failure (e.g. fracture of a ceramic bearing surface) leading to abnormal wear of the implant and release of metal ions into the body. In the UK, over 80,000 hip implants are inserted annually.
Read the detailed description
BACKGROUND
Metal-on-metal (MOM) hip implants have a risk of releasing metal ions upon wear of the component material. Some of the metal ions (e.g. cobalt and chromium) from the metal implant or from the metal particles will enter the bloodstream.
The Food and Drug Administration (FDA, USA) recently highlighted systemic toxicity from metal on metal hip implants as a cause for concern and recommended that patients with systemic symptoms are assessed with a particular focus on cardiovascular, neurological, endocrinological (especially thyroid), and renal systems.
A number of cases of suspected toxicity to circulating cobalt and chromium from MOM hip implants, including cardiac toxicity, have been reported recently. The most profound case involves a patient who died from cardiac failure secondary to cardiomyopathy and cobalt deposition within the cardiac tissues. A recent cross sectional health screen and isolated case reports, suggest that raised metal ion levels have the potential to cause cardiomyopathy and cardiac failure. Such cases have raised public anxiety in the process.
Blood metal ions released from metal hip implants are increasingly recognized as a potential cause of local and distant abnormal tissue responses, since cobalt and chromium is released into the peri-prosthetic tissues and transported systemically throughout the body. Component design and positioning are associated with increased wear and as a result raised metal ion levels. However, a definitive causal link to systemic symptoms still remains to be established.
Iron overload disorders affecting the heart or liver is a significant cause of morbidity in primary and secondary haemochromatosis and thalassaemia. Excessive iron deposition within cardiac tissues can lead to premature death secondary to fatal arrhythmias and heart failure. Cardiovascular magnetic resonance (CMR) imaging has revolutionised the management of this particular group of patients by allowing a robust non-invasive method of detecting iron loading.
CMR is the gold-standard method of assessing cardiac volumes, function and mass. It's unique strength over other imaging modalities is tissue characterization with and without the use of contrast agents. Myocardial iron is detected due to the effects on relaxation times through the interaction of iron with hydrogen nuclei in normal cardiac tissue. Cobalt is a ferromagnetic metal containing unpaired electrons allowing it to align in parallel to applied magnetic fields, and therefore should be detected by MRI in a similar way to iron.
RATIONALE
No study has attempted to identify cobalt deposition within cardiac tissue using cardiac MRI. We therefore aim to detect cobalt deposition in the cardiac tissue of patients with metal hip implants and markedly raised cobalt blood ion levels. If detected, we aim to assess whether this had any clinical effect on cardiac function.
Our hypothesis is that there is no discernable effect on cardiac function detectable on Cardiac MRI and Echocardiography in patients with raised blood cobalt ion levels.
Case Controlled Cohort Observation study
Three groups of patients will be identified with Hip implants (matched for age, sex and time since surgery).
- Patients with MOM hip implant and raised metal ion level (>7ppb) - N=30
- Patients with MOM hip implant and Normal Metal ion level (<7ppb) - N=30
- Patients with non-metal bearing hip implant (Ceramic on Ceramic/Polyethylene (COC/COP)) - N=30
Selection into each group will be defined by metal ion blood tests and hip implant type. Patients with two consecutive blood tests at the appropriate level and less than 10% variation (in the last 12 months) will be included, or those with a blood test at the appropriate level taken in the last 3 months will be included.
The cardiologist will be blinded with regards to patient grouping, to ensure there is no bias when reporting the clinical and cardiological investigations results in light of the presence or absence of raised blood metal ions.
All participants enrolled will:
- Be assessed by a cardiologist
- Have a cardiac MRI, an ECHOcardiogram, and an Electrocardiogram (ECG)
These clinical data will be analysed and compared to assess if a significant difference exists between the 3 groups.
- Conditions
- Cardiomyopathy, Cardiac Failure
- Being tested
- Exposure to metal debris
- Keywords
- Cardiac Toxicity, Metal on Metal Hip Implants
- Medical subject headings
- Cardiomyopathies, Heart Failure, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to metal debrisOther
The 3 groups are defined by the patients exposure to metal debris from a hip implant. This is either elevated metal ions in those with poorly functioning metal on metal hip implants, or low metal ion levels in those with well functioning metal hip implants, and a second control group of patients with non melt bearing hip implants.
| Study group | Role | What they receive |
|---|---|---|
| MoM >7ppb | Patients with Metal on Metal hip implants and blood metal ions above the Medicines and Healthcare Products Regulatory Agency (MHRA) threshold of 7 parts per billion Receives: Other: Exposure to metal debris | |
| MoM <7ppb | Patients with Metal on Metal hip implants and blood metal ions below the MHRA threshold of 7 parts per billion | |
| Non MoM | Patients with non Metal bearing hip implants such as Ceramic on Ceramic or Plastic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Ejection Fraction
Use of Echocardiogram and Cardiac MRI (Gold Standard) for assessment of ejection fraction of the heart
Measured: 1 hour
Secondary outcomes (1)
Detection of Cobalt Metal Ion deposition within cardiac tissues
Use of Cardiac MRI series T1 and T2* relaxation times, which correlate with metal debris within cardiac tissues
Measured: 30 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies 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
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal National Orthopaedic Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Principal investigator, Professor Alister Hart, Royal National Orthopaedic Hospital NHS Trust
- Investigators
- Alister Hart, MD,FRCSG, Principal investigator, Professor of Orthopaedic Surgery at UCL and Consultant Orthopaedic Surgeon at the RNOH. Director of research and development at the RNOH.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331264
- Sponsor's protocol ID
- 157144
- Status last verified
- Apr 2016
- First submitted
- 2 Jan 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: publication submitted
Publications
Steens W, von Foerster G, Katzer A. Severe cobalt poisoning with loss of sight after ceramic-metal pairing in a hip--a case report. Acta Orthop. 2006 Oct;77(5):830-2. doi: 10.1080/17453670610013079. No abstract available.
PubMed 17068719Rizzetti MC, Liberini P, Zarattini G, Catalani S, Pazzaglia U, Apostoli P, Padovani A. Loss of sight and sound. Could it be the hip? Lancet. 2009 Mar 21;373(9668):1052. doi: 10.1016/S0140-6736(09)60490-6. No abstract available.
PubMed 19304018Ikeda T, Takahashi K, Kabata T, Sakagoshi D, Tomita K, Yamada M. Polyneuropathy caused by cobalt-chromium metallosis after total hip replacement. Muscle Nerve. 2010 Jul;42(1):140-3. doi: 10.1002/mus.21638.
PubMed 20544916Oldenburg M, Wegner R, Baur X. Severe cobalt intoxication due to prosthesis wear in repeated total hip arthroplasty. J Arthroplasty. 2009 Aug;24(5):825.e15-20. doi: 10.1016/j.arth.2008.07.017. Epub 2008 Oct 2.
PubMed 18835128Tower SS. Arthroprosthetic cobaltism: neurological and cardiac manifestations in two patients with metal-on-metal arthroplasty: a case report. J Bone Joint Surg Am. 2010 Dec 1;92(17):2847-51. doi: 10.2106/JBJS.J.00125. Epub 2010 Oct 29. No abstract available.
PubMed 21037026Tower SS. Arthroprosthetic cobaltism associated with metal on metal hip implants. BMJ. 2012 Jan 17;344:e430. doi: 10.1136/bmj.e430. No abstract available.
PubMed 22252702Mao X, Wong AA, Crawford RW. Cobalt toxicity--an emerging clinical problem in patients with metal-on-metal hip prostheses? Med J Aust. 2011 Jun 20;194(12):649-51. doi: 10.5694/j.1326-5377.2011.tb03151.x.
PubMed 21692725Gilbert CJ, Cheung A, Butany J, Zywiel MG, Syed K, McDonald M, Wong F, Overgaard C. Hip pain and heart failure: the missing link. Can J Cardiol. 2013 May;29(5):639.e1-2. doi: 10.1016/j.cjca.2012.10.015. Epub 2013 Jan 9.
PubMed 23313008Prentice JR, Clark MJ, Hoggard N, Morton AC, Tooth C, Paley MN, Stockley I, Hadjivassiliou M, Wilkinson JM. Metal-on-metal hip prostheses and systemic health: a cross-sectional association study 8 years after implantation. PLoS One. 2013 Jun 10;8(6):e66186. doi: 10.1371/journal.pone.0066186. Print 2013.
PubMed 23762480Machado C, Appelbe A, Wood R. Arthroprosthetic cobaltism and cardiomyopathy. Heart Lung Circ. 2012 Nov;21(11):759-60. doi: 10.1016/j.hlc.2012.03.013. Epub 2012 Apr 18.
PubMed 22520206Cohen D. How safe are metal-on-metal hip implants? BMJ. 2012 Feb 28;344:e1410. doi: 10.1136/bmj.e1410. No abstract available.
PubMed 22374741Jacobs JJ, Skipor AK, Patterson LM, Hallab NJ, Paprosky WG, Black J, Galante JO. Metal release in patients who have had a primary total hip arthroplasty. A prospective, controlled, longitudinal study. J Bone Joint Surg Am. 1998 Oct;80(10):1447-58. doi: 10.2106/00004623-199810000-00006.
PubMed 9801213Case CP, Langkamer VG, James C, Palmer MR, Kemp AJ, Heap PF, Solomon L. Widespread dissemination of metal debris from implants. J Bone Joint Surg Br. 1994 Sep;76(5):701-12.
PubMed 8083255Merritt K, Brown SA. Release of hexavalent chromium from corrosion of stainless steel and cobalt-chromium alloys. J Biomed Mater Res. 1995 May;29(5):627-33. doi: 10.1002/jbm.820290510.
PubMed 7622548De Haan R, Pattyn C, Gill HS, Murray DW, Campbell PA, De Smet K. Correlation between inclination of the acetabular component and metal ion levels in metal-on-metal hip resurfacing replacement. J Bone Joint Surg Br. 2008 Oct;90(10):1291-7. doi: 10.1302/0301-620X.90B10.20533.
PubMed 18827237
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Assessment of Patients With Hip Implants
- ClinicalTrials.gov ID
- NCT02331264
- Acronym / sponsor ID
- 157144
- Conditions
- Cardiomyopathy, Cardiac Failure
- Keywords
- Cardiac Toxicity, Metal on Metal Hip Implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Royal National Orthopaedic Hospital NHS TrustUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Jan 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.
PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on cardiac function
STUDY OUTCOME MEASURES
To assess the effect of metal ions from hip implants on cardiac function as measured by Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram. This involves the surrogate detection of cobalt ion deposition within cardiac tissues and assessment of ejection fraction and tissue characterization (with and without contrast).
STUDY IMPACT
With 60,000 patients having a metal on metal (MOM) hip implant in the United Kingdom (UK), and over a million worldwide, there is need to clarify this important question, which is the source of significant concern amongst patients and surgeons alike. Also, this problem is not unique to MOM hips since all hip implants contain metal and as seen in various case reports high blood cobalt levels have arisen after catastrophic failure (e.g. fracture of a ceramic bearing surface) leading to abnormal wear of the implant and release of metal ions into the body. In the UK, over 80,000 hip implants are inserted annually.
Detailed description
BACKGROUND
Metal-on-metal (MOM) hip implants have a risk of releasing metal ions upon wear of the component material. Some of the metal ions (e.g. cobalt and chromium) from the metal implant or from the metal particles will enter the bloodstream.
The Food and Drug Administration (FDA, USA) recently highlighted systemic toxicity from metal on metal hip implants as a cause for concern and recommended that patients with systemic symptoms are assessed with a particular focus on cardiovascular, neurological, endocrinological (especially thyroid), and renal systems.
A number of cases of suspected toxicity to circulating cobalt and chromium from MOM hip implants, including cardiac toxicity, have been reported recently. The most profound case involves a patient who died from cardiac failure secondary to cardiomyopathy and cobalt deposition within the cardiac tissues. A recent cross sectional health screen and isolated case reports, suggest that raised metal ion levels have the potential to cause cardiomyopathy and cardiac failure. Such cases have raised public anxiety in the process.
Blood metal ions released from metal hip implants are increasingly recognized as a potential cause of local and distant abnormal tissue responses, since cobalt and chromium is released into the peri-prosthetic tissues and transported systemically throughout the body. Component design and positioning are associated with increased wear and as a result raised metal ion levels. However, a definitive causal link to systemic symptoms still remains to be established.
Iron overload disorders affecting the heart or liver is a significant cause of morbidity in primary and secondary haemochromatosis and thalassaemia. Excessive iron deposition within cardiac tissues can lead to premature death secondary to fatal arrhythmias and heart failure. Cardiovascular magnetic resonance (CMR) imaging has revolutionised the management of this particular group of patients by allowing a robust non-invasive method of detecting iron loading.
CMR is the gold-standard method of assessing cardiac volumes, function and mass. It's unique strength over other imaging modalities is tissue characterization with and without the use of contrast agents. Myocardial iron is detected due to the effects on relaxation times through the interaction of iron with hydrogen nuclei in normal cardiac tissue. Cobalt is a ferromagnetic metal containing unpaired electrons allowing it to align in parallel to applied magnetic fields, and therefore should be detected by MRI in a similar way to iron.
RATIONALE
No study has attempted to identify cobalt deposition within cardiac tissue using cardiac MRI. We therefore aim to detect cobalt deposition in the cardiac tissue of patients with metal hip implants and markedly raised cobalt blood ion levels. If detected, we aim to assess whether this had any clinical effect on cardiac function.
Our hypothesis is that there is no discernable effect on cardiac function detectable on Cardiac MRI and Echocardiography in patients with raised blood cobalt ion levels.
Case Controlled Cohort Observation study
Three groups of patients will be identified with Hip implants (matched for age, sex and time since surgery).
- Patients with MOM hip implant and raised metal ion level (>7ppb) - N=30
- Patients with MOM hip implant and Normal Metal ion level (<7ppb) - N=30
- Patients with non-metal bearing hip implant (Ceramic on Ceramic/Polyethylene (COC/COP)) - N=30
Selection into each group will be defined by metal ion blood tests and hip implant type. Patients with two consecutive blood tests at the appropriate level and less than 10% variation (in the last 12 months) will be included, or those with a blood test at the appropriate level taken in the last 3 months will be included.
The cardiologist will be blinded with regards to patient grouping, to ensure there is no bias when reporting the clinical and cardiological investigations results in light of the presence or absence of raised blood metal ions.
All participants enrolled will:
- Be assessed by a cardiologist
- Have a cardiac MRI, an ECHOcardiogram, and an Electrocardiogram (ECG)
These clinical data will be analysed and compared to assess if a significant difference exists between the 3 groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MoM >7ppb | – | Other: Exposure to metal debrisPatients with Metal on Metal hip implants and blood metal ions above the Medicines and Healthcare Products Regulatory Agency (MHRA) threshold of 7 parts per billion |
| MoM <7ppb | – | –Patients with Metal on Metal hip implants and blood metal ions below the MHRA threshold of 7 parts per billion |
| Non MoM | – | –Patients with non Metal bearing hip implants such as Ceramic on Ceramic or Plastic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hip replacements. Groups 1 and 2 include patients with Metal on Metal hip replacements. Group 3 includes patients with non Metal bearing hip replacements including Ceramic on Ceramic Hip replacements. All three groups will be matched for Age, Sex, Time since hip Implantation, and diabetes status.
Key inclusion criteria (6 listed)
- Age over 18 years of age
- Either male or female
- Metal on Metal hip implant (ceramic on ceramic hip implant for patients within control group)
- Implanted greater than 12 months (i.e. beyond the bedding in period of the implant)
- Suitable for MRI scanning (no contraindications for Magnetic scanning - for instance metal implants in eyes/brain/heart, and claustrophobia)
Key exclusion criteria (8 listed)
- Age below 18 years
- Metal hip implant not considered as MOM or Ceramic on Ceramic (COC) if part of the control group
- Not suitable to undergo MRI scanning (contra-indications or claustrophobia)
- Revised hip implant
- Atrial Fibrillation
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 |
|---|---|---|
| Exposure to metal debrisThe 3 groups are defined by the patients exposure to metal debris from a hip implant. This is either elevated metal ions in those with poorly functioning metal on metal hip implants, or low metal ion levels in those with well functioning metal hip implants, and a second control group of patients with non melt bearing hip implants. | Other | MoM >7ppb |
Primary outcome
Cardiac Ejection Fraction
Time frame: 1 hour
Use of Echocardiogram and Cardiac MRI (Gold Standard) for assessment of ejection fraction of the heart
1 secondary outcome
Detection of Cobalt Metal Ion deposition within cardiac tissues
Time frame: 30 mins
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 6 Apr 2016.
- Results publication: PubMed 17068719Steens W, von Foerster G, Katzer A. Severe cobalt poisoning with loss of sight after ceramic-metal pairing in a hip--a case report. Acta Orthop. 2006 Oct;77(5):830-2. doi: 10.1080/17453670610013079. No abstract available.
- Results publication: PubMed 19304018Rizzetti MC, Liberini P, Zarattini G, Catalani S, Pazzaglia U, Apostoli P, Padovani A. Loss of sight and sound. Could it be the hip? Lancet. 2009 Mar 21;373(9668):1052. doi: 10.1016/S0140-6736(09)60490-6. No abstract available.
- Results publication: PubMed 20544916Ikeda T, Takahashi K, Kabata T, Sakagoshi D, Tomita K, Yamada M. Polyneuropathy caused by cobalt-chromium metallosis after total hip replacement. Muscle Nerve. 2010 Jul;42(1):140-3. doi: 10.1002/mus.21638.
- Results publication: PubMed 18835128Oldenburg M, Wegner R, Baur X. Severe cobalt intoxication due to prosthesis wear in repeated total hip arthroplasty. J Arthroplasty. 2009 Aug;24(5):825.e15-20. doi: 10.1016/j.arth.2008.07.017. Epub 2008 Oct 2.
- Results publication: PubMed 21037026Tower SS. Arthroprosthetic cobaltism: neurological and cardiac manifestations in two patients with metal-on-metal arthroplasty: a case report. J Bone Joint Surg Am. 2010 Dec 1;92(17):2847-51. doi: 10.2106/JBJS.J.00125. Epub 2010 Oct 29. No abstract available.
- Results publication: PubMed 22252702Tower SS. Arthroprosthetic cobaltism associated with metal on metal hip implants. BMJ. 2012 Jan 17;344:e430. doi: 10.1136/bmj.e430. No abstract available.
- Results publication: PubMed 21692725Mao X, Wong AA, Crawford RW. Cobalt toxicity--an emerging clinical problem in patients with metal-on-metal hip prostheses? Med J Aust. 2011 Jun 20;194(12):649-51. doi: 10.5694/j.1326-5377.2011.tb03151.x.
- Results publication: PubMed 23313008Gilbert CJ, Cheung A, Butany J, Zywiel MG, Syed K, McDonald M, Wong F, Overgaard C. Hip pain and heart failure: the missing link. Can J Cardiol. 2013 May;29(5):639.e1-2. doi: 10.1016/j.cjca.2012.10.015. Epub 2013 Jan 9.
- Results publication: PubMed 23762480Prentice JR, Clark MJ, Hoggard N, Morton AC, Tooth C, Paley MN, Stockley I, Hadjivassiliou M, Wilkinson JM. Metal-on-metal hip prostheses and systemic health: a cross-sectional association study 8 years after implantation. PLoS One. 2013 Jun 10;8(6):e66186. doi: 10.1371/journal.pone.0066186. Print 2013.
- Results publication: PubMed 22520206Machado C, Appelbe A, Wood R. Arthroprosthetic cobaltism and cardiomyopathy. Heart Lung Circ. 2012 Nov;21(11):759-60. doi: 10.1016/j.hlc.2012.03.013. Epub 2012 Apr 18.
- Results publication: PubMed 22374741Cohen D. How safe are metal-on-metal hip implants? BMJ. 2012 Feb 28;344:e1410. doi: 10.1136/bmj.e1410. No abstract available.
- Results publication: PubMed 9801213Jacobs JJ, Skipor AK, Patterson LM, Hallab NJ, Paprosky WG, Black J, Galante JO. Metal release in patients who have had a primary total hip arthroplasty. A prospective, controlled, longitudinal study. J Bone Joint Surg Am. 1998 Oct;80(10):1447-58. doi: 10.2106/00004623-199810000-00006.
- Individual participant dataSharing planned: Yes. publication submitted
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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.
Alister Hart, MD,FRCSG principal investigator
Professor of Orthopaedic Surgery at UCL and Consultant Orthopaedic Surgeon at the RNOH. Director of research and development at the RNOH.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy and Cardiac Failure, run by Royal National Orthopaedic Hospital NHS Trust at 2 sites 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 6 inclusion and 8 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 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cardiac Ejection Fraction (time frame: 1 hour). 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 NCT02331264, which also lists 49 linked publications.
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 6 Apr 2016.