Osteoarthritis, HipNCT04585022

Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing

A study testing Magnum, Zimmer Biomet, Warsaw, IN and Recap, Zimmer Biomet, Warsaw, IN in people with Osteoarthritis, Hip, run by Hvidovre University Hospital.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The investigators aimed to investigate the possible differences in metal ion concentrations in patients following one of two types of metal-on-metal articulating hip prosthesis regarding chromium and cobalt concentration, radiological findings, patient reported outcome measures and rate of revision at 5-years follow… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Osteoarthritis, Hip
What is being tested?: Magnum, Zimmer Biomet, Warsaw, IN and Recap, Zimmer Biomet, Warsaw, IN
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: No sites listed yet
Study dates: 1 Nov 2006to 11 Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Primary or secondary hip osteoarthritis eligible for hip replacement surgery
Able to give informed consent
Able to complete follow up consultations

Who cannot join

Earlier or present infection of the hip
Severe systemic or metabolic disease leading to weakening of the bone
Severe congenital hip dysplasia
Osteoporosis and/or renal disease

About this study

Official title: Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing - A Randomized Controlled Trial With 5-years Follow up Including 75 Patients

Read the detailed description

The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the 21st century. Subsequently reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions.

This was a single center parallel-group randomized controlled trial. The primary outcome was to compare Cr and Co concentrations at 5-years follow up following MoM-LDH total hip arthroplasty (MoM-LDH-THA) or MoM-LDH hip resurfacing (MoM-LDH-HR).

Secondary outcomes were radiological findings, patient reported outcome measures and revision rate at 5-years follow up.

The study was prematurely terminated in 2012 due to alerts and safety communications from the Danish national regulatory agency regarding early failure rates and high incidence of ARMD in patients with MoM hip implants [13]. At that time the study population consisted of 75 patients out of 200 planned for inclusion.

Conditions: Osteoarthritis, Hip
Being tested: Magnum, Zimmer Biomet, Warsaw, IN, Recap, Zimmer Biomet, Warsaw, IN
Keywords: Metal ion concentration, Total hip arthroplasty, Hip resurfacing
Medical subject headings: Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnum, Zimmer Biomet, Warsaw, INDevice
Recap, Zimmer Biomet, Warsaw, INDevice

Study groups in NCT04585022
Study group	Role	What they receive
Magnum	Active comparator	A metal-on-metal large diameter head total hip arthroplasty Receives: Device: Magnum, Zimmer Biomet, Warsaw, IN
Recap	Active comparator	A metal-on-metal hip resurfacing arthroplasty Receives: Device: Recap, Zimmer Biomet, Warsaw, IN

What is being measured

The primary outcome is the main question the study is designed to answer.

Metal Ion Concentrations in Blood
Chromium and cobalt concentrations in whole blood
Measured: at 5 years follow up

Secondary outcomes (3)

Harris Hip Score
Harris Hip Score (0-100, higher values meaning better outcome)
Measured: at 5 years follow up
SF-36
Short Form 36 Health Survey Questionnaire (SF-36) (0-100, higher values meaning better outcome)
Measured: at 5 years follow up
Number of Patients Undergoing Revision
Rate of revision during the follow-up period, calculated as number of revisions (numerator) out of the total number of patients starting the study (denominator)
Measured: at 5 years follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 200611 Jan 2017

First posted14 Oct 2020
Study start1 Nov 2006
Primary completion11 Jan 2017
Study completion11 Jan 2017

Why it stopped: High early failure rates and adverse reactions in similar devices

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis, HipStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04585022
Sponsor's protocol ID: KF 01-309171
Status last verified: Mar 2023
First submitted: 23 Sep 2020
Last updated: 3 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: No IPD are to be shared with other researchers.

Publications

Schmalzried TP, Peters PC, Maurer BT, Bragdon CR, Harris WH. Long-duration metal-on-metal total hip arthroplasties with low wear of the articulating surfaces. J Arthroplasty. 1996 Apr;11(3):322-31. doi: 10.1016/s0883-5403(96)80085-4.
PubMed 8713913
Chan FW, Bobyn JD, Medley JB, Krygier JJ, Tanzer M. The Otto Aufranc Award. Wear and lubrication of metal-on-metal hip implants. Clin Orthop Relat Res. 1999 Dec;(369):10-24. doi: 10.1097/00003086-199912000-00003.
PubMed 10611857
Cuckler JM, Moore KD, Lombardi AV Jr, McPherson E, Emerson R. Large versus small femoral heads in metal-on-metal total hip arthroplasty. J Arthroplasty. 2004 Dec;19(8 Suppl 3):41-4. doi: 10.1016/j.arth.2004.09.006.
PubMed 15578551
Peters CL, McPherson E, Jackson JD, Erickson JA. Reduction in early dislocation rate with large-diameter femoral heads in primary total hip arthroplasty. J Arthroplasty. 2007 Sep;22(6 Suppl 2):140-4. doi: 10.1016/j.arth.2007.04.019. Epub 2007 Jul 27.
PubMed 17823033
Papageorgiou I, Yin Z, Ladon D, Baird D, Lewis AC, Sood A, Newson R, Learmonth ID, Case CP. Genotoxic effects of particles of surgical cobalt chrome alloy on human cells of different age in vitro. Mutat Res. 2007 Jun 1;619(1-2):45-58. doi: 10.1016/j.mrfmmm.2007.01.008. Epub 2007 Jan 25.
PubMed 17376492
Langton DJ, Joyce TJ, Jameson SS, Lord J, Van Orsouw M, Holland JP, Nargol AV, De Smet KA. Adverse reaction to metal debris following hip resurfacing: the influence of component type, orientation and volumetric wear. J Bone Joint Surg Br. 2011 Feb;93(2):164-71. doi: 10.1302/0301-620X.93B2.25099.
PubMed 21282753
Whitehouse MR, Aquilina AL, Patel S, Eastaugh-Waring SJ, Blom AW. Survivorship, patient reported outcome and satisfaction following resurfacing and total hip arthroplasty. J Arthroplasty. 2013 May;28(5):842-8. doi: 10.1016/j.arth.2013.01.007. Epub 2013 Mar 13.
PubMed 23489727
Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AV. Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: A consequence of excess wear. J Bone Joint Surg Br. 2010 Jan;92(1):38-46. doi: 10.1302/0301-620X.92B1.22770.
PubMed 20044676
Bozic KJ, Kurtz S, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of bearing surface usage in total hip arthroplasty in the United States. J Bone Joint Surg Am. 2009 Jul;91(7):1614-20. doi: 10.2106/JBJS.H.01220.
PubMed 19571083
Mahomed NN, Arndt DC, McGrory BJ, Harris WH. The Harris hip score: comparison of patient self-report with surgeon assessment. J Arthroplasty. 2001 Aug;16(5):575-80. doi: 10.1054/arth.2001.23716.
PubMed 11503116
DeLee JG, Charnley J. Radiological demarcation of cemented sockets in total hip replacement. Clin Orthop Relat Res. 1976 Nov-Dec;(121):20-32.
PubMed 991504
Gruen TA, McNeice GM, Amstutz HC. "Modes of failure" of cemented stem-type femoral components: a radiographic analysis of loosening. Clin Orthop Relat Res. 1979 Jun;(141):17-27.
PubMed 477100
Callanan MC, Jarrett B, Bragdon CR, Zurakowski D, Rubash HE, Freiberg AA, Malchau H. The John Charnley Award: risk factors for cup malpositioning: quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relat Res. 2011 Feb;469(2):319-29. doi: 10.1007/s11999-010-1487-1.
PubMed 20717858
Borgwardt A, Borgwardt L, Zerahn B, Daugaard H, Borgwardt L, Ribel-Madsen S. A Randomized Seven-Year Study on Performance of the Stemmed Metal M2a-Magnum and Ceramic C2a-Taper, and the Resurfacing ReCap Hip Implants. J Arthroplasty. 2018 May;33(5):1412-1420. doi: 10.1016/j.arth.2017.11.061. Epub 2017 Dec 5.
PubMed 29276121
Costa ML, Achten J, Parsons NR, Edlin RP, Foguet P, Prakash U, Griffin DR; Young Adult Hip Arthroplasty Team. Total hip arthroplasty versus resurfacing arthroplasty in the treatment of patients with arthritis of the hip joint: single centre, parallel group, assessor blinded, randomised controlled trial. BMJ. 2012 Apr 19;344:e2147. doi: 10.1136/bmj.e2147.
PubMed 22517930

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
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Hip Osteoarthritis, Hip Arthropathy

All Osteoarthritis, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing - A Randomized Controlled Trial With 5-years Follow up Including 75 Patients
ClinicalTrials.gov ID: NCT04585022
Acronym / sponsor ID: KF 01-309171
Conditions: Osteoarthritis, Hip
Keywords: Metal ion concentration, Total hip arthroplasty, Hip resurfacing
Study type: Interventional
Recruitment status: TerminatedReason stopped: High early failure rates and adverse reactions in similar devices
Enrolment: 75 participants (actual)
Lead sponsor: Hvidovre University HospitalUniversity, hospital or other
Study start: 1 Nov 2006 (actual)
Primary completion: 11 Jan 2017 (actual)
Study completion: 11 Jan 2017 (actual)
First posted: 14 Oct 2020 (actual)
Results: Posted 3 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Secondary outcomes were radiological findings, patient reported outcome measures and revision rate at 5-years follow up.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Magnum	Active comparator	Device: Magnum, Zimmer Biomet, Warsaw, INA metal-on-metal large diameter head total hip arthroplasty
Recap	Active comparator	Device: Recap, Zimmer Biomet, Warsaw, INA metal-on-metal hip resurfacing arthroplasty

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Primary or secondary hip osteoarthritis eligible for hip replacement surgery
Able to give informed consent
Able to complete follow up consultations

Key exclusion criteria (4 listed)

Earlier or present infection of the hip
Severe systemic or metabolic disease leading to weakening of the bone
Severe congenital hip dysplasia
Osteoporosis and/or renal disease

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
Magnum, Zimmer Biomet, Warsaw, IN	Device	Magnum
Recap, Zimmer Biomet, Warsaw, IN	Device	Recap

Primary outcome

Metal Ion Concentrations in Blood
Time frame: at 5 years follow up
Chromium and cobalt concentrations in whole blood

3 secondary outcomes

Harris Hip Score
Time frame: at 5 years follow up
SF-36
Time frame: at 5 years follow up
Number of Patients Undergoing Revision
Time frame: at 5 years follow up

Results and safety

Results posted to the registry on 3 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Magnum	39	33
Recap	36	25

Primary outcome: Metal Ion Concentrations in Blood

Time frame: at 5 years follow up. Median (Inter-Quartile Range). Unit: micrograms/liter

Measure	Magnum n = 25	Recap n = 20
Chromium	1.36 (0.99 to 3.11)	1.21 (0.88 to 3.03)
Cobalt	1.67 (0.86 to 2.31)	0.92 (0.64 to 1.49)

Population analysed: The discrepancy between numbers of patients analysed and the numbers presented in Participant flow is due to patients who had bilateral MoM hip replacement at the 5-year follow-up were excluded in addition to those lost to follow up, who had revision surgery or died before 5-years follow up.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Magnum	0 of 39 (0%)	0 of 39 (0%)	2 of 39
Recap	6 of 36 (16.7%)	0 of 36 (0%)	0 of 36

Limitations and caveats (from the sponsor): Due to a revision rate of 16.7% in the MoM-HR group and lost at follow up (15.4% and 13.9% for MoM-LDH-THA and MoM-HR respectively) in both groups data were not complete. No preoperative data were obtained for our primary or secondary outcomes. Due to premature termination of the study it lacks power causing a risk of type II error.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8713913Schmalzried TP, Peters PC, Maurer BT, Bragdon CR, Harris WH. Long-duration metal-on-metal total hip arthroplasties with low wear of the articulating surfaces. J Arthroplasty. 1996 Apr;11(3):322-31. doi: 10.1016/s0883-5403(96)80085-4.
Background: PubMed 10611857Chan FW, Bobyn JD, Medley JB, Krygier JJ, Tanzer M. The Otto Aufranc Award. Wear and lubrication of metal-on-metal hip implants. Clin Orthop Relat Res. 1999 Dec;(369):10-24. doi: 10.1097/00003086-199912000-00003.
Background: PubMed 15578551Cuckler JM, Moore KD, Lombardi AV Jr, McPherson E, Emerson R. Large versus small femoral heads in metal-on-metal total hip arthroplasty. J Arthroplasty. 2004 Dec;19(8 Suppl 3):41-4. doi: 10.1016/j.arth.2004.09.006.
Background: PubMed 17823033Peters CL, McPherson E, Jackson JD, Erickson JA. Reduction in early dislocation rate with large-diameter femoral heads in primary total hip arthroplasty. J Arthroplasty. 2007 Sep;22(6 Suppl 2):140-4. doi: 10.1016/j.arth.2007.04.019. Epub 2007 Jul 27.
Background: PubMed 17376492Papageorgiou I, Yin Z, Ladon D, Baird D, Lewis AC, Sood A, Newson R, Learmonth ID, Case CP. Genotoxic effects of particles of surgical cobalt chrome alloy on human cells of different age in vitro. Mutat Res. 2007 Jun 1;619(1-2):45-58. doi: 10.1016/j.mrfmmm.2007.01.008. Epub 2007 Jan 25.
Background: PubMed 21282753Langton DJ, Joyce TJ, Jameson SS, Lord J, Van Orsouw M, Holland JP, Nargol AV, De Smet KA. Adverse reaction to metal debris following hip resurfacing: the influence of component type, orientation and volumetric wear. J Bone Joint Surg Br. 2011 Feb;93(2):164-71. doi: 10.1302/0301-620X.93B2.25099.
Background: PubMed 23489727Whitehouse MR, Aquilina AL, Patel S, Eastaugh-Waring SJ, Blom AW. Survivorship, patient reported outcome and satisfaction following resurfacing and total hip arthroplasty. J Arthroplasty. 2013 May;28(5):842-8. doi: 10.1016/j.arth.2013.01.007. Epub 2013 Mar 13.
Background: PubMed 20044676Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AV. Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: A consequence of excess wear. J Bone Joint Surg Br. 2010 Jan;92(1):38-46. doi: 10.1302/0301-620X.92B1.22770.
Background: PubMed 19571083Bozic KJ, Kurtz S, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of bearing surface usage in total hip arthroplasty in the United States. J Bone Joint Surg Am. 2009 Jul;91(7):1614-20. doi: 10.2106/JBJS.H.01220.
Background: PubMed 11503116Mahomed NN, Arndt DC, McGrory BJ, Harris WH. The Harris hip score: comparison of patient self-report with surgeon assessment. J Arthroplasty. 2001 Aug;16(5):575-80. doi: 10.1054/arth.2001.23716.
Background: PubMed 991504DeLee JG, Charnley J. Radiological demarcation of cemented sockets in total hip replacement. Clin Orthop Relat Res. 1976 Nov-Dec;(121):20-32.
Background: PubMed 477100Gruen TA, McNeice GM, Amstutz HC. "Modes of failure" of cemented stem-type femoral components: a radiographic analysis of loosening. Clin Orthop Relat Res. 1979 Jun;(141):17-27.
Individual participant dataSharing planned: No. No IPD are to be shared with other researchers.

Related trials for Osteoarthritis, Hip

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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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.

Anders Troelsen, MD principal investigator

Hvidovre University Hospital

Questions about this trial

What is this clinical trial studying?

A study testing Magnum, Zimmer Biomet, Warsaw, IN and Recap, Zimmer Biomet, Warsaw, IN in people with Osteoarthritis, Hip, run by Hvidovre University Hospital.

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 4 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: stopped early, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 3 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Metal Ion Concentrations in Blood (time frame: at 5 years follow up). 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 NCT04585022, which also lists 26 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 3 Mar 2023.