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

Osteoarthritis, Hip Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04585022
• Other study ID #: KF 01-309171
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2006
• Est. completion date: January 11, 2017

Study information

• Verified date: March 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 up.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: January 11, 2017
• Est. primary completion date: January 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Device:
• Magnum, Zimmer Biomet, Warsaw, IN

• Recap, Zimmer Biomet, Warsaw, IN

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

References & Publications (25)

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Hutt J, Lavigne M, Lungu E, Belzile E, Morin F, Vendittoli PA. Comparison of Whole-Blood Metal Ion Levels Among Four Types of Large-Head, Metal-on-Metal Total Hip Arthroplasty Implants: A Concise Follow-up, at Five Years, of a Previous Report. J Bone Joint Surg Am. 2016 Feb 17;98(4):257-66. doi: 10.2106/JBJS.O.00201. — View Citation

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Jantzen C, Jorgensen HL, Duus BR, Sporring SL, Lauritzen JB. Chromium and cobalt ion concentrations in blood and serum following various types of metal-on-metal hip arthroplasties: a literature overview. Acta Orthop. 2013 Jun;84(3):229-36. doi: 10.3109/17453674.2013.792034. Epub 2013 Apr 18. — View Citation

Junnila M, Kostensalo I, Virolainen P, Remes V, Matilainen M, Vahlberg T, Pulkkinen P, Eskelinen A, Itala A, Makela K. Hip resurfacing arthroplasty versus large-diameter head metal-on-metal total hip arthroplasty: comparison of three designs from the Finnish Arthroplasty Register. Scand J Surg. 2014 Mar;103(1):54-9. doi: 10.1177/1457496913495345. Epub 2013 Dec 17. — View Citation

Khan M, Kuiper JH, Sieniawska C, Richardson JB. Differences in concentration of metal debris in blood, serum, and plasma samples of patients with metal-on-metal hip resurfacing arthroplasty. J Orthop. 2015 Dec 9;13(4):450-454. doi: 10.1016/j.jor.2015.10.006. eCollection 2016 Dec. — View Citation

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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. Erratum In: J Bone Joint Surg Br. 2011 Apr;93(4):566. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Renner L, Faschingbauer M, Schmidt-Braekling T, Boettner F. Cobalt serum levels differ in well functioning Birmingham resurfacing and Birmingham modular THA. Arch Orthop Trauma Surg. 2016 May;136(5):715-21. doi: 10.1007/s00402-016-2439-3. Epub 2016 Mar 16. — View Citation

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. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metal Ion Concentrations in Blood	Chromium and cobalt concentrations in whole blood	at 5 years follow up
Secondary	Harris Hip Score	Harris Hip Score (0-100, higher values meaning better outcome)	at 5 years follow up
Secondary	SF-36	Short Form 36 Health Survey Questionnaire (SF-36) (0-100, higher values meaning better outcome)	at 5 years follow up
Secondary	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)	at 5 years follow up