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

NCT04585022 | Terminated Results

• 1 other identifier: KF 01-309171
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoarthritis, Hip

Keywords

Metal ion concentration; Total hip arthroplasty; Hip resurfacing

Outcome Measures

Primary Outcomes (1)

• Metal Ion Concentrations in Blood

  Chromium and cobalt concentrations in whole blood

  at 5 years follow up

Secondary Outcomes (3)

• Harris Hip Score

  at 5 years follow up

• SF-36

  at 5 years follow up

• Number of Patients Undergoing Revision

  at 5 years follow up

Study Arms (2)

Magnum

ACTIVE COMPARATOR

A metal-on-metal large diameter head total hip arthroplasty

Device: Magnum, Zimmer Biomet, Warsaw, IN

Recap

ACTIVE COMPARATOR

A metal-on-metal hip resurfacing arthroplasty

Device: Recap, Zimmer Biomet, Warsaw, IN

Interventions

Magnum, Zimmer Biomet, Warsaw, IN DEVICE

Magnum

Recap, Zimmer Biomet, Warsaw, IN DEVICE

Recap

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Related Publications (26)

• 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.

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• 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.

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• 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.

  PMID: 15578551 BACKGROUND

• 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.

  PMID: 17823033 BACKGROUND

• 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.

  PMID: 17376492 BACKGROUND

• 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.

  PMID: 21282753 BACKGROUND

• 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.

  PMID: 23489727 BACKGROUND

• 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.

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  PMID: 19571083 BACKGROUND

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  PMID: 11503116 BACKGROUND

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  PMID: 991504 BACKGROUND

• 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.

  PMID: 477100 BACKGROUND

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  PMID: 20717858 BACKGROUND

• 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.

  PMID: 29276121 BACKGROUND

• 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.

  PMID: 22517930 BACKGROUND

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  PMID: 19697090 BACKGROUND

• 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.

  PMID: 27857480 BACKGROUND

• 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.

  PMID: 23594249 BACKGROUND

• 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.

  PMID: 26983720 BACKGROUND

• 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.

  PMID: 26888673 BACKGROUND

• Jacobs 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.

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• Jack CM, Walter WL, Shimmin AJ, Cashman K, de Steiger RN. Large diameter metal on metal articulations. Comparison of total hip arthroplasty and hip resurfacing arthroplasty. J Arthroplasty. 2013 Apr;28(4):650-3. doi: 10.1016/j.arth.2012.07.032. Epub 2012 Nov 7.

  PMID: 23140992 BACKGROUND

• Hersnaes PN, Gromov K, Otte KS, Gebuhr PH, Troelsen A. Harris Hip Score and SF-36 following metal-on-metal total hip arthroplasty and hip resurfacing - a randomized controlled trial with 5-years follow up including 75 patients. BMC Musculoskelet Disord. 2021 Sep 12;22(1):781. doi: 10.1186/s12891-021-04671-1.

  PMID: 34511090 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: MD Peter Nyby Hersnaes
• Organization: Copenhagen University Hospital Hvidovre, Orthopaedic Department

pnhersnaes@gmail.com

+45 40104845

Study Officials

• Anders Troelsen, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both the care provider and patient were blinded until day of surgery. The laboratory analyzing blood metal concentrations were blinded to treatment allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, dr.med., Professor

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 14, 2020
• Study Start: November 1, 2006
• Primary Completion: January 11, 2017
• Study Completion: January 11, 2017
• Last Updated: March 3, 2023
• Results First Posted: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share