Clinical trial NCT04585022: Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Metal ion concentration
Total hip arthroplasty
Hip resurfacing
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metal Ion Concentrations in Blood
timeFrame: at 5 years follow up
Secondary outcomes:
measure: Harris Hip Score
timeFrame: at 5 years follow up
measure: SF-36
timeFrame: at 5 years follow up
measure: Number of Patients Undergoing Revision
timeFrame: at 5 years follow up
Other outcomes:
Locations:
Study officials:
affiliation: Hvidovre University Hospital
name: Anders Troelsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: DeLee JG, Charnley J. Radiological demarcation of cemented sockets in total hip replacement. Clin Orthop Relat Res. 1976 Nov-Dec;(121):20-32.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Garbuz DS, Tanzer M, Greidanus NV, Masri BA, Duncan CP. The John Charnley Award: Metal-on-metal hip resurfacing versus large-diameter head metal-on-metal total hip arthroplasty: a randomized clinical trial. Clin Orthop Relat Res. 2010 Feb;468(2):318-25. doi: 10.1007/s11999-009-1029-x. Epub 2009 Aug 21.
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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: Berstock JR, Whitehouse MR, Duncan CP. Trunnion corrosion: what surgeons need to know in 2018. Bone Joint J. 2018 Jan;100-B(1 Supple A):44-49. doi: 10.1302/0301-620X.100B1.BJJ-2017-0569.R1.
citation: Varnum C, Pedersen AB, Makela K, Eskelinen A, Havelin LI, Furnes O, Karrholm J, Garellick G, Overgaard S. Increased risk of revision of cementless stemmed total hip arthroplasty with metal-on-metal bearings. Acta Orthop. 2015;86(4):469-76. doi: 10.3109/17453674.2015.1023132. Epub 2015 Feb 26.
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.
citation: 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.
citation: 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.