Revision of ADR to a NEW ADR

[cavalier]

Revision of a Charité artificial disc 9.5 years in vivo to a new Charité artificial disc: case report and explant analysis

JournalEuropean Spine JournalPublisherSpringer Berlin / HeidelbergISSN0940-6719 (Print) 1432-0932 (Online)IssueVolume 14, Number 5 / June, 2005CategoryCase ReportDOI10.1007/s00586-004-0842-xPages507-511Subject CollectionMedicineSpringerLink DateWednesday, January 26, 2005
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Case Report

Revision of a Charité artificial disc 9.5 years in vivo to a new Charité artificial disc: case report and explant analysis
Thierry David1
(1) Polyclinique de Bois-Bernard, Route De Neuvireuil Bois/Benard, 62320 Bois-Bernard, FranceReceived: 25 August 2004 Accepted: 11 October 2004 Published online: 26 January 2005
Abstract This report describes a case of one-level total disc replacement (TDR) of L5-S1 requiring revision at 9.5 years following the index surgery due to polyethylene failure caused by high oxidation. Primary revision strategies for TDR include instrumented posterolateral fusion, or 360° fusion with replacement of the prosthesis with cages or allograft bone. A revision of a TDR with a similar prosthesis has not been described in the literature. An active 42-year-old female underwent TDR with a Charité artificial disc. She remained active and pain free for 9.5 years before presenting with moderate low-back pain and sciatica. Radiographic studies confirmed a fragmented polyethylene core. The failed prosthesis was revised to a new Charité disc with the patient again active and pain free for 6 months following surgery. Chemical and physical analysis of the core indicated high oxidation due to gamma sterilization in air; a process changed to gamma sterilization in nitrogen in 1998 to meet industry standards. No evidence of wear debris was noted. Revision of an artificial disc with an artificial disc can be performed safely and adequately with the Charité disc prosthesis as an alternative to fusion necessitated by a device failure. An anterior revision approach carries significant risk and should only be performed by surgeons experienced in anterior lumbar surgery.
Keywords Lumbar spine - Artificial disc - Revision

Thierry David
Email: t.david@voila.fr
Phone: +33-321-792656
Fax: +33-321-792780
http://www.springerlink.com/content/k5hhedmu9rehuv22/

I thuoght it was important to post this as this was a 9/12 yr invivo implant that started to wear so people know it is possible to have another ADR - of course the best surgeon skills are a important factor but to know of cases where it has been done. - as our ADR's age it is good to know in case - Jill

[Katie]

Thanks for that Jill. I wonder if Charite paid for the revision since it was a failure of their product? I'd like to know the details, how much longer the revision took, etc.

It is very encouraging to hear of this success. Have you come across any studies of how many polyethylene cores have deteriorated? I'm trying to decide which disc to go with now. Justin put out a study that reported metal wear from the Maverick, but I've heard there are lots about the poly as well.

[cavalier]

Katie I just posted a study done only on the Charite but it is the 1st examining long term wear of the core & the endplates - it has it's own thread - I just sent it - it is a long read but one WORTH reading. It does show some patterns & it gets into all of that. - noting is as perfect as what we had WHEN it used to function properly of course.

Jill

[Katie]

Jill, where did you put it?

[Katie]

Never mind, found it!

[KBear]

Is this saying they just replaced the polyurethane and not the endplates? That's how I read it; but wanted to double check that.

[Justin]

Thanks for that Jill. I wonder if Charite paid for the revision since it was a failure of their product? I'd like to know the details, how much longer the revision took, etc.

It is very encouraging to hear of this success. Have you come across any studies of how many polyethylene cores have deteriorated? I'm trying to decide which disc to go with now. Justin put out a study that reported metal wear from the Maverick, but I've heard there are lots about the poly as well.

There is no mention of Charite paying for a new device in the fulltext publication. I don't think they would even consider that at almost 10 years post-op. The publication does not state how long the revision operation took.

In regard to the polyethylene core wear, there is a study about the Charite. (Here's a link to an artificial disc wear analysis thread that includes Charite wear analysis.) I haven't found a study on ProDisc yet. I don't know if there are "lots" of wear from the UHMWPE, but there have been studies to document wear similar to the Maverick metal-on-metal wear.

Is this saying they just replaced the polyurethane and not the endplates? That's how I read it; but wanted to double check that.

Kathy, they replaced both the polyethylene core (UHMWPE) and the endplates. The endplates were noted to be in their original position.