[Artificial Disc Replacement] Results and Analysis of Compassionate Use of Lumbar Disc Replacements (4yr Follow-up)

[Justin]

The Spine Journal
Volume 8, Issue 5, Supplement 1, September-October 2008, Pages 159S-160S
Proceedings of the 23rd Annual Meeting of the North American Spine Society, NASS 24th Annual Meeting

Results and Analysis of Compassionate Use of Lumbar Disc Replacements Up to Four Year Follow-up

Robert Tatsumi MD1, Jason Gallina MD2, L.E.A. Kanim MA, PhD2, Hyun W. Bae MD2, Michael Kropf MD2 and Rick Delamarter MD1

1The Spine Institute, Santa Monica, CA, USA
2Santa Monica, CA, USA

BACKGROUND CONTEXT: Lumbar degenerative disc disease is universal and spinal fusion has been the traditional surgical gold standard treatment for intractable pain due to degenerative disc disease. Concerns with fusion morbidity, prolonged recovery and accelerated adjacent segment degeneration have led researchers to develop motion-preserving artificial disc replacement (ADR) as alternative to fusion. ProDisc-L™ (Synthes Spine, West Chester, PA) is an ADR that has been approved by the FDA with recent prospective randomized control trial (PRCT) documented results demonstrating superior outcomes in one level ADR patients compared with circumferential fusion.

PURPOSE: To evaluate outcome and radiographic data in patients implanted because they did not meet eligibility criteria for the ProDisc-L PRCT. These patients received ProDisc-L under the compassionate use exemption by the FDA.

STUDY DESIGN/ SETTING: Prospective clinical trial evaluating patients implanted with the ProDisc-L on a compassionate use exemption with clinical and radiologic follow-up at at 6 weeks, 3 months, 6 months, and annually.

PATIENT SAMPLE: Forty patients with lumbar disc degeneration with radicular pain who were excluded from ProDisc-L RCT were offered ProDisc-L under the compassionate use exemption. Reasons for ineligibility included 3 level disc degeneration (27), severe facet arthrosis (6), prior lumbar fusion (4), >50% facet resected (1), severe central stenosis (1), and age >60 y/o (1).

OUTCOME MEASURES: Patients completed Oswestry Disability Index (ODI), Visual Analogue Scale pain (VAS-pain), Visual Analogue Scale Satisfaction (VAS-Sat) and answered the question “would you have surgery again?” at the scheduled follow-up visits.

METHODS: In addition to outcome measurements, radiographs and physical assessments were performed at each scheduled visit. Changes from pre-operative pain and disability and overall satisfaction were separately evaluated as a function of treatment using repeated measures mixed design analysis of variance.

RESULTS: Forty patients underwent ProDisc-L. The mean age was 45 years old, 52% of the patients were male, and 15% of the patients were smokers. Three patients had 1-level ProDisc-L (ADR-1), 10 patients had two-level ProDisc-L (ADR-2) and 27 patients had 3-level ProDisc-L (ADR-3). Follow up was 2–4 years . At 24 months, all patients had a significant reduction in ODI and VAS-pain scores, improved VAS-satisfaction scores and >75% of the patients stated they would definitely “have surgery again.” The ADR-3 patients had the greatest ODI improvement (25.7 points) and the ADR-1 patients had the greatest VAS pain improvement (5.3 points) and had the highest VAS-satisfaction scores (6.6cm). One patient required prothesis removal and fusion secondary to pain.

CONCLUSIONS: Patients who did not meet the strict criteria for the ProDisc-L PRCT but still received the device under the compassionate allowance were highly satisfied, had decreased pain, and had improved functional outcomes. ADR-1 patients had the highest pain relief and satisfaction scores and ADR-3 patients achieved the best improvement in disability. There was no statistical difference in outcomes scores between compassionate use ProDisc-L patients and the published RCT ProDisc-L patients. These results demonstrate “non-ideal” patients benefit from ProDisc-L and have similar functional and disability outcomes to the published RCT Pro-Disc patient cohort.

FDA DEVICE/DRUG STATUS: ProDisc-L: Investigational/Not approved.

Copyright © 2008 Elsevier Inc. All rights reserved.

[Justin]

Bumping this up for a Member.

[helmut]

The Spine Journal
Volume 8, Issue 5, Supplement 1, September-October 2008, Pages 159S-160S
Proceedings of the 23rd Annual Meeting of the North American Spine Society, NASS 24th Annual Meeting

Results and Analysis of Compassionate Use of Lumbar Disc Replacements Up to Four Year Follow-up

Robert Tatsumi MD1, Jason Gallina MD2, L.E.A. Kanim MA, PhD2, Hyun W. Bae MD2, Michael Kropf MD2 and Rick Delamarter MD1

1The Spine Institute, Santa Monica, CA, USA
2Santa Monica, CA, USA

BACKGROUND CONTEXT: Lumbar degenerative disc disease is universal and spinal fusion has been the traditional surgical gold standard treatment for intractable pain due to degenerative disc disease. Concerns with fusion morbidity, prolonged recovery and accelerated adjacent segment degeneration have led researchers to develop motion-preserving artificial disc replacement (ADR) as alternative to fusion. ProDisc-L™ (Synthes Spine, West Chester, PA) is an ADR that has been approved by the FDA with recent prospective randomized control trial (PRCT) documented results demonstrating superior outcomes in one level ADR patients compared with circumferential fusion.

PURPOSE: To evaluate outcome and radiographic data in patients implanted because they did not meet eligibility criteria for the ProDisc-L PRCT. These patients received ProDisc-L under the compassionate use exemption by the FDA.

STUDY DESIGN/ SETTING: Prospective clinical trial evaluating patients implanted with the ProDisc-L on a compassionate use exemption with clinical and radiologic follow-up at at 6 weeks, 3 months, 6 months, and annually.

PATIENT SAMPLE: Forty patients with lumbar disc degeneration with radicular pain who were excluded from ProDisc-L RCT were offered ProDisc-L under the compassionate use exemption. Reasons for ineligibility included 3 level disc degeneration (27), severe facet arthrosis (6), prior lumbar fusion (4), >50% facet resected (1), severe central stenosis (1), and age >60 y/o (1).

OUTCOME MEASURES: Patients completed Oswestry Disability Index (ODI), Visual Analogue Scale pain (VAS-pain), Visual Analogue Scale Satisfaction (VAS-Sat) and answered the question “would you have surgery again?” at the scheduled follow-up visits.

METHODS: In addition to outcome measurements, radiographs and physical assessments were performed at each scheduled visit. Changes from pre-operative pain and disability and overall satisfaction were separately evaluated as a function of treatment using repeated measures mixed design analysis of variance.

RESULTS: Forty patients underwent ProDisc-L. The mean age was 45 years old, 52% of the patients were male, and 15% of the patients were smokers. Three patients had 1-level ProDisc-L (ADR-1), 10 patients had two-level ProDisc-L (ADR-2) and 27 patients had 3-level ProDisc-L (ADR-3). Follow up was 2–4 years . At 24 months, all patients had a significant reduction in ODI and VAS-pain scores, improved VAS-satisfaction scores and >75% of the patients stated they would definitely “have surgery again.” The ADR-3 patients had the greatest ODI improvement (25.7 points) and the ADR-1 patients had the greatest VAS pain improvement (5.3 points) and had the highest VAS-satisfaction scores (6.6cm). One patient required prothesis removal and fusion secondary to pain.

CONCLUSIONS: Patients who did not meet the strict criteria for the ProDisc-L PRCT but still received the device under the compassionate allowance were highly satisfied, had decreased pain, and had improved functional outcomes. ADR-1 patients had the highest pain relief and satisfaction scores and ADR-3 patients achieved the best improvement in disability. There was no statistical difference in outcomes scores between compassionate use ProDisc-L patients and the published RCT ProDisc-L patients. These results demonstrate “non-ideal” patients benefit from ProDisc-L and have similar functional and disability outcomes to the published RCT Pro-Disc patient cohort.

FDA DEVICE/DRUG STATUS: ProDisc-L: Investigational/Not approved.

Copyright © 2008 Elsevier Inc. All rights reserved.

Fourty patients? I guess this study was done in 2008 so its been a while. Do American studies usually not include all the thousands of ADR implants that have been done in europe?

[Justin]

Fourty patients? I guess this study was done in 2008 so its been a while. Do American studies usually not include all the thousands of ADR implants that have been done in europe?

Hey Helmut, Artificial Disc Replacement studies performed in the United States do not include European Spine Patients, and are based on inclusion & exclusion criteria established by the FDA.

This is from the abstract above: these patients received ProDisc-L under the compassionate use exemption by the FDA.

[helmut]

Hey Helmut, Artificial Disc Replacement studies performed in the United States do not include European Spine Patients, and are based on inclusion & exclusion criteria established by the FDA.

This is from the abstract above: these patients received ProDisc-L under the compassionate use exemption by the FDA.

Thanks for clarifying Justin, I kind of figured that they don't include european statistics.
I guess they don't mind looking into cases from other countries when the foreign population has been used as guinea pigs like the south american population that has been infected on purpose with STD's etc. but then years later the president apologizes, so its all good.

"Compassionate use exemption" ... sounds heartwarming, or does it have a touch of arrogance?

[Jack-of-all-trades]

-80

Thanks for clarifying Justin, I kind of figured that they don't include european statistics.
I guess they don't mind looking into cases from other countries when the foreign population has been used as guinea pigs like the south american population that has been infected on purpose with STD's etc. but then years later the president apologizes, so its all good.

"Compassionate use exemption" ... sounds heartwarming, or does it have a touch of arrogance?

The STD thing was 60-80 years ago and dealt with the effective use of penicillin to treat syphilis. It is not like penicillin had not been used on people before. If I would have had syphilis 60 years ago when the effective treatment was poison I would have been first in line for the penicillin experiment. There was a lot of stuff done 60+ years ago that is considered a societal no-no now.

My observation has been the FDA is a lot more anal about introducing a prosthetic device used inside the body than in some other countries. Take LDR, the first studies involve the cream of the crop of bad discs. Like one level disease, no one over age 60 and other restrictions that are commonly waved in other countries.

This would be an area where the pharmacy suppliers could save a lot of money, that being having one standard, maybe under the auspices of the World Health Organization.

STUDY IN QUESTION

I suspect, given the positive results early on current procedures would have curtailed the study and treated everyone.

Tuskegee syphilis study
Main article: Tuskegee syphilis experiment
One of the best-documented US cases of unethical human medical experimentation in the twentieth century was the Tuskegee syphilis study. The study took place in Tuskegee, Alabama, and was supported by the U.S. Public Health Service (PHS) in partnership with the Tuskegee Institute.[14]

This section duplicates, in whole or part, the scope of other article(s) or section(s).
Please discuss this issue on the talk page and conform with Wikipedia's Manual of Style by replacing the section with a link and a summary of the repeated material, or by spinning off the repeated text into an article in its own right.
The study began in 1932, when syphilis was a widespread problem, especially in poor communities, and when there was no effective treatment or cure. Study researchers recruited a group of 600 black male sharecroppers in the rural area of Tuskegee, Alabama. Of these 600, 399 of the men had the disease in the latent, asymptomatic stage. 201 men were uninfected control patients. The PHS intended to study the progress of the disease and the effects of current treatments at different stages. Available treatments had such severe side effects that doctors questioned whether treatment provided the best outcome for the patient, or whether a man might do as well with no treatment. Patients were misled about the diagnosis of their disease, and about aspects of treatment, such as a painful lumbar puncture for evaluation. During the crisis of the Great Depression, in a segregated state with underfunded services for blacks, patients were recruited in exchange for physical exams, free health care of minor illnesses, free meals and transportation the day of exams, and a $50 death benefit. The study was designed to measure the progression of untreated syphilis. It also was to determine whether syphilis caused cardiovascular damage more often than neurological damage, as untreated disease led to effects in numerous body systems. Researchers hoped to determine whether the natural course of the disease was different in black men versus white men; historically, researchers had by then accumulated more information on the disease in white men.
By 1947 penicillin had been validated as an effective cure for syphilis and was becoming widely used by doctors and public health centers to treat the disease. PHS study directors continued the study, denying patients treatment by penicillin, and actively discouraging them from having penicillin administered by other sources. The men were never advised that they had syphilis, nor were they offered a treatment including Salvarsan or the other arsenical drugs that were in use at the beginning of the study.[citation needed]
The original study was meant to study patients in phases, with treatment after six to nine months. It continued to follow the original members and their families for 40 years. The study ended in 1972, long after 40 wives and 19 children had been infected, and many men had died of syphilis. During the study, 28 men died directly from syphilis, and 100 from other complications. The study ended because a PHS scientist leaked information about it to the Washington Star.[citation needed]
Survivors and patients' families filed a class-action lawsuit against the federal government for the study. This lawsuit was settled out of court and the living subjects and their descendants were awarded a total of ten million dollars.[citation needed] After the settlement was awarded, the government passed the National Research Act, which required the government to review and approve all medical studies involving human subjects.STUDY in Question:

[helmut]

I was thinking of this "experiment"

President Obama this afternoon spoke with Guatemalan President Alvaro Colom to “express his deep regret” and “extend an apology to all those infected” following the revelation that the U.S. Public Health Service conducted a study from 1946 to 1948 in which near 700 prisoners, soldiers and patients with emotional and mental problems were purposefully infected with syphilis.

[KBear]

OMGosh- I thought you were bs'ing about the STD's, didn't realize that it really happened. Wow, unbelievable.

[helmut]

-80
There was a lot of stuff done 60+ years ago that is considered a societal no-no now.

You don't think that it would have been considered a "no no" back then as well?
For some reason I can not get myself to believe that the reason why nowadays the FDA is not interested in surgical outcomes from Europe regarding ADR's, is to protect the citizens of the USA.

[Jack-of-all-trades]

You don't think that it would have been considered a "no no" back then as well?
For some reason I can not get myself to believe that the reason why nowadays the FDA is not interested in surgical outcomes from Europe regarding ADR's, is to protect the citizens of the USA.

Not in many circles. Our mores in general were a lot different back then. That was the age before TVs when most people didn't have a telephone and a lot could not even read. I doubt many even heard about such experiments or were ambivilent about it. Even now there are things going on in sub-Sahara Africa that are just as bad. We hear about it on the new but there is no great outcry from humanity to stop it because it is still going on. The Europeans have done experiments on humans too.H-Net Reviews

I really think not accepting Europeans history on use of replacement discs has more to do with the litigious society of the US. Lawyers advertise every day trying to drum up business for class action suits. Everyone who has anything to do with medicine in the USA is in big time CYA mode.

And you were right about the experiment mentioned in the news brief. I hadn't heard it and jumped to the conclusion about it being the Tuskegee experiment. Me bad.