Spinal DiseasesPDLNCT00295009

Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery

A study testing ProDisc and Spinal Fusion in people with Spinal Diseases, run by Synthes USA HQ, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with DDD in the lumbosacral spine. There will be separate study arms for one and two level cases. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Spinal Diseases
What is being tested?: ProDisc and Spinal Fusion
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 852 participants
Where: No sites listed yet
Study dates: Sep 2001to Apr 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Degenerative Disc Disease (DDD) in one or two adjacent vertebral levels between L3 and S1. Diagnosis of DDD requires: a)Back and/or leg (radicular) pain; and b)Radiographic confirmation of any 1 of the following by CT, MRI, discography, plain film, myelography and/or flexion/extension films: Instability (greater than or equal to 3mm translation or 5° angulation); Decreased disc height >2mm; Scarring/thickening of annulus fibrosis; Herniated nucleus pulposus; or Vacuum phenomenon.
Age between 18 and 60 years.
Failed at least 6 months of conservative treatment.
Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%)(Interpreted as moderate/severe disability).
Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
Signed informed consent.

Who cannot join

No more than 2 vertebral levels may have DDD and all diseased levels, either one or two, must be treated.
Patients with involved vertebral endplates dimensionally smaller than 34.5mm in the medial-lateral and/or 27mm in the anterior-posterior directions.
Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum.
Prior fusion surgery at any vertebral level.
Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma.
Radiographic confirmation of facet joint disease or degeneration.

Show all 19Show fewer

Lytic spondylolisthesis or spinal stenosis.
Degenerative spondylolisthesis of grade >1.
Back or leg pain of unknown etiology.
Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients to determine if a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than
1.0. The World Health Organization defines osteoporosis as a DEXA T score less than or equal to -2.5.
Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
Morbid obesity defined as a body mass index >40 or a weight more than 100 lbs. over ideal body weight.
Pregnant or interested in becoming pregnant in the next 3 years.
Active infection - systemic or local.
Taking medication or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
Rheumatoid arthritis or other autoimmune disease.
Systemic disease including AIDS, HIV, Hepatitis.
Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years.

About this study

Official title: A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc to Spinal Fusion Surgery in the Treatment of Discogenic Pain Associated With DDD in the Lumbosacral Spine

Conditions: Spinal Diseases
Being tested: ProDisc, Spinal Fusion
Medical subject headings: Spinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ProDiscDevice
Total disc replacement with ProDisc
Spinal FusionProcedure or surgery
A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.

Study groups in NCT00295009
Study group	Role	What they receive
1-Level Fusion	Active comparator	Spinal fusion at a single lumbar level. Receives: Procedure: Spinal Fusion
1-Level ProDisc	Experimental	Total disc replacement with the ProDisc device at one spinal lumbar level. Receives: Device: ProDisc
2-Level Fusion	Active comparator	Spinal fusion at two adjacent lumbar levels. Receives: Procedure: Spinal Fusion
2-Level ProDisc	Experimental	Total disc replacement with the ProDisc device at two adjacent lumbar levels. Receives: Device: ProDisc
1-level ProDisc (non-randomized)	Experimental	Total disc replacement with the ProDisc device for non-randomized subjects at one spinal lumbar level. Receives: Device: ProDisc
2-Level ProDisc (Continued Access)	Active comparator	Total disc replacement with the ProDisc device for non-randomized subjects at two spinal lumbar levels (only followed out to 24 months) Receives: Device: ProDisc

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Success
Overall success was a composite endpoint.
A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:
1. ODI score improved by at least 15% from baseline;
2. SF-36 score improved from baseline;
3. Neurologic parameters maintained or improved from baseline;
4. No re-operations to modify or remove the implant; and
5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.
A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:
1. Same as above
2. Same as above
3. Same as above
4. No re-operations to modify the fusion site or correct a complication with an implant; and
5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies
Measured: 24 Months
Overall Success
Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:
1. ODI score improved by at least 15% from baseline;
2. SF-36 score improved from baseline;
3. Neurologic parameters maintained or improved from baseline;
4. No re-operations required to modify or remove the implant; and
5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.
A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:
Items numbered 1-3, above; 4. No re-operations required to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies
Measured: 60 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2001Apr 2011

First posted22 Feb 2006 (estimated)
Study startSep 2001
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Spinal DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 852 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00295009
Sponsor's protocol ID: PDL-07272001
Acronym: PDL
Status last verified: Jul 2014
First submitted: 20 Feb 2006
Last updated: 6 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. J Neurosurg Spine. 2012 Dec;17(6):504-11. doi: 10.3171/2012.9.SPINE11717. Epub 2012 Oct 19.
PubMed 23082849

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Spinal Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc to Spinal Fusion Surgery in the Treatment of Discogenic Pain Associated With DDD in the Lumbosacral Spine
ClinicalTrials.gov ID: NCT00295009
Acronym / sponsor ID: PDL / PDL-07272001
Conditions: Spinal Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 852 participants (actual)
Lead sponsor: Synthes USA HQ, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2001
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 22 Feb 2006 (estimated)
Results: Posted 1 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
1-Level Fusion	Active comparator	Procedure: Spinal FusionSpinal fusion at a single lumbar level.
1-Level ProDisc	Experimental	Device: ProDiscTotal disc replacement with the ProDisc device at one spinal lumbar level.
2-Level Fusion	Active comparator	Procedure: Spinal FusionSpinal fusion at two adjacent lumbar levels.
2-Level ProDisc	Experimental	Device: ProDiscTotal disc replacement with the ProDisc device at two adjacent lumbar levels.
1-level ProDisc (non-randomized)	Experimental	Device: ProDiscTotal disc replacement with the ProDisc device for non-randomized subjects at one spinal lumbar level.
2-Level ProDisc (Continued Access)	Active comparator	Device: ProDiscTotal disc replacement with the ProDisc device for non-randomized subjects at two spinal lumbar levels (only followed out to 24 months)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Degenerative Disc Disease (DDD) in one or two adjacent vertebral levels between L3 and S1. Diagnosis of DDD requires: a)Back and/or leg (radicular) pain; and b)Radiographic confirmation of any 1 of the following by CT, MRI, discography, plain film, myelography and/or flexion/extension films: Instability (greater than or equal to 3mm translation or 5° angulation); Decreased disc height >2mm; Scarring/thickening of annulus fibrosis; Herniated nucleus pulposus; or Vacuum phenomenon.
Age between 18 and 60 years.
Failed at least 6 months of conservative treatment.
Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%)(Interpreted as moderate/severe disability).
Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.

Key exclusion criteria (19 listed)

No more than 2 vertebral levels may have DDD and all diseased levels, either one or two, must be treated.
Patients with involved vertebral endplates dimensionally smaller than 34.5mm in the medial-lateral and/or 27mm in the anterior-posterior directions.
Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum.
Prior fusion surgery at any vertebral level.
Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ProDiscTotal disc replacement with ProDisc	Device	1-Level ProDisc, 1-level ProDisc (non-randomized), 2-Level ProDisc, 2-Level ProDisc (Continued Access)
Spinal FusionA circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.	Procedure or surgery	1-Level Fusion, 2-Level Fusion

Primary outcome

Overall Success
Time frame: 24 Months
Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met: 1. ODI score improved by at least 15% from baseline; 2. SF-36 score improved from baseline; 3. Neurologic parameters maintained or improved from baseline; 4. No re-operations to modify or remove the implant; and 5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion. A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met: 1. Same as above 2. Same as above 3. Same as above 4. No re-operations to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies
Overall Success
Time frame: 60 Months
Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met: 1. ODI score improved by at least 15% from baseline; 2. SF-36 score improved from baseline; 3. Neurologic parameters maintained or improved from baseline; 4. No re-operations required to modify or remove the implant; and 5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion. A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met: Items numbered 1-3, above; 4. No re-operations required to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies

Results and safety

Results posted to the registry on 1 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1-Level Fusion	93	52
1-Level ProDisc	183	134
1-Level ProDisc (Non-Randomized)	51	39
2-Level Fusion	82	57
2-Level ProDisc	174	116
2-Level ProDisc (Continued Access)	269	0

Primary outcome: Overall Success

Time frame: 24 Months. Number. Unit: percentage of overall successes

Measure	1-Level Fusion n = 71	1-Level ProDisc n = 148	1-Level ProDisc (Non-randomized) n = 45	2-Level Fusion n = 60	2-Level ProDisc n = 133	2-Level ProDisc (Continued Access) n = 198
Value	45.1	63.5	66.7	53.3	59.4	58.6

Population analysed: Patients who completed all 24 month visit analyses

Primary outcome: Overall Success

Time frame: 60 Months. Number. Unit: percentage of overall successes

Measure	1-Level Fusion n = 52	1-Level ProDisc n = 134	1-Level ProDisc (Non-randomized) n = 39	2-Level Fusion n = 57	2-Level ProDisc n = 116	2-Level ProDisc (Continued Access) n = 0
Value	50.0	53.7	56.4	50.9	55.2	–

Population analysed: Patients who completed all 60 month visit analyses

Adverse events

Time frame: Adverse Events were collected at each visit through 60 month follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1-Level Fusion	27 of 80 (33.8%)	73 of 80 (91.3%)	Not reported
1-Level ProDisc	43 of 162 (26.5%)	153 of 162 (94.4%)	Not reported
1-Level ProDisc (Non-Randomized)	16 of 50 (32%)	46 of 50 (92%)	Not reported
2-Level Fusion	23 of 72 (31.9%)	69 of 72 (95.8%)	Not reported
2-Level ProDisc	39 of 165 (23.6%)	153 of 165 (92.7%)	Not reported
2-Level ProDisc (Continued Access)	38 of 259 (14.7%)	219 of 259 (84.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23082849Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. J Neurosurg Spine. 2012 Dec;17(6):504-11. doi: 10.3171/2012.9.SPINE11717. Epub 2012 Oct 19.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing ProDisc and Spinal Fusion in people with Spinal Diseases, run by Synthes USA HQ, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Success (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00295009, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.