Safety and Effectiveness Study of Prodisc to Spinal Fusio... | NCT00295009

NCT00295009

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1-Level Fusion	Active Comparator	Spinal fusion at a single lumbar level.	Procedure: Spinal Fusion
1-Level ProDisc	Experimental	Total disc replacement with the ProDisc device at one spinal lumbar level.	Device: ProDisc
2-Level Fusion	Active Comparator	Spinal fusion at two adjacent lumbar levels.	Procedure: Spinal Fusion
2-Level ProDisc	Experimental	Total disc replacement with the ProDisc device at two adjacent lumbar levels.	Device: ProDisc
1-level ProDisc (non-randomized)	Experimental	Total disc replacement with the ProDisc device for non-randomized subjects at one spinal lumbar level.	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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ProDisc	Device	Total disc replacement with ProDisc	1-Level ProDisc 1-level ProDisc (non-randomized) 2-Level ProDisc 2-Level ProDisc (Continued Access)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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: ODI score improved by at least 15% from baseline; SF-36 score improved from baseline; Neurologic parameters maintained or improved from baseline; No re-operations to modify or remove the implant; and 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: Same as above Same as above Same as above No re-operations to modify the fusion site or correct a complication with an implant; and 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	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: ODI score improved by at least 15% from baseline; SF-36 score improved from baseline; Neurologic parameters maintained or improved from baseline; No re-operations required to modify or remove the implant; and 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	60 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

PubMed Identifier	Type	Citation	Retractions
23082849	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	1-Level Fusion	Circumferential fusion at a single lumbar level.
FG001	1-Level ProDisc	Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
FG002	1-Level ProDisc (Non-Randomized)	Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
FG003	2-Level Fusion	Circumferential fusion at two adjacent lumbar levels.
FG004	2-Level ProDisc	Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
FG005	2-Level ProDisc (Continued Access)	Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	1-Level Fusion	Circumferential fusion at a single lumbar level.
BG001	1-Level ProDisc	Total disc arthroplasty with the ProDisc device at one spinal lumbar level.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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:

ODI score improved by at least 15% from baseline;
SF-36 score improved from baseline;
Neurologic parameters maintained or improved from baseline;
No re-operations to modify or remove the implant; and
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:

Same as above
Same as above
Same as above
No re-operations to modify the fusion site or correct a complication with an implant; and
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

Patients who completed all 24 month visit analyses

Posted

Number

percentage of overall successes

24 Months

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1-Level Fusion	Circumferential fusion at a single lumbar level.

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

ID	Term
D001174	Arthrodesis
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

OG000	1-Level Fusion	Circumferential fusion at a single lumbar level.
OG001	1-Level ProDisc	Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
OG002	1-Level ProDisc (Non-randomized)	Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
OG003	2-Level Fusion	Circumferential fusion at two adjacent lumbar levels.
OG004	2-Level ProDisc	Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
OG005	2-Level ProDisc (Continued Access)	Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.