Degenerative Disc Disease
Conditions
Keywords
One or Two Level Degenerative Disc Disease
Brief summary
The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
Interventions
DEVICEHEALOS and Leopard Cage
Placement in interbody space
DEVICELeopard Cage and Autograft
Placement in the interbody space
Sponsors
DePuy Spine
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Persistent back and/or leg pain refractory to 6 months of non-surgical therapy * Male or female 18 to 70 years of age (inclusive) * Objective evidence of significant disc degeneration at one or two adjacent lumbar level(s) from L2/L3 to L5/S1
Exclusion criteria
* Significant disc degeneration at more than two adjacent levels * Greater than Grade II spondylolisthesis * Prior fusion surgery of the lumbar spine (prior discectomies and intradiscal electrothermal therapy \[IDET\] are allowed) * Insulin-dependent diabetes mellitus * Pregnant or lactating, or wishes to become pregnant within the 24 month duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled) | 24 months | Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties). |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from 3Apr06 to 31Dec07. Subjects were seen at medical clinics/hospitals, usually by their regular doctor and not found through ads. Subjects were asked to enroll if they were having back surgery for back pain. Enrollment was stopped for administrative reasons at 138 subjects; the per protocol plan was at least 350 subjects.
Pre-assignment details
220 subjects were screened and 82 were excluded (59 did not meet criteria and 23 refused participation).Use of non-steroidal anti-inflammatory medications or cyclooxygenase-II (COX-2) inhibitors (a non-steroidal anti-inflammatory drug that directly targets COX-2, an enzyme responsible for inflammation and pain) at time of surgery were exclusionary.
Participants by arm
| Arm | Count |
|---|---|
| HEALOS HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.
The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested. | 92 |
| Control Autograft is bone taken from the subject's own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft. | 46 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 14 | 8 |
| Overall Study | Reason is missing | 1 | 0 |
| Overall Study | Subject did not have 24 month visit | 1 | 0 |
| Overall Study | Subject no show for visit x 3 | 1 | 0 |
| Overall Study | Subject refused to return | 1 | 0 |
| Overall Study | Subject relocated | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | HEALOS | Control | Total |
|---|---|---|---|
| Age Continuous | 47.4 Years | 49.5 Years | 48.45 Years |
| Sex: Female, Male Female | 57 Participants | 27 Participants | 84 Participants |
| Sex: Female, Male Male | 35 Participants | 19 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 77 / 92 | 43 / 46 |
| serious Total, serious adverse events | 23 / 92 | 13 / 46 |
Outcome results
Primary
Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)
Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties).
Time frame: 24 months
Population: Safety Population:All subjects treated. Full Analysis Set(FAS):Subset of Safety Pop. w/follow up. All effectiveness measures were to be assessed on FAS. FAS is intent-to-treat pop. Per Protocol: Subset of FAS who complete study, treated as randomized w/no major protocol deviations. All analyses were to be on this subset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HEALOS | Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled) | 0 Subjects |
| Control | Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled) | 0 Subjects |