Lumbar Degenerative Disc Disease
Conditions
Keywords
Low back pain, Leg pain, Discogenic pain, Degenerative Disc Disease (DDD), Herniated disc, Radiculopathy
Brief summary
The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.
Interventions
DEVICETRIUMPH® Lumbar Artificial Disc
The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.
Sponsors
Globus Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Degenerative Disc Disease in one vertebral level between L1 and S1 * Able to understand and sign informed consent * Had at least 6 months of conservative treatment * Oswestry Disability Index Score of at least 30 (one a 100 point scale) * Other inclusion criteria as specified in approved IDE protocol
Exclusion criteria
* Bilateral leg pain * Back or leg pain of unknown etiology * Prior fusion surgery or another spinal device implanted at any other lumbar level * Osteoporosis or osteopenia * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline | 24 months | The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. |
| Number of Participants With No Device Failures | 24 months | Any device requiring surgical revision, reoperation, removal or supplemental fixation will be considered a device failure |
| Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage | 24 months | Major vessel injury is defined as injury of the aorta or vena cava or other major vessels (e.g. iliac arteries, superior rectal artery, iliac veins, and their branches), caused by the surgery or device, resulting in significant blood loss or requiring additional surgery to correct. Neurological damage is defined as damage to the spinal cord or a nerve root caused by the surgery or device, resulting in neurologic deficit that persists for more than 3 months and is without improvement, is progressive, or involves motor loss. Major complications are reported on adverse event case report forms. |
| Number of Participants Determined to Have a Normal Neurological Status | 24 months | Neurological status was assessed using a neurological status scale, which is based on four types of measurement parameters: motor, sensory, reflexes, and straight leg raise. The method for summarizing neurological status is described below. Each parameter (i.e. motor, sensory, reflexes, straight leg raise) is coded as follows: Motor 0 Total Paralysis 1. Palpable or Visible Contraction 2. Active Movement, Gravity Eliminated 3. Active Movement, Against Gravity 4. Active Movement, Against Some Resistance 5. Active Movement, Against Full Resistance Sensory 0 Absent 1. Impaired 2. Normal Reflexes 0 Absent or Trace 1. Hyper-reflexive 2. Normal or hypo-reflexive Straight Leg Raise 0 0° - 70° (Abnormal) 1 \> 70°-90° (Normal) If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TRIUMPH® Artificial Disc Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).
TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | TRIUMPH® Artificial Disc |
|---|---|
| Age, Continuous | 37.9 years STANDARD_DEVIATION 9.8 |
| Height | 67.2 inches STANDARD_DEVIATION 3 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 6 Participants |
| Weight | 178.1 pounds STANDARD_DEVIATION 26.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 17 / 20 |
| serious Total, serious adverse events | 6 / 20 |
Outcome results
Primary
Number of Participants Determined to Have a Normal Neurological Status
Neurological status was assessed using a neurological status scale, which is based on four types of measurement parameters: motor, sensory, reflexes, and straight leg raise. The method for summarizing neurological status is described below. Each parameter (i.e. motor, sensory, reflexes, straight leg raise) is coded as follows: Motor 0 Total Paralysis 1. Palpable or Visible Contraction 2. Active Movement, Gravity Eliminated 3. Active Movement, Against Gravity 4. Active Movement, Against Some Resistance 5. Active Movement, Against Full Resistance Sensory 0 Absent 1. Impaired 2. Normal Reflexes 0 Absent or Trace 1. Hyper-reflexive 2. Normal or hypo-reflexive Straight Leg Raise 0 0° - 70° (Abnormal) 1 \> 70°-90° (Normal) If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TRIUMPH® Artificial Disc | Number of Participants Determined to Have a Normal Neurological Status | 15 Participants |
Primary
Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline
The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TRIUMPH® Artificial Disc | Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline | 16 Participants |
Primary
Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage
Major vessel injury is defined as injury of the aorta or vena cava or other major vessels (e.g. iliac arteries, superior rectal artery, iliac veins, and their branches), caused by the surgery or device, resulting in significant blood loss or requiring additional surgery to correct. Neurological damage is defined as damage to the spinal cord or a nerve root caused by the surgery or device, resulting in neurologic deficit that persists for more than 3 months and is without improvement, is progressive, or involves motor loss. Major complications are reported on adverse event case report forms.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TRIUMPH® Artificial Disc | Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage | 0 Participants |
Primary
Number of Participants With No Device Failures
Any device requiring surgical revision, reoperation, removal or supplemental fixation will be considered a device failure
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TRIUMPH® Artificial Disc | Number of Participants With No Device Failures | 17 Participants |