N/A
Completed N=20
TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
Source: ClinicalTrials.gov NCT01198470 ↗Enrolled (actual)
20
Serious AEs
30.0%
Results posted
Oct 2018
Primary outcomePrimary: 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
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
16 | — |
| PRIMARY Number of Participants With No Device Failures |
17 | — |
| PRIMARY Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage |
— | — |
| PRIMARY Number of Participants Determined to Have a Normal Neurological Status |
15 | — |
Eligibility Criteria
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 exclusion criteria as specified in approved IDE protocol
Data sourced from ClinicalTrials.gov (NCT01198470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.