Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00878579
Other study ID # PDS-002-DDD
Secondary ID
Status Terminated
Phase Phase 2
First received April 7, 2009
Last updated February 19, 2013
Start date March 2009
Est. completion date February 2013

Study information

Verified date February 2013
Source Interventional Spine, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels from L3-S1 to relieve back pain associated with degenerative disc disease.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Confirmation of DDD (back pain with degeneration of the disc by patient history, physical exam, and radiographic studies and with one or more of the following factors:

- Osteophyte formation of facet joints or vertebral endplates

- Facet joint degeneration (no more than mild to moderate)

- Subjects with =50% collapse of disc as compared to the adjacent level

- Subjects with or without a contained herniated nucleus pulposus <5 mm and no free fragment

2. Skeletally mature subjects aged between 18 and 70 years of age inclusive.

3. Subjects with primarily back pain associated with degenerative disc disease of the lumbar spine at one level or two adjacent levels from L3 through S1. Subjects may have a lesser degree of leg pain at the same level(s).

4. Subjects who require surgical or minimally invasive intervention, who have failed to adequately improve following 6 months of non-operative therapy.

5. Subject is a surgical candidate for a posterior approach to the lumbar spine and is suitable for fusion using pedicle screw systems

6. Subjects with a minimum baseline Oswestry Score of 40% (20/50).

7. Subjects with a minimum baseline VAS Score of 40/100 mm.

8. MRI diagnostic for DDD within 3 months of the screening visit.

9. Subjects who are mentally, physically and psychosocially able to cooperate with the study procedures and return for all required follow-up visits.

10. Subjects who are able to understand this study and have given voluntary, written informed consent to participate in this study.

Exclusion Criteria:

1. Subjects who have leg pain greater than back pain.

2. Subjects with severe facet degeneration, radiographic findings of severe facet joint disease, degeneration or misshapen facet(s) or structural anomalies at the target level(s) that would preclude placement of the PDS device or pedicle screw systems.

3. Subjects who require a pedicle screw smaller than 4.5 mm.

4. Subjects with Modic 3 bone changes at the target level(s).

5. Spondylolisthesis > Grade 1 and/or spondylolysis at the target level(s).

6. Subjects with myelopathy or cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (retention or incontinence).

7. Subjects with fixed motor deficit and/or peripheral neuropathy.

8. Subjects with prior discectomy at the target level(s).

9. Subjects with prior spine surgery, trauma, metastatic disease, or spinal deformity due to scoliosis (Cobb angle > 15 degrees) or kyphosis (> 11 degrees) at any lumbar level.

10. Subjects who have used any investigational drug or device within the past 30 days or have had an experimental spinal implant at any time.

11. Subjects with active local or systemic infection.

12. Subjects with osteoporosis. A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen subjects. If DEXA is required, exclusion will be defined as a DEXA bone density measured T scored < -1.0.

13. Subjects with metabolic bone disease (e.g. osteomalacia, Paget's disease).

14. Subjects with rheumatoid arthritis or other autoimmune spondyloarthropathies.

15. Subjects with a systemic disease that compromises life expectancy (e.g. HIV, AIDS, hepatitis) or are on immuno-suppressive agents.

16. Subjects who are taking any drug known to potentially interfere with bony/soft tissue healing, (e.g., steroids at any dose daily within the last 12 months).

17. Subjects with active malignancy: A subject with a history of any invasive malignancy (except non-melanoma skin cancer), unless s/he has been treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years.

18. Subjects with a known allergy to titanium and/or polycarbonate urethane (PCU).

19. Subjects who have existing conditions or pending litigation claims that could compromise their participation, follow-up care, or treatment outcomes (e.g., drug or alcohol abuse).

20. Subjects with a BMI of = 40 kg/m2 or weight > 275 pounds (125 kg).

21. Subjects who are pregnant or are planning a pregnancy during the study period.

22. Subjects who are prisoners.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
PDS System
Percutaneous Dynamic Stabilization System
Fusion
Transforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Interventional Spine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in Oswestry Disability Index (ODI) 2 Years No
See also
  Status Clinical Trial Phase
Completed NCT01198470 - TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study N/A
Terminated NCT00744861 - Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery N/A
Completed NCT00949936 - Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking N/A
Completed NCT03974711 - Rampart Duo Clinical (RaDical) Post-Market Study
Recruiting NCT01721889 - Radiostereometric Analysis of Spine Arthrodesis N/A
Terminated NCT02139527 - CARES Lumbar Artificial Disc Registry Phase 4
Completed NCT01640977 - A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF N/A
Terminated NCT01689922 - The Effectiveness of Anti-Gravity Treadmill Training N/A
Enrolling by invitation NCT02529566 - Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine N/A
Completed NCT02347410 - Spineology Clinical Outcomes Trial: An IDE Investigation N/A
Terminated NCT02070484 - Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease N/A
Terminated NCT01294007 - Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF) N/A
Terminated NCT01293981 - Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF) N/A
Terminated NCT00640029 - Evaluation of the Prosthetic Disc Replacement N/A
Terminated NCT00456378 - Study of the Safety and Effectiveness of DIAMâ„¢ Spinal Stabilization System Versus Conservative Care N/A
Completed NCT03647501 - Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages N/A
Active, not recruiting NCT02297256 - Prospective Study of Thoracolumbar Spinal Fusion Graft N/A
Recruiting NCT05516992 - Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine Phase 3
Completed NCT01323387 - Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer N/A