Status:
TERMINATED
Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Low Back Pain
Spondylolisthesis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Lumbar spinal fusion is commonly performed as a "last resort" in patients with chronic low back pain caused by degenerative changes and instability of the spine. The aim of this study is to compare tw...
Detailed Description
Lumbar spinal fusion is commonly performed as a "last resort" in patients with chronic low back pain caused by degenerative changes and instability of the spine. The surgical treatment involves the re...
Eligibility Criteria
Inclusion
- Both genders, age between 18 and 70 years
- Chronic low back pain (\> 3 months) with or without leg pain but no signs of motor loss
- Based on clinical history, physical examination, and radiographic signs, pain interpreted as emanating from L4-L5 or L5-S1
- Symptoms refractory to conservative treatment for at least 3 months
- Evidence of degenerative changes at L4-L5 or L5-S1 (spondylosis) on plain radiographs and/or CT scan, and/or MRI. The pathology should be predominant on one level.
- Single-level Posterior Lumbar Interbody Fusion surgery (PLIF) is indicated by the spine surgeon
- Additional posterior fixation is mandatory
- Use of autograft of the iliac crest is possible
- Ability to provide informed consent
Exclusion
- Previous lumbar spinal fusion
- All other previous spinal surgery except for successful removal of a herniated disc more than 2 years before entering the study
- Symptomatic degenerative disc disorder at more than one lumbar level
- Pregnancy or intention to become pregnant during the two year study
- Ongoing psychiatric illness
- Evidence of alcohol and/or drug abuse
- Inability to complete the questionnaires
- Inability to walk independently
- Other indications than degenerative spinal disorders including a metabolic bone disease, osteoporosis, infection, old fracture, inflammatory process, or neoplasm
- Obvious painful and disabling arthritic hip joints
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00095095
Start Date
October 1 2004
End Date
May 1 2006
Last Update
February 13 2018
Active Locations (4)
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1
BG Unfallklinik Halle, Klinik für Neurochirurgie
Halle, Germany, 06112 Halle
2
Universität Rostock, Neurochirurgie
Rostock, Germany, 18057 Rostock
3
VU University Medical Center
Amsterdam, Netherlands, NL-1081HV
4
Leids Universitair Medisch Centrum
Leiden, Netherlands, NL- 2333 ZA