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Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device

Primary Purpose

Low Back Pain, Spondylolisthesis, Spinal Stenosis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Lumbar Interbody Fusion
Sponsored by
Medtronic Spinal and Biologics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Spine, Lumbar spine, Spinal fusion, Low back pain, Fusion cage, Posterior lumbar interbody fusion, Bioresorbable, Peek

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • BG Unfallklinik Halle, Klinik für Neurochirurgie
  • Universität Rostock, Neurochirurgie
  • VU University Medical Center
  • Leids Universitair Medisch Centrum

Outcomes

Primary Outcome Measures

Acquired fusion
Clinical outcome

Secondary Outcome Measures

Safety and complications

Full Information

First Posted
October 29, 2004
Last Updated
February 9, 2018
Sponsor
Medtronic Spinal and Biologics
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1. Study Identification

Unique Protocol Identification Number
NCT00095095
Brief Title
Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device
Official Title
Lumbar Interbody Fusion Using The Telamon® Peek™ Versus The Telamon® Hydrosorb™ Fusion Device - A Prospective, Randomized Controlled Trial To Assess Surgical And Clinical Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Terminated
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Spinal and Biologics

4. Oversight

5. Study Description

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 two fusion devices, which are used in spinal surgery in order to promote the fusion of two lumbar vertebrae.
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 removal of an intervertebral disc, and subsequently the union of the two adjacent intervertebral bodies, such that a bony connection is formed within time after surgery. Lumbar spinal fusion is being performed with increasing frequency. Many interbody fusion methods have been described. In recent years, several types of fusion cages have been developed. These cages are made of various materials: titanium, stainless steel, carbon fiber or polyethylethylketone (Peek). Fusion cages have been quickly integrated into orthopedic practice. To date, no studies have been conducted that compare the efficacy of nonresorbable and bioresorbable fusion cage devices. In this study the surgical and clinical outcomes are compared of patients with degenerative lumbar spine disorders who undergo lumbar fusion with a nonresorbable versus a bioresorbable fusion cage. Patients with lumbar spinal disorders will be recruited from several European centers and randomly allocated to one of the two intervention groups. In both treatment groups lumbar spinal fusion is performed using a standardized technique. Patients will be evaluated during two years post-operatively. During this follow up period, the clinical outcome and fusion parameters will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Spondylolisthesis, Spinal Stenosis, Intervertebral Disc Displacement
Keywords
Spine, Lumbar spine, Spinal fusion, Low back pain, Fusion cage, Posterior lumbar interbody fusion, Bioresorbable, Peek

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
102 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Lumbar Interbody Fusion
Primary Outcome Measure Information:
Title
Acquired fusion
Title
Clinical outcome
Secondary Outcome Measure Information:
Title
Safety and complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P.I.J.M. Wuisman, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
BG Unfallklinik Halle, Klinik für Neurochirurgie
City
Halle
ZIP/Postal Code
06112 Halle
Country
Germany
Facility Name
Universität Rostock, Neurochirurgie
City
Rostock
ZIP/Postal Code
18057 Rostock
Country
Germany
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
NL-1081HV
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
NL- 2333 ZA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
14589204
Citation
Vaccaro AR, Singh K, Haid R, Kitchel S, Wuisman P, Taylor W, Branch C, Garfin S. The use of bioabsorbable implants in the spine. Spine J. 2003 May-Jun;3(3):227-37. doi: 10.1016/s1529-9430(02)00412-6.
Results Reference
background
PubMed Identifier
15503461
Citation
Tunc DC, van Dijk M, Smit T, Higham P, Burger E, Wuisman P. Three-year follow-up of bioabsorbable PLLA cages for lumbar interbody fusion: in vitro and in vivo degradation. Adv Exp Med Biol. 2004;553:243-55. doi: 10.1007/978-0-306-48584-8_19. No abstract available.
Results Reference
background
PubMed Identifier
12923466
Citation
Smit TH, Muller R, van Dijk M, Wuisman PI. Changes in bone architecture during spinal fusion: three years follow-up and the role of cage stiffness. Spine (Phila Pa 1976). 2003 Aug 15;28(16):1802-8; discussion 1809. doi: 10.1097/01.BRS.0000083285.09184.7A.
Results Reference
background
PubMed Identifier
12592545
Citation
van Dijk M, Smit TH, Arnoe MF, Burger EH, Wuisman PI. The use of poly-L-lactic acid in lumbar interbody cages: design and biomechanical evaluation in vitro. Eur Spine J. 2003 Feb;12(1):34-40. doi: 10.1007/s00586-002-0458-y. Epub 2002 Sep 6.
Results Reference
background
PubMed Identifier
12461397
Citation
van Dijk M, Smit TH, Burger EH, Wuisman PI. Bioabsorbable poly-L-lactic acid cages for lumbar interbody fusion: three-year follow-up radiographic, histologic, and histomorphometric analysis in goats. Spine (Phila Pa 1976). 2002 Dec 1;27(23):2706-14. doi: 10.1097/00007632-200212010-00010.
Results Reference
background
PubMed Identifier
12449197
Citation
Wuisman PI, van Dijk M, Smit TH. Resorbable cages for spinal fusion: an experimental goat model. J Neurosurg. 2002 Nov;97(4 Suppl):433-9. doi: 10.3171/spi.2002.97.4.0433.
Results Reference
background
PubMed Identifier
12418020
Citation
van Dijk M, Tunc DC, Smit TH, Higham P, Burger EH, Wuisman PI. In vitro and in vivo degradation of bioabsorbable PLLA spinal fusion cages. J Biomed Mater Res. 2002;63(6):752-9. doi: 10.1002/jbm.10466.
Results Reference
background
PubMed Identifier
12401024
Citation
Wuisman PI, van Dijk M, Smit TH. Resorbable cages for spinal fusion: an experimental goat model. Orthopedics. 2002 Oct;25(10 Suppl):s1141-8. doi: 10.3928/0147-7447-20021002-04.
Results Reference
background
PubMed Identifier
11923659
Citation
van Dijk M, Smit TH, Sugihara S, Burger EH, Wuisman PI. The effect of cage stiffness on the rate of lumbar interbody fusion: an in vivo model using poly(l-lactic Acid) and titanium cages. Spine (Phila Pa 1976). 2002 Apr 1;27(7):682-8. doi: 10.1097/00007632-200204010-00003.
Results Reference
background
PubMed Identifier
12449196
Citation
Toth JM, Estes BT, Wang M, Seim HB 3rd, Scifert JL, Turner AS, Cornwall GB. Evaluation of 70/30 poly (L-lactide-co-D,L-lactide) for use as a resorbable interbody fusion cage. J Neurosurg. 2002 Nov;97(4 Suppl):423-32. doi: 10.3171/spi.2002.97.4.0423.
Results Reference
background
PubMed Identifier
12401023
Citation
Toth JM, Wang M, Scifert JL, Cornwall GB, Estes BT, Seim HB 3rd, Turner AS. Evaluation of 70/30 D,L-PLa for use as a resorbable interbody fusion cage. Orthopedics. 2002 Oct;25(10 Suppl):s1131-40. doi: 10.3928/0147-7447-20021002-03.
Results Reference
background
PubMed Identifier
15198495
Citation
Vaccaro AR, Robbins MM, Madigan L, Albert TJ, Smith W, Hilibrand AS. Early findings in a pilot study of anterior cervical fusion in which bioabsorbable interbody spacers were used in the treatment of cervical degenerative disease. Neurosurg Focus. 2004 Mar 15;16(3):E7. doi: 10.3171/foc.2004.16.3.8.
Results Reference
background
PubMed Identifier
15198492
Citation
Lippman CR, Hajjar M, Abshire B, Martin G, Engelman RW, Cahill DW. Cervical spine fusion with bioabsorbable cages. Neurosurg Focus. 2004 Mar 15;16(3):E4. doi: 10.3171/foc.2004.16.3.5.
Results Reference
background
PubMed Identifier
15198491
Citation
Krijnen MR, Smit TH, Strijkers GJ, Nicolay K, Pouwels PJ, Wuisman PI. The use of high-resolution magnetic resonance imaging for monitoring interbody fusion and bioabsorbable cages: an ex vivo pilot study. Neurosurg Focus. 2004 Mar 15;16(3):E3. doi: 10.3171/foc.2004.16.3.4.
Results Reference
background
PubMed Identifier
15198489
Citation
Robbins MM, Vaccaro AR, Madigan L. The use of bioabsorbable implants in spine surgery. Neurosurg Focus. 2004 Mar 15;16(3):E1. doi: 10.3171/foc.2004.16.3.2.
Results Reference
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Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device

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