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Clinical Trial: Lumbar Interbody Fusion using the Telamon® Peek™ versus the Telamon® Hydrosorb™ Fusion Device
This study is currently recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Low Back Pain Spondylolisthesis Spinal Stenosis Intervertebral Disc Displacement | Device: Lumbar Interbody Fusion | Phase IV |
MedlinePlus related topics: Back Pain; Herniated Disk; Spinal Diseases; Spinal Stenosis; Tailbone Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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
Secondary Outcomes: Safety and complications
Expected Total Enrollment: 210
Study start: October 2004; Expected completion: October 2009
Last follow-up: December 2008; Data entry closure: January 2009
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.
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Both
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
Location and Contact Information
M. Verweij +31 204442355 orthop@vumc.nl
Denmark
Aarhus Kommunehospital, Aarhus, 8000 Aarhus C, Denmark; Not yet recruiting
F.B. Christensen, MD, PhD +45 8949 3333 fbc@daolnet.dk
C. Bünger, MD, PhD, Principal Investigator
F.B. Christensen, MD, PhD, Sub-Investigator
Hospital Aalburg, Aalburg, 9100 Aalborg, Denmark; Not yet recruiting
S Eiskjaer, MD, PhD, Principal Investigator
Germany
BG Unfallklinik Halle, Klinik für Neurochirurgie, Halle, 06112 Halle, Germany; Recruiting
H.J. Meisel, MD, PhD, Principal Investigator
Universität Rostock, Neurochirurgie, Rostock, 18057 Rostock, Germany; Recruiting
+49 381 494 6436
S. Sola, MD, PhD, Principal Investigator
Netherlands
VU University Medical Center, Amsterdam, NL-1081HV, Netherlands; Recruiting
M.G. Mullender, PhD +31(0)204448687 m.mullender@vumc.nl
P.I.J.M. Wuisman, MD, PhD, Principal Investigator
B.J. van Royen, MD, PhD, Sub-Investigator
Academisch Ziekenhuis Maastricht, Maastricht, NL- 6229 HX, Netherlands; Not yet recruiting
A van Ooij, MD, PhD, Principal Investigator
L van Rhijn, MD, PhD, Sub-Investigator
Ignatius Ziekenhuis, Breda, NL - 4818 CK, Netherlands; Not yet recruiting
orthobeurden@hetnet.nl
A.F.A. van Beurden, MD, PhD, Principal Investigator
Canisius Wilhelmina Ziekenhuis, Nijmegen, NL - 6532 SZ, Netherlands; Not yet recruiting
R. Donk, MD, PhD, Principal Investigator
R.H.M.A. Bartels, MD, PhD, Sub-Investigator
Leids Universitair Medisch Centrum, Leiden, NL- 2333 ZA, Netherlands; Recruiting
P.D.S. Dijkstra, MD, PhD, Principal Investigator
Medisch Centrum Alkmaar, Alkmaar, NL - 1815 JD, Netherlands; Not yet recruiting
A.J. de Gruijter, MD, PhD, Principal Investigator
Medisch Centrum Den Haag, Den Haag, 2501CK, Netherlands; Not yet recruiting
W C Peul, MD, Principal Investigator
South Africa
Milpark Hospital, Gauteng, South Africa; Not yet recruiting
F Snyckers, MD, PhD, Principal Investigator
Spain
Hospital Universitaro, Valencia, 46017 Valencia, Spain; Not yet recruiting
A. Martin, MD, PhD, Principal Investigator
Switzerland
Klinik St. Anna, Luzern, 6006 Luzern, Switzerland; Not yet recruiting
F. Sgier, MD, PhD, Principal Investigator
Klinik Willhelm Schulthess, Zurich, 8008 Zürich, Switzerland; Not yet recruiting
F. Porchet, MD, PhD, Principal Investigator
P.I.J.M. Wuisman, MD, PhD, Principal Investigator, VU University Medical Center
More Information
Publications
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. Review.
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. No abstract available.
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. 2003 Aug 15;28(16):1802-8; discussion 1809.
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. Epub 2002 Sep 06.
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. 2002 Dec 1;27(23):2706-14.
Wuisman PI, van Dijk M, Smit TH. Resorbable cages for spinal fusion: an experimental goat model. J Neurosurg Spine. 2002 Nov;97(4):433-9.
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.
Wuisman PI, van Dijk M, Smit TH. Resorbable cages for spinal fusion: an experimental goat model. Orthopedics. 2002 Oct;25(10 Suppl):s1141-8.
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. 2002 Apr 1;27(7):682-8.
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 Spine. 2002 Nov;97(4):423-32.
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.
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.
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.
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.
Robbins MM, Vaccaro AR, Madigan L. The use of bioabsorbable implants in spine surgery. Neurosurg Focus. 2004 Mar 15;16(3):E1. Review.
Record last reviewed: March 2005
Last Updated: March 29, 2005
Record first received: October 29, 2004
ClinicalTrials.gov Identifier: NCT00095095
Health Authority: Netherlands: Independent Ethics Committee (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Lumbar Puncture Under Fluoroscopy (Cleveland Clinic)
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