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

NCT00095095 | Terminated Phase 4

• 1 other identifier: NL04-90
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Acquired fusion

• Clinical outcome

Secondary Outcomes (1)

• Safety and complications

Interventions

Lumbar Interbody Fusion DEVICE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (4)

BG Unfallklinik Halle, Klinik für Neurochirurgie

Halle, 06112 Halle, Germany

Location

Universität Rostock, Neurochirurgie

Rostock, 18057 Rostock, Germany

Location

VU University Medical Center

Amsterdam, NL-1081HV, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, NL- 2333 ZA, Netherlands

Location

Related Publications (15)

• 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.

  PMID: 14589204 BACKGROUND

• 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.

  PMID: 15503461 BACKGROUND

• 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.

  PMID: 12923466 BACKGROUND

• 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.

  PMID: 12592545 BACKGROUND

• 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.

  PMID: 12461397 BACKGROUND

• 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.

  PMID: 12449197 BACKGROUND

• 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.

  PMID: 12418020 BACKGROUND

• 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.

  PMID: 12401024 BACKGROUND

• 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.

  PMID: 11923659 BACKGROUND

• 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.

  PMID: 12449196 BACKGROUND

• 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.

  PMID: 12401023 BACKGROUND

• 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.

  PMID: 15198495 BACKGROUND

• 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.

  PMID: 15198492 BACKGROUND

• 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.

  PMID: 15198491 BACKGROUND

• 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.

  PMID: 15198489 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Spondylolisthesis; Spinal Stenosis; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Study Officials

• P.I.J.M. Wuisman, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2004
• First Posted: November 1, 2004
• Study Start: October 1, 2004
• Study Completion: May 1, 2006
• Last Updated: February 13, 2018

Record last verified: 2005-03

Locations

DE (2); NL (2)