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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00095095
• Other study ID #: NL04-90
• Status: Terminated
• Phase: Phase 4
• First received: October 29, 2004
• Last updated: February 9, 2018
• Start date: October 2004
• Est. completion date: May 2006

Study information

• Verified date: March 2005
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Lumbar Interbody Fusion

Locations

Country	Name	City	State
Germany	BG Unfallklinik Halle, Klinik für Neurochirurgie	Halle
Germany	Universität Rostock, Neurochirurgie	Rostock
Netherlands	VU University Medical Center	Amsterdam
Netherlands	Leids Universitair Medisch Centrum	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Countries where clinical trial is conducted

Germany,  Netherlands, 

References & Publications (15)

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. — View 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. — View Citation

Robbins MM, Vaccaro AR, Madigan L. The use of bioabsorbable implants in spine surgery. Neurosurg Focus. 2004 Mar 15;16(3):E1. Review. — View Citation

Smit TH, Müller 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Epub 2002 Sep 6. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquired fusion
Primary	Clinical outcome
Secondary	Safety and complications