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

This study has been terminated.
Sponsor:
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT00095095
First received: October 29, 2004
Last updated: October 22, 2012
Last verified: March 2005
  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 Intervention Phase
Low Back Pain
Spondylolisthesis
Spinal Stenosis
Intervertebral Disc Displacement
Device: Lumbar Interbody Fusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medtronic:

Primary Outcome Measures:
  • Acquired fusion
  • Clinical outcome

Secondary Outcome Measures:
  • Safety and complications

Estimated Enrollment: 102
Study Start Date: October 2004
Estimated Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095095

Locations
Germany
BG Unfallklinik Halle, Klinik für Neurochirurgie
Halle, Germany, 06112 Halle
Universität Rostock, Neurochirurgie
Rostock, Germany, 18057 Rostock
Netherlands
VU University Medical Center
Amsterdam, Netherlands, NL-1081HV
Leids Universitair Medisch Centrum
Leiden, Netherlands, NL- 2333 ZA
Sponsors and Collaborators
Medtronic
Investigators
Principal Investigator: P.I.J.M. Wuisman, MD, PhD VU University Medical Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00095095     History of Changes
Other Study ID Numbers: NL04-90
Study First Received: October 29, 2004
Last Updated: October 22, 2012
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Medtronic:
Spine
Lumbar spine
Spinal fusion
Low back pain
Fusion cage
Posterior lumbar interbody fusion
Bioresorbable
Peek

Additional relevant MeSH terms:
Back Pain
Intervertebral Disk Displacement
Low Back Pain
Spinal Stenosis
Spondylolisthesis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on July 22, 2014