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

February 9, 2018 updated by: Medtronic Spinal and Biologics

Lumbar Interbody Fusion Using The Telamon® Peek™ Versus The Telamon® Hydrosorb™ Fusion Device - A Prospective, Randomized Controlled Trial To Assess Surgical And Clinical Outcomes

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Halle, Germany, 06112 Halle
        • BG Unfallklinik Halle, Klinik für Neurochirurgie
      • Rostock, Germany, 18057 Rostock
        • Universität Rostock, Neurochirurgie
  • Netherlands
      • Amsterdam, Netherlands, NL-1081HV
        • VU University Medical Center
      • Leiden, Netherlands, NL- 2333 ZA
        • Leids Universitair Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical outcome
Acquired fusion

Secondary Outcome Measures

Outcome Measure
Safety and complications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Spinal and Biologics

Investigators

  • Principal Investigator: P.I.J.M. Wuisman, MD, PhD, Amsterdam UMC, location VUmc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

October 29, 2004

First Submitted That Met QC Criteria

October 29, 2004

First Posted (ESTIMATE)

November 1, 2004

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

March 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL04-90

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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