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Low Back PainPhase 4NCT00095095

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

A Phase 4 study testing Lumbar Interbody Fusion in people with Low Back Pain and Spondylolisthesis, run by Medtronic Spinal and Biologics at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Low Back Pain, Spondylolisthesis, Spinal Stenosis
What is being tested?
Lumbar Interbody Fusion
Type of treatment
Medical device
How many people
102 participants
Where
4 sitesin 2 countries
Study dates
Oct 2004to May 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Additional posterior fixation is mandatory
  • Use of autograft of the iliac crest is possible
  • Ability to provide informed consent

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Germany2 sites

  • BG Unfallklinik Halle, Klinik für Neurochirurgie

    Halle, 06112 Halle

  • Universität Rostock, Neurochirurgie

    Rostock, 18057 Rostock

Other trials in Germany

Netherlands2 sites

  • VU University Medical Center

    Amsterdam, NL-1081HV

  • Leids Universitair Medisch Centrum

    Leiden, NL- 2333 ZA

Other trials in Netherlands

About this 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

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.

Read the 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.

Being tested
Lumbar Interbody Fusion
Keywords
Spine, Lumbar spine, Spinal fusion, Low back pain, Fusion cage, Posterior lumbar interbody fusion, Bioresorbable, Peek
Medical subject headings
Low Back Pain, Spondylolisthesis, Spinal Stenosis, Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lumbar Interbody FusionDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acquired fusion

  2. Clinical outcome

Secondary outcomes (1)

  1. Safety and complications

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2004 (estimated)
  2. Study startOct 2004
  3. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
102 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00095095
Sponsor's protocol ID
NL04-90
Status last verified
Mar 2005
First submitted
29 Oct 2004
Last updated
13 Feb 2018
Results posted
No

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. doi: 10.1016/s1529-9430(02)00412-6.

    PubMed 14589204

  • 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.

    PubMed 15503461

  • 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.

    PubMed 12923466

  • 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.

    PubMed 12592545

  • 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.

    PubMed 12461397

  • 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.

    PubMed 12449197

  • 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.

    PubMed 12418020

  • 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.

    PubMed 12401024

  • 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.

    PubMed 11923659

  • 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.

    PubMed 12449196

  • 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.

    PubMed 12401023

  • 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.

    PubMed 15198495

  • 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.

    PubMed 15198492

  • 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.

    PubMed 15198491

  • 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.

    PubMed 15198489

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lumbar Interbody Fusion in people with Low Back Pain and Spondylolisthesis, run by Medtronic Spinal and Biologics at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acquired fusion. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00095095, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.

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