Trial document




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  DRKS00009238

Trial Description

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Title

Prospective randomized trial regarding the use of PEEK-Rods for stabilization in lumbar circumferential fusion

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

In the case of failure of conservative treatment circumferential spondylodesis with transpedicular stabilization and intersomatic support with a cage and a bone graft represents the treatment of choice for highly degenerated and unstable lumbar spine segments (possibly with consecutive neurologic deficits). Adjacent segment degeneration and non-fusion (pseudoarthrosis) are two of the main problems following lumbar fusion surgery with incidences of about 25% and 10-15%. Epidemiological studies could demonstrate that the described spinal pathology as well as both complications are mainly present in the advanced age. This leads to a relevant rate of revision surgeries. Because of the increasing number of fusion surgeries and the aging of the population the consequence is a significant burden for the patients as well as the health care system.
According to the results of animal studies, possibly in aged compared to younger individuals a stronger mechanical input on the "callus" is necessary for a successful bridging of a bone defect. The steady aspiration to increase the primary stability of the internal fixation devices for successful fusion counteracts this principle, causes stress-shielding to the bone grafts in the intervertebral space, and therefore, might be one reason for the increased rate of non-unions in aged patients. Additionally, biomechanical studies provide evidence that a semi-rigid fixation can lead to a reduction of the load of adjacent segments. According to this, it seems promising to use less rigid fixation devices to increase the mechanical load on the intervertebral bone grafts by means of an increased load-sharing and concomitant reduced stress-shielding. This goal could potentially be achieved by changing the rod material from titanium to PEEK. So far, no prospective randomized clinical trial exists, researching the influence of the rod material on the success of intersomatic fusion or the progression of adjacent segment degeneration.
Therefore, the aim of the present project is to investigate the influence of the use of a PEEK vs. a titanium rod on (I) the success of intersomatic fusion and (II) the progression of adjacent segment degeneration. Additionally, (III) The impact of age and bone density on the results will be focused.

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Organizational Data

  •   DRKS00009238
  •   2015/08/17
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  •   yes
  •   Approved
  •   4470-6/15, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   M53.26 -  [generalization M53.2: Spinal instabilities]
  •   M42.16 -  [generalization M42.1: Adult osteochondrosis of spine]
  •   M53.27 -  [generalization M53.2: Spinal instabilities]
  •   M42.17 -  [generalization M42.1: Adult osteochondrosis of spine]
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Interventions/Observational Groups

  •   Group PEEK:
    Use of PEEK(Polyetheretherketon)-rods for transpedicular stabilization in single-level transforaminal lumbar interbody fusions (TLIF)
  •   Group TITANIUM:
    Use of titanium-rods for transpedicular stabilization in single-level transforaminal lumbar interbody fusions (TLIF)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

1. Rate of successful fusion; CT and X-Ray (6 months after surgery)

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Secondary Outcome

1. Progression of degeneration of the cranial adjacent 2 segments; X-ray (6 month after surgery) and MRI (24 months after surgery)

2. Clinical Outcome
(Pain: VAS for back-, leg-, and overall pain as well as its frequency - preoperatively, 1 week, 6 weeks, 6, 12, and 24 months postoperatively;
Function: Oswestry Disability Index - preoperatively, 6 weeks, 6, 12, and 24 months postoperatively;
Quality of life: SF-36 - preoperatively, 6 weeks, 6, 12, and 24 months postoperatively)

3. Age dependency of the criteria fusion success and adjacent segment degeneration

4. Bone density dependency of the criteria fusion success and adjacent segment degeneration

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/09/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

Patients with persistent lumbar, lumbosacral and/or non-radicular / radicular complaints, after failed conservative treatment of a period of at least 6 months will be included in the study. At the same time, in MRI a single-level lumbar osteochonditis Modic Type ≥ 1 based on an idiopathic intervertebral disc degeneration Pfirrmann ≥ III and/or a facet joint degeneration Grade 3 or 4 according to Fujiwara has to be present. Additional spinal or neuroforaminal stenoses as well as nucleus prolapses at the index segment do not represent contraindications. Degenerative spondylolistheses of the index segment up to Meyerding I as well as previous sequestrektomies or selective inter laminar decompression surgeries at the index segment do also not lead to exclusion. Every patient has to sign an agreement form with study

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Exclusion Criteria

Patients with symptomatic segment degeneration of more than 1 lumbar segment as well as patients who had undergone spinal surgeries different from the described under inclusion criteria will be excluded from the study.
Further exclusion criteria are spondylolistheses > Meyerding I or lumbar scoliosis Cobb-angle ≥10°. Patients with chronic nikotine-, alcohol- or drug abusus, a known allergy against (parts of) the implants, a „Body-Mass-Index“ (BMI) >30 kg/m2, as well as pregnant patients will be excluded from the study. Additionally, clinical, blood parameters or radiological signs of a renal- and liver disease, malignant tumours, chronic medication with corticoids or bone density increasing antiosteoporotic substances, presence of a chronic pain / somatization disorder (> Stadium I according to Gerbershagen), epilepsy or further diseases or reasons leading to recurrent falls lead to exclusion. Beside this, patients with the need for screw augmentation with bone cement as well as patients with the need of surgical revision due to screw misplacement or lateral screw misplacement > grade 2 (according to Mirza) in postoperative CT weill be excluded because of its negative influence on the grade of stability of the segment fixation.

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Addresses

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    • Klinik für Orthopädie einschl. Unfallchirurgie am Waldkrankenhaus "Rudolf Elle" gGmbH incl. Lehrstuhl für Orthopädie der Friedrich-Schiller-Universität Jena
    • Mr.  Univ.-Prof. Dr. med.  Georg  Matziolis 
    • Klosterlausnitzer Str. 81
    • 07607  Eisenberg
    • Germany
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    • Klinik für Orthopädie einschl. Unfallchirurgie am Waldkrankenhaus "Rudolf Elle" gGmbH incl. Lehrstuhl für Orthopädie der Friedrich-Schiller-Universität Jena
    • Mr.  Priv.-Doz. Dr. med.  Patrick  Strube 
    • Klosterlausnitzer Str. 81
    • 07607  Eisenberg
    • Germany
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    • Klinik für Orthopädie einschl. Unfallchirurgie am Waldkrankenhaus "Rudolf Elle" gGmbH incl. Lehrstuhl für Orthopädie der Friedrich-Schiller-Universität Jena
    • Mr.  Dr. med.  Timo  Zippelius 
    • Klosterlausnitzer Str. 81
    • 07607  Eisenberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Klinik für Orthopädie einschl. Unfallchirurgie am Waldkrankenhaus "Rudolf Elle" gGmbH incl. Lehrstuhl für Orthopädie der Friedrich-Schiller-Universität Jena
    • Klosterlausnitzer Str. 81
    • 07607  Eisenberg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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