Trial document




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  DRKS00003591

Trial Description

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Title

Anterior cervical discectomy and fusion in cervical degenerative disc disease: comparison between intervertebral bone cement and PEEK-cages

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Cervical degenerative disc disease (herniated discs and spinal stenoses) can lead to radicular and/or myelopathic symptoms. Neurological deficits or conservatively not controllable symptoms often require surgery. The operation aims to decompress neural structures and to stabilize the cervical spine. Depending on the location and extent of the pathology, anterior or posterior surgery has to be considered. In cervical disc degeneration in 1 or 2 cervical segments, mostly the anterior approach with removal of the intervertebral disc (discectomy), decompression of neural structures (spinal cord and nerve roots) and implantation of a disc replacement will be performed.
Previously no disc replacement or an autologous bone graft was used. In the absence of disc replacement, however, loss of height of the operated segment with kyphotic deformity was observed, leading to narrowing of the neural foramina. In the case of the iliac crest graft, considerable local pain and complications occurred at the sampling point. As part of further development bone cement was implanted into the intervertebral disc space in order to obtain the segmental height and to avoid the problems at ​​the sampling point of the bone graft. Currently, spine surgeons increasingly use intervertebral cages, which initially consisted of titanium. Now, mostly cages made of polyetheretherketone (PEEK) were used. Both methods are valid techniques and had often been reported in the literature. A comparative study between bone cement and PEEK cages as cervical disc replacement has not been reported in the literature so far.
The aim of this study is the retrospective, comparative analysis of bone cement and PEEK cages as intervertebral disc replacement for cervical discectomy in degenerative disc disease. Clinical, radiological and subjective characteristics should be evaluated.

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Brief Summary in Scientific Language

Cervical degenerative disc disease (herniated discs and spinal stenoses) can lead to radicular and/or myelopathic symptoms. Neurological deficits or conservatively not controllable symptoms often require surgery. The operation aims to decompress neural structures and to stabilize the cervical spine. Depending on the location and extent of the pathology, anterior or posterior surgery has to be considered. In cervical disc degeneration in 1 or 2 cervical segments, mostly a ventral discectomy with decompression of neural structures and implantation of a disc replacement will be performed.
Previously no disc replacement or an autologous bone graft was used. In the absence of disc replacement, however, loss of height of the operated segment with kyphotic deformity was observed, leading to narrowing of the neural foramina. In the case of the iliac crest graft, considerable local pain and complications occurred at the sampling point. As part of further development bone cement was implanted into the intervertebral disc space in order to obtain the segmental height and to avoid the problems at ​​the sampling point of the bone graft. Currently, spine surgeons increasingly use intervertebral cages, which initially consisted of titanium. Now, mostly cages made of polyetheretherketone (PEEK) were used. Both methods are valid techniques and had often been reported in the literature. A comparative study between bone cement and PEEK cages as cervical disc replacement has not been reported in the literature so far.
The aim of this study is the retrospective, comparative analysis of bone cement and PEEK cages as intervertebral disc replacement for cervical discectomy in degenerative disc disease. Clinical, radiological and subjective characteristics should be evaluated.

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Organizational Data

  •   DRKS00003591
  •   2012/03/06
  •   [---]*
  •   yes
  •   Approved
  •   70/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   M50.2 -  Other cervical disc displacement
  •   M48.02 -  [generalization M48.0: Spinal stenosis]
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Interventions/Observational Groups

  •   Cervical ventral discectomy with implantation of PEEK cages
  •   Cervical ventral discectomy with implantation of Sulcem® PMMA dowels
  •   Cervical ventral discectomy with implantation of Palacos® PMMA dowels
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Retrospective, at least one year postoperatively. Acquisition of the subjective condition via questionnaires (NRS, NDI, SF-36) and of radiological characteristics via X rays and CT scan (fusion, cervical alignment).

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Secondary Outcome

Reoperation in the operated or adjacent level.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/03/07
  •   110
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Adult patients with cervical degenerative disc disease from C2 to C7; cervical radiculopathy myelopathy before surgery; anterior cervical surgery in 1 or 2 segments with implantation of bone cement or PEEK cage as intervertebral disc replacement.

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Exclusion Criteria

Prior surgery on the cervical spine; cervical surgery in more than two segments; posterior surgery.

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Addresses

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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/06/04
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Trial Publications, Results and other Documents

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