Trial document




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  DRKS00012976

Trial Description

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Title

3D navigated kyphoplasty versus standard 2D fluoroscopy guided kyphoplasty - a prospective randomised trial to compare accuracy of the trajectory, complications, radiation dose and outcome

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Trial Acronym

kyphona

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Vertebral body cement augmentation is a common treatment strategy for osteoporotic and tumor related spinal fractures. During this minimally invasive procedure an injection needle (trocar) is introduced into the vertebral body using 2D fluoroscopy. High precision is necessary to avoid lesions of adjacent structures such as blood vessels, neural structures and organs. This might possibly lead to cerebrospinal fluid leakage, paralysis and organ injury such as the lungs. Additionally, cement can possibly intrude into the spinal canal and adjacent vessels as well as the lung and the heart. In worst case this might result in cardiac arrest. In this study, we hypothesize that accuracy of needle positioning as well as the risk of complications can significantly be improved by using 3D navigation compared to 2D fluoroscopy. All adult patients presenting with osteoporotic or tumor related spinal fractures will be asked to participate. Exclusion criteria are: no informed consent, pregnancy, planned opened surgery, stabilization of the involved segments. Patients will randomly be assigned to one of the two groups containing 34 patients each. One group will be operated on using the standard 2D fluoroscopy technique and the other using 3D navigation. Accuracy of the needle position as well as surgery results after 3 and 12 months will be evaluated, possible complications will be assessed and compared between both groups.

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Brief Summary in Scientific Language

Kyphoplasty is a common treatment for osteoporotic and/or metastatic spinal fractures. In a standard procedure, the vertebral body will be cemented by introducing a trocar needle through the pedicles inside the vertebral body relying on 2D fluoroscopy. Despite the advantage of a minimally invasive therapy, leading to fast pain relief and quick recovery, there are some possible complications. On one hand cement leakage into the spinal canal or segmental vessels might lead to possible pulmonary or cardiac embolism. On the other hand, we are facing the difficulties in relation to the deteriorated anatomy of the pedicles and therefore difficult radio morphologic orientation using 2D fluoroscopy. Trajectory malpositioning might lead to complications such as cerebrospinal fluid leakage or fistula, neurological deterioration including radiculopathy, neuropathy or paraplegia, or injury of an organ such as the lungs.
The primary goal of our prospective randomized study is to determine whether using 3D navigation for Kyphoplasty can significantly increase the accuracy of the trajectory in comparison to the conventional 2D fluoroscopy. Secondly, we want to evaluate if the risk of complications in relation to the trajectory as well as the cement are significantly reduced by the help of 3D navigation.
The accuracy of needle placement/trajectory will be assessed by the modified Gertzbein &Robbins Classification: Grade 1,2 = high accuracy and Grade 3,4,5 = low accuracy and compared by a two-sided z-test. The level of significance is set to 0.05. Additionally, we will evaluate whether rate of complications, surgery time, radiation dose and outcome (VAS; ODI, and Quality of life after 3 and 12 months) can significantly be improved by the use of 3D navigation.
All adult patients presenting with osteoporotic or pathological vertebral fractures at the level of the dorsal and lumbar spine will be included. Exclusion criteria are: no informed consent, pregnancy, planned open surgery, stabilization involving the same segment. Assuming 27% of low accuracy in the conventional 2D fluoroscopy group and 3% of low accuracy using 3D navigation (Sembrano et al 2015) a number of 34 patients per group is needed to reach a level of 0.05 significance with a power of 80%. 34 will be randomly assigned to one of the trial groups, the conventional 2D fluoroscopy group or the 3D navigation group.

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Organizational Data

  •   DRKS00012976
  •   2017/09/20
  •   [---]*
  •   yes
  •   Approved
  •   311/17S, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   M80.88 -  [generalization M80.8: Other osteoporosis with pathological fracture]
  •   C79.5 -  Secondary malignant neoplasm of bone and bone marrow
  •   T08.1 -  [generalization T08: Fracture of spine, level unspecified]
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Interventions/Observational Groups

  •   Standard 2D fluoroscopy guided kyphoplasty
  •   3D navigated kyphoplasty
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

We want to evaluate if the accuracy of the vertebroplasty-needle position is significantly better using 3D navigation in comparison to standard 2D fluoroscopy. To evaluate accuracy the modified Gertzbein and Robbins classification is used (grade 1, 2 high accuracy and grade 3,4,5 low accuracy).

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Secondary Outcome

We hypothesise that the rate of complications in relation to needle positioning is significantly lower in the navigated kyphoplasty group. Additionally we will evaluate if there is a significant difference in total radiation dose and surgery time, as well es postoperative outcome measured by VAS (Visuell Pain Scale); ODI (Oswestry Disability Index) and quality of life (SF-12,Eq5) before and after (3,12 months) surgery.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/01
  •   68
  •   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

All patients in our hospital where kyphoplasty is indicated in at least one level (due to osteoporotic and/or pathological vertebral fracture) in the thoracolumbar spine, will be included

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Exclusion Criteria

minors, inability to provide informed consent, pregnancy, additional surgical stabilisation in relation to the same segment, planned open surgery

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Addresses

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    • Klinikum rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Klinikum rechts der Isar der TU München
    • Ms.  PD Dr. med. univ.  Yu-Mi  Ryang 
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Klinikum rechts der Isar der TU München
    • Ms.  Dipl. Ing. Dr. med. univ.  Anna  Rienmüller 
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.