Trial document




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  DRKS00007785

Trial Description

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Title

Non-interventional study (post-marketing clinical follow-up) of lumbar interbody fusion with an EndoLIF® Oblique Cage

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Facilitating the intergrowth of bone of adjacent vertebral bodies has been a standard treatment for degenerative spine disease for decades.

In recent years, surgical techniques and implants have become more and more low-impact. Narrow access routes to the spine have been particularly beneficial, because the patient experiences less discomfort after surgery and a quicker release from the hospital is possible.

These gentler procedures cause less tissue damage, resulting in significantly less pain and a correspondingly better physical quality of life, i.e. physical capacity, than with conventional surgical procedures.

Standard questionnaires (such as visual analog scales, Oswestry Disability Index and SF-12) are used to record the physical quality of life and strength before and after spinal operations.
The EndoLIF ® O-Cage can be installed using a variety of surgical techniques.

The surgeon decides which access route is the most suitable. The most common approaches are the PLIF, TLIF and EndoLIF® techniques.

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Brief Summary in Scientific Language

Brief scientific description
Fusion of vertebrae segments has been a standard in the treatment of degenerative spine disease for decades. In the last few years minimally invasive techniques in spine surgery have become increasingly important1,2. Narrow access routes to the spine have been particularly beneficial, because the patient experiences less discomfort after surgery and a quicker release from the hospital is possible. These gentler procedures continue to cause less tissue damage, resulting in significantly less pain and a correspondingly better post-operative physical quality of life, i.e. physical capacity, than with conventional surgical procedures.



Visual analog scales the Oswestry Disability Index and the SF-12 have become the established ways of rating the physical quality of life and physical capacity. These are valid methods for tracking pain throughout the study allowing comparison of long-term follow-ups.


The EndoLIF® O-Cage can be implanted through various access routes to the disc space. The choice of suitable access route is the responsibility of the surgeon. The most common approaches are the PLIF, TLIF and EndoLIF® techniques.

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Organizational Data

  •   DRKS00007785
  •   2015/02/10
  •   [---]*
  •   no
  •   Approved
  •   2014-653-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   M51.0 -  Lumbar and other intervertebral disc disorders with myelopathy
  •   M43.16 -  [generalization M43.1: Spondylolisthesis]
  •   M51.3 -  Other specified intervertebral disc degeneration
  •   M43.17 -  [generalization M43.1: Spondylolisthesis]
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Interventions/Observational Groups

  •   pre- and post-operative observation is prescribed for patients with degenerative disc disease or spondylolisthesis with indications for vertebral fusion.
    The clinical symptoms, physical quality of life (SF12) and Oswestry (ODI) scores will be recorded.
    Time intervals: immediately prior to surgery; post-OP: 2 weeks, 6 weeks, 6 months, 12 months and 24 months.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoints are postoperative pain patterns, physical quality of life, physical capacity and satisfaction after lumbar interbody fusion with the EndoLIF Oblique Cage.
The above criteria will be rated preoperatively, postoperatively after 2 and 6 weeks, and at 6, 12 and 24 months.
The criteria will be rated using questionnaires (SF12, Oswestry (ODI) and visual analogue scales (VAS)).

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Secondary Outcome

The objective is to report radiological success rates after lumbar interbody fusion with an EndoLIF® Oblique Cage.

Radiological success is defined as evidence measured by computed tomography of a correctly positioned cage, evidence of fusion and that migration has taken place, with no more than usual sintering and without pseudarthrosis.


Achievements will be assessed by means of routinely performed x-rays or CT scans. The timing of radiological examinations will not be stipulated by the study, but performed according to medical indication.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/02/11
  •   52
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patients for whom the clinical indications for implantation of an EndoLIF® O-Cage were the diagnosis of degenerative lumbar disc disease (M51.0 - M51.3) and spondylolisthesis (M43.16 or M43.17).
Age 18 - 75 years

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Exclusion Criteria

• Patients who are unable to give their consent due, e.g. to cognitive impairment.
• Pregnancy
• Active infection
• An allergy to titanium
• Patients with serious conditions (cancer, heart failure NYHA II or worse, diseases which irreversibly lead to stage ASA III and IV, drug or alcohol abuse, known severe blood clotting abnormalities, peripheral occlusive disease ≥ stage IIb, severe polyneuropathy)
• No patient consent, particularly for patients who did not agree to a 24-month study follow-up
• Patients with fractures of the lumbar spine or in adjacent segments
• BMI > 40 kg/m2
• Soft tissue defects in the area of the planned surgical access route
• Serious diseases of the spine (e.g., osteoarthritis, osteopenia, osteoporosis or osteomalacia)
• Increased fracture risk (systemic or local)
• Diseases with a consecutively decreasing fusion rate
• Congenital malformations of the spine

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Addresses

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    • joimax GmbH
    • Mr.  Wolfgang  Ries 
    • Amalienbadstr. 41 / Raumfabrik 61
    • 76227  Karlsruhe
    • Germany
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    • joimax GmbH
    • Mr.  Wolfgang  Ries 
    • Amalienbadstr. 41 / Raumfabrik 61
    • 76227  Karlsruhe
    • Germany
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    • Neurochirurgische Praxis
    • Mr.  Dr.  Bernd  Illerhaus 
    • Heibeckstr. 30
    • 45711  Datteln
    • Germany
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    • Neurochirurgische Praxis
    • Mr.  Dr.  Bernd  Illerhaus 
    • Heibeckstr. 30
    • 45711  Datteln
    • Germany
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Sources of Monetary or Material Support

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    • joimax GmbH
    • Mr.  Wolfgang  Ries 
    • Amalienbadstr. 41 / Raumfabrik 61
    • 76227  Karlsruhe
    • 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.