Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by Spinelab AG
Sponsor:
Collaborator:
MDT Medical Device Testing GmbH
Information provided by:
Spinelab AG
ClinicalTrials.gov Identifier:
NCT01323543
First received: March 24, 2011
Last updated: July 1, 2011
Last verified: July 2011
  Purpose

The safety and performance of the Elaspine™ Implant System in the treatment of lower back pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing clinical study (PMCS). The study will be enrolled within Germany and Switzerland in 3-5 clinical centres, including in average 10 patients per centre. The study is conducted in accordance with the Standard ISO 14155, where applicable on clinical investigation of medical devices for human subjects and other legal requirements.


Condition Intervention
Lower Back Pain
Device: Elaspine™

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "Elaspine™ Implant System Post Marketing Clinical Study: A Prospective, Multicentre Study to Evaluate the Safety and Performance of the Elaspine™ System in the Surgical Treatment of Degenerative Lumbar Spine"

Resource links provided by NLM:


Further study details as provided by Spinelab AG:

Primary Outcome Measures:
  • Safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Incidence (including severity) of operative and post-operative complications throughout the first 3 months postoperatively by category (general, operative, post-operative, possibly device related etc.)

  • Performance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Defined as the incidence of device complications and device malfunctions (including severity), as assessed by radiographic evaluation throughout the first 12 months post-operatively. Device malfunctions include, but are not limited to loosening or breakage of the pedicle screws, disassembly of the locking clip, breakage of the rod, pathological motion or stiffness of the segments and disc collapse. Reading of the imaging studies will be centralized at an independent facility.


Secondary Outcome Measures:
  • Changes in function status (ODI), back pain (VAS) and health status (SF-12) at two-years post-operatively will be measured and compared to the preoperative baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Changes in neurologic function at two-years post-operatively as compared to the preoperative baseline by motor, sensory, reflexes and straight leg raise [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Changes in angular range of motion from maximum flexion to extension between preoperative baseline and the two-year postoperative outcome assessed by radiographic imaging (dynamic xrays) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Elaspine™
    Implantation of device
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has signed and understood the approved Informed Consent form and is able to meet the proposed follow-up and postoperative management program.
  2. Patient is skeletally mature and between 21 - 80 years of age.
  3. Patient's pre-operative Body Mass Index (BMI) is ≤ 34.
  4. Patient's pre-operative Oswestry Disability Index (ODI) is ≥ 30% (≥15 out of 50 points).
  5. Patient's pre-operative back pain Visual Analogue Scale (VAS) is >60 (0-100 scale), with or without associated leg pain (leg pain VAS score).
  6. Patient has received non-operative treatment for low back pain for > 6 months and is unresponsive.
  7. Patient has one or more of the following structural abnormalities with imaging studies verifying them at one or two contiguous levels within L1-L5:

    • Discopathy
    • Degenerative disc disease
    • Massive or recurrent disc herniation
    • Non-isthmic spondylolisthesis ≤ Grade 1 (acc. To Meyerding)
    • Spinal stenosis
    • Partially defective facet joints
    • Retrolisthesis according to one of the following definitions (acc. to Ruch, William J.; Literature Reference 21):

      • Complete Retrolisthesis: The body of one vertebra is posterior to both the vertebral body of the segment of the spine above as well as below
      • Stairstepped Retrolisthesis: The body of one vertebra is posterior to the body of the spinal segment above, but is anterior to the one below.
      • Partial Retrolisthesis: The body of one vertebra is posterior to the body of the spinal segment either above or below.

Exclusion Criteria:

  1. Degenerative spondylolisthesis greater than Grade 1 as defined by greater than 25 percent vertebral slip forward over the inferior vertebral body (acc. to Meyerding Classification) or significant segmental instability at or adjacent to intended treatment level.
  2. Need for more than two-level or two non-contiguous-level surgery in the lumbar spine.
  3. Patient has more than 50% defective facet joint (half of the articular joint surface) or laminectomy
  4. Patient is scheduled for another lumbar surgery such as but not limited to a fusion
  5. Patient has recent vertebral fractures or past fractures which did not heal.
  6. Patient has known allergies to titanium alloy and polycarbonate urethane (PCU).
  7. Patient has clinically compromised vertebral body structure and morphology at the lumbar spine due to current or past trauma (or pathological vertebral fracture) or significant endplate incompetence such as Schmorl´s node.
  8. Patient has spondylolysis at the levels to be treated or an adjacent level.
  9. Patient has a frontal curve in the lumbar spine >10°.
  10. Patient has previously been diagnosed osteopenia or metabolic bone diseases or severe osteoporosis - if suspected to be confirmed by bone density being 2.5 SD below normal as assessed using DEXA analysis in:

    • Postmenopausal females if suggested by x-ray or other risk factors
    • Males over the age of 60 that have sustained a non-traumatic hip or spine fracture
  11. Patient is taking medications known to potentially interfere with bone/soft tissue healing, including but not limited to the long term use of corticosteroids. (This is not intended to exclude patients using inhalation medications for asthma.)
  12. Patient has an active infection either systemic or at the local site of intended surgery.
  13. Patient has been diagnosed with hepatitis, rheumatoid arthritis, an autoimmune disease, or AIDS, ARC, or is HIV positive or any other diseases that according to surgeons may have an impact on the outcome of the surgery.
  14. Patients with known malignant diseases or bone tumors.
  15. Patients with vascular malformations such as abdominal aneurysm.
  16. Patient has a progressive neuromuscular disease. Patient has active malignancy within the last 15 years, unless the malignancy was treated with curative intent and there have been no clinical signs or symptoms for at least 5 years.
  17. Patient has cervical myelopathy.
  18. Patient is pregnant or planning in becoming pregnant in the next 2 years.
  19. Patient is currently participating in another investigational study where the endpoints have not yet been achieved. 8/35 Elaspine™ PMCS 01, Clinical Investigation Plan CIP EN Version C, October 1st, 2010 CONFIDENTIAL
  20. Patient has mental illness, and/or diagnosed as clinically depressed or belongs to a vulnerable population (e.g., prisoner, severe drug abuser, developmentally disabled) that would compromise ability to provide informed consent or compliance with follow-up requirements. If suspected to be confirmed by classification according to DSM IV.
  21. Patient has had another surgical procedure(s) within the last 60 days involving general anesthesia or any surgical procedure that might increase the risk of deep vein thrombosis.
  22. Loss of Disk height according to Pfirrmann (> C) or Frymoyer (>3) and or severe spondylosis.
  23. Patient shows three or more signs of anorganic behaviour (Waddell´s signs).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323543

Contacts
Contact: André Kaelin, MD +41 (0) 22 382 47 86 ext 4786 andre.kaelin@hcuge.ch

Locations
Germany
Helios Rosmann Klinik Recruiting
Breisach, Baden-Wuerttemberg, Germany, 79206
Principal Investigator: Michael Pfeiffer, MD         
Sub-Investigator: Nikolaus Michaelis, MD         
Stauferklinikum Schwäbisch Gmünd Recruiting
Mutlangen, Baden-Wuerttemberg, Germany, 73557
Principal Investigator: Roland Rißel, MD         
Sub-Investigator: Andreas Krepsz, MD         
HSK Dr. Horst-Schmidt-Klinik Recruiting
Wiesbaden, Hessia, Germany, 65199
Principal Investigator: Robert Schönmayr, MD         
Sub-Investigator: Olaf Kopetsch, MD         
Katholisches Klinikum Marienhof Recruiting
Koblenz, Rhineland-Palatinate, Germany, 56073
Principal Investigator: Francis C. Kilian, MD         
Sub-Investigator: Heike Schuster-Hulley, MD         
Switzerland
HUG Hôpitaux Universitaires de Genève Not yet recruiting
Geneva, Switzerland, 1211
Contact: André Kaelin, MD    +41 (0) 22 382 ext 47 86    andre.kaelin@hcuge.ch   
Principal Investigator: André Kaelin, MD         
Sub-Investigator: Antonio Faundez, MD         
Sponsors and Collaborators
Spinelab AG
MDT Medical Device Testing GmbH
  More Information

No publications provided

Responsible Party: Holger Anhalt/Project Manager, Spinelab AG
ClinicalTrials.gov Identifier: NCT01323543     History of Changes
Other Study ID Numbers: 10k002 PMCS 01
Study First Received: March 24, 2011
Last Updated: July 1, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Spinelab AG:
Back Pain,
Back Pains, Low
Low Back Pains
Pain, Low Back
Pains, Low Back
Lumbago
Lower Back Pain
Back Pain, Lower
Back Pains, Lower
Lower Back Pains
Pain, Lower Back
Pains, Lower Back
Low Back Ache
Ache, Low Back
Aches, Low Back
Back Ache, Low
Back Aches, Low
Low Back Aches
Low Backache
Backache, Low
Backaches, Low
Low Backaches
Low Back Pain, Recurrent
Recurrent Low Back Pain
Low Back Pain, Postural
Postural Low Back Pain
Low Back Pain, Mechanical
Mechanical Low Back Pain
Low Back Pain, Posterior Compartment

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014