Lower Back PainNCT01323543
Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine
A study testing Elaspine™ in people with Lower Back Pain, run by Spinelab AG at 5 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Elaspine™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2010to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed and understood the approved Informed Consent form and is able to meet the proposed follow-up and postoperative management program.
- Patient is skeletally mature and between 21 - 80 years of age.
- Patient's pre-operative Body Mass Index (BMI) is ≤ 34.
- Patient's pre-operative Oswestry Disability Index (ODI) is ≥ 30% (≥15 out of 50 points).
- 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).
- Patient has received non-operative treatment for low back pain for > 6 months and is unresponsive.
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- 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.
Who cannot join
- 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.
- Need for more than two-level or two non-contiguous-level surgery in the lumbar spine.
- Patient has more than 50% defective facet joint (half of the articular joint surface) or laminectomy
- Patient is scheduled for another lumbar surgery such as but not limited to a fusion
- Patient has recent vertebral fractures or past fractures which did not heal.
- Patient has known allergies to titanium alloy and polycarbonate urethane (PCU).
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- 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.
- Patient has spondylolysis at the levels to be treated or an adjacent level.
- Patient has a frontal curve in the lumbar spine >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
- 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.)
- Patient has an active infection either systemic or at the local site of intended surgery.
- 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.
- Patients with known malignant diseases or bone tumors.
- Patients with vascular malformations such as abdominal aneurysm.
- 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.
- Patient has cervical myelopathy.
- Patient is pregnant or planning in becoming pregnant in the next 2 years.
- 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
- 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.
- 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.
- Loss of Disk height according to Pfirrmann (> C) or Frymoyer (>3) and or severe spondylosis.
- Patient shows three or more signs of anorganic behaviour (Waddell´s signs).
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Helios Rosmann Klinik
Breisach, Baden-Wurttemberg, 79206
Katholisches Klinikum Marienhof
Koblenz, Rhineland-Palatinate, 56073
Stauferklinikum Schwäbisch Gmünd
Mutlangen, Baden-Wurttemberg, 73557
HSK Dr. Horst-Schmidt-Klinik
Wiesbaden, Hessia, 65199
Switzerland1 site
HUG Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, 1211
About this study
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"
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.
- Conditions
- Lower Back Pain
- Being tested
- Elaspine™
- Keywords
- 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
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elaspine™Device
Implantation of device
| Study group | Role | What they receive |
|---|---|---|
| Elaspine™ | Experimental | Impantation of Elaspine™ device Receives: Device: Elaspine™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
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.)
Measured: 24 months
Performance
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.
Measured: 24 months
Secondary outcomes (3)
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
Measured: 24 months
Changes in neurologic function at two-years post-operatively as compared to the preoperative baseline by motor, sensory, reflexes and straight leg raise
Measured: 24 months
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startAug 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinelab AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UL International GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323543
- Sponsor's protocol ID
- 10k002 PMCS 01
- Status last verified
- Nov 2015
- First submitted
- 24 Mar 2011
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT01323543
- Acronym / sponsor ID
- 10k002 PMCS 01
- Conditions
- Lower Back Pain
- Keywords
- Back Pain,, Back Pains, Low, Low Back Pains, Pain, Low Back, Pains, Low Back, Lumbago, Lower Back Pain, Back Pain, Lower
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Spinelab AGIndustry (pharma, biotech, devices)
- Collaborators
- UL International GmbH
- Study start
- Aug 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elaspine™ | Experimental | Device: Elaspine™Impantation of Elaspine™ device |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient has signed and understood the approved Informed Consent form and is able to meet the proposed follow-up and postoperative management program.
- Patient is skeletally mature and between 21 - 80 years of age.
- Patient's pre-operative Body Mass Index (BMI) is ≤ 34.
- Patient's pre-operative Oswestry Disability Index (ODI) is ≥ 30% (≥15 out of 50 points).
- 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).
Key exclusion criteria (25 listed)
- 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.
- Need for more than two-level or two non-contiguous-level surgery in the lumbar spine.
- Patient has more than 50% defective facet joint (half of the articular joint surface) or laminectomy
- Patient is scheduled for another lumbar surgery such as but not limited to a fusion
- Patient has recent vertebral fractures or past fractures which did not heal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elaspine™Implantation of device | Device | Elaspine™ |
Primary outcome
Safety
Time frame: 24 months
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
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elaspine™ in people with Lower Back Pain, run by Spinelab AG at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.