E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We will investigate if the use of Inductos in a intervertebral cage will provide us with better and or faster fusion rates. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Is there a faster and higher fusion ratio in a group of patients in which the intervetebral cage is filled with Inductos in comparison with patients where the cage is filled up with autologous bone graft. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Skeletally mature to 70 years of age.
Subject is indicated for posterior fusion at one, two, or three levels from L1 to S1. Subject has a one or more of the following diagnoses supported by MRI, and/or CT Scan, and/or Plain X-rays, and/or Discography and physical examination performed by the Investigator : Degenerative Disc Disease Internal Disc Disruption Spinal Stenosis Herniated Nucleus Pulposus Spondylolisthesis (Isthmic-Lytic or Degenerative) Grade I or Grade II only Spondylolysis Failed Lumbar Laminectomy Syndrome
Subject has no prior fusion attempts in the lumbar spine.
Has experienced pain with or without functional deficit and/or neurologic deficit for a minimum three month period of time prior to surgery.
Has failed to respond to non-operative treatment modalities for minimum three month period of time prior to surgery.
Has normal bleeding parameters.
Subject signs the approved Informed Consent Form.
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E.4 | Principal exclusion criteria |
Pregnant at time of surgery or plans to become pregnant within 2 years following surgery.
Number of levels to be fused are greater than 3.
Subject has a lumbar spine deformity, i.e. scoliosis, kyphosis, flat back, ankylosing spondylitis
Will not be available or will not make self available for follow-up visits in accordance with the protocol to at least 24 months.
Currently implanted with a posterior instrumentation system.
Mentally incompetent or prisoner.
Subject is being treated with investigational devices for the same disorder.
Active localized or systemic infection.
Past spinal infection.
Presence of disease entity or condition which precludes the possibility of bony fusion (i.e. metastatic cancer, long-term use of steroids, etc..).
Is unable to undergo autologous grafting procedure (due to insufficient bone stock, osteopenia, or for other reasons).
Has an immunosuppressive disorder.
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E.5 End points |
E.5.1 | Primary end point(s) |
Two years after surgery, through clinical, anamnestic and radiological investigation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Two years after surgery twhe patient will undergo radiological and clinical investigation. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |