E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prospective trial participants will have been diagnosed with degenerative disc disease with a treatment option of decompression and Interbody Fusion with Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024992 |
E.1.2 | Term | Lumbar disc disease |
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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 |
The primary objective of this clinical trial is to evaluate the success rates of ACTIFUSE™ ABX and INFUSE® to achieve bone growth and bone fusion. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this clinical trial will be to assess clinical outcome measurements. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Each patient participating in the clinical trial must meet the following inclusion criteria:
1 Has degenerative disc disease of the lumbar spine as indicated by back pain of discogenic/degenerative origin, with or without leg pain, and has one or more of the following conditions as documented by plain X-rays, CT scan or MRI scan: • Modic changes. • High intensity changes in the annulus. • Loss of disc height. • Decreased hydration of the disc. • Canal stenosis with or without spondylotic slip. • Gross facet joint changes requiring fusion for treatment. • Have documented annular pathology by other means. (e.g., with discography). 2 Has a preoperative Oswestry Back Disability Score of 30 or more. 3 Aged 18 to 75 years and skeletally mature at time of surgery. 4 Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications and/or spinal injections) for a period of six months. 5 If of childbearing potential, patient is non-pregnant, non-nursing and agrees not to become pregnant for one year following surgery. 6 Is willing to and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
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E.4 | Principal exclusion criteria |
A patient meeting any of the following criteria is to be excluded from this trial:
1 Has had previous failed attempts at fusion surgery at the involved level(s). 2 Has a diagnosis of spinal infection tumour or trauma. 3 Requires surgery at more than two (2) levels. 4 Has osteoporosis (excluding osteopenia) as evidenced on plain X-rays, CT scans (or DEXA scan in cases of doubt). 5 Is pregnant. 6 Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse. 7 Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g., steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs. 8 Has a history of autoimmune disease. 9 Has a history of exposure to injectable collagen implants. 10 Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen. 11 Has received treatment with an investigational therapy (device and/or pharmaceutical) within 30 days prior to surgery or such treatment is planned during the 24 months following surgery. 12 Has received any previous exposure to any/all BMPs of either human or animal extraction. 13 Has a history of allergy to bovine products or a history of general anaphylaxis. 14 Has a history of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget’s disease, renal oseodystrophy, Ehlos-Danlos syndrome or osteogenesis imperfecta). 15 Has any disease that would preclude accurate clinical evaluation (e.g., neuromuscular disease, etc.). 16 Has a primary diagnosis of a spinal disorder other than degenerative disc disease or other conditions as set out in “inclusions” above at the involved level(s). 17 Has a condition that requires postoperative medications that interfere with fusion, such as steroids or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative non-steroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation. 18 Has overt or active bacterial infection, local or systemic, and/or a potential for bacteremia. 19 Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin). 20 Has a documented metal allergy or intolerance to titanium alloy or cobalt-chrome-molybdenum alloy. 21 Is, in the opinion of the Principal Investigator or Co-Investigators, intellectually unable to co-operate with the study. 22 Has chronic or acute renal and/or hepatic failure or prior history of renal or hepatic disease.
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E.5 End points |
E.5.1 | Primary end point(s) |
Fusion, defined as evidence of bridging trabecular bone present at 1 year as assessed by CT scan (grade 4 or 5) as well as a determination of no motion as assessed by plain radiographs.
CT scans will be graded as follows:
1. Demonstrating no fusion on either side (grade 1) 2. Partial or limited unilateral fusion (grade 2) 3. Partial or limited bilateral fusion (grade 3) 4. Solid unilateral fusion (grade 4) 5. Solid bilateral fusion (grade 5)
No motion defined as: a. No more that 3 mm difference in translation on the lateral flexion/extension radiographs as determined by superimposing the two views one upon the other. b. Less than 5 degrees difference in angular motion between flexion and extension.
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Patients + independent radiographic reviewers will be blinded, surgeons will not be blinded. |
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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 | No |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |