EUCTR2009-012672-27-NL
Active, not recruiting
Not Applicable
A prospective, randomised study comparing the use of Actifuse™ ABX synthetic bone substitute with INFUSE® in patients requiring posterolateral instrumented lumbar fusion with interbody fusion also referred to as: APPRAISE T1 (A Prospective PLF Randomised Actifuse InfuSe Evaluation Trial 1) - APPRAISE T1
ApaTech Limited0 sitesJune 8, 2009
ConditionsProspective 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.MedDRA version: 9.1Level: LLTClassification code 10024992Term: Lumbar disc disease
DrugsInductOs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 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.
- Sponsor
- ApaTech Limited
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
- •2Has a preoperative Oswestry Back Disability Score of 30 or more.
Exclusion Criteria
- •A patient meeting any of the following criteria is to be excluded from this trial:
- •1Has had previous failed attempts at fusion surgery at the involved level(s).
- •2Has a diagnosis of spinal infection tumour or trauma.
- •3Requires surgery at more than two (2\) levels.
- •4Has osteoporosis (excluding osteopenia) as evidenced on plain X\-rays, CT scans (or DEXA scan in cases of doubt).
- •5Is pregnant.
- •6Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
- •7Has 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.
- •8Has a history of autoimmune disease.
- •9Has a history of exposure to injectable collagen implants.
Outcomes
Primary Outcomes
Not specified
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