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

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10024992Term: Lumbar disc disease; 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.

• Registration Number: EUCTR2009-012672-27-NL
• Lead Sponsor: ApaTech Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.
3Aged 18 to 75 years and skeletally mature at time of surgery.
4Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications and/or spinal injections) for a period of six months.
5If of childbearing potential, patient is non-pregnant, non-nursing and agrees not to become pregnant for one year following surgery.
6Is willing to and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.
10Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
11Has 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.
12Has received any previous exposure to any/all BMPs of either human or animal extraction.
13Has a history of allergy to bovine products or a history of general anaphylaxis.
14Has 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).
15Has any disease that would preclude accurate clinical evaluation (e.g., neuromuscular disease, etc.).
16Has 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).
17Has 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.
18Has overt or active bacterial infection, local or systemic, and/or a potential for bacteremia.
19Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
20Has a documented metal allergy or intolerance to titanium alloy or cobalt-chrome-molybdenum alloy.
21Is, in the opinion of the Principal Investigator or Co-Investigators, intellectually unable to co-operate with the study.
22Has chronic or acute renal and/or hepatic failure or prior history of renal or hepatic disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified