Clinical trial NCT01494454: Clinical Study of rhBMP-2/BCP With the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
Official title: A Clinical Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With Either the TSRH® Spinal System or the CD Horizon® Spinal System for Posterolateral Lumbar Fusion in Patients With DDD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: Lumbar degenerative disc disease
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal System in treatment of the patients with degenerative disc disease.


Eligibility criteria: Inclusion Criteria:

1. Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history ( e.g., pain \[leg, back, or symptoms in the sciatic nerve distribution\], function deficit and/or neurological deficit and radiographic studies (e.g., CT, MRl, X-Ray, etc.) to include one or more of the following:

   * instability (defined as angular motion \>=5° translation \>= 4mm, based on Flex/Ext radiographs);
   * osteophyte formation;
   * decreased disc height;
   * thickening of ligamentous tissue;
   * disc degeneration or herniation; and/or
   * facet joint degeneration.
2. Has preoperative Oswestry score \>= 30.
3. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's classification (Meyerding HW, 1932).
4. Has one or two adjacent levels from L1 to S1 requiring fusion.
5. Is at least 18 years of age, inclusive, at the time of surgery.
6. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months.
7. If female of child-bearing potential, who is not pregnant or nursing, agrees to not become pregnant for 1 year following surgery.
8. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion Criteria:

1. Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 spondylolisthesis at the involved levels.
2. Had previous spinal fusion surgical procedure at the involved levels.
3. Has a condition that requires postoperative medications that interfere with fusion, such as steroids.
4. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
5. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
6. Has overt or active bacterial infection, either local or systemic.
7. Is grossly obese, i.e., weight \> 40% over ideal for their age and height.
8. Has fever ( temperature \> 101°F oral) at the time of surgery.
9. Has a documented titanium alloy allergy or intolerance.
10. Is mentally incompetent. If questionable, obtain psychiatric consult.
11. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
12. Is a prisoner.
13. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
14. Is a tobacco user at the time of surgery.
15. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery ( e.g., NSAIDS, steroids or methotrexate).
16. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
17. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
18. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/BCP implantation.
19. Has received any previous exposure to any/all BMP's of either human or animal extraction.
20. Has a history of severe allergy ( anaphylaxis).
21. Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).

Primary outcomes:
measure: Fusion
timeFrame: 24 month
measure: Pain/Disability Status
timeFrame: 24 month
Secondary outcomes:
measure: Neurological status
timeFrame: 24 month
measure: Hip (Donor Site) pain
timeFrame: 24 month
measure: General health status (SF-36)
timeFrame: 24 month
measure: Pain status (back pain, leg pain)
timeFrame: 24 month
measure: Patient satisfaction
timeFrame: 24 month
measure: Patient global perceived effect
timeFrame: 24 month
Other outcomes:
Locations:
Study officials:
References: