CompletedNot Applicable

rhBMP-2/CRM/CD HORIZON® Spinal System Pilot Study (2-Level)

29 participantsStarted 2005-07

Plain-language summary

The purpose of this study is to evaluate the feasibility of using the investigational implant (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral lumbar spinal fusion at two adjacent treatment levels in patients with symptomatic degenerative disc disease.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Has degenerative disc disease at two adjacent lumbar levels as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history and radiographic studies to include one or more of the following:
✓. Has preoperative Oswestry score \>= 30.
✓. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding, HW, 1932) at either treatment level.
✓. Requires fusion at two adjacent lumbar levels from L1 to S1.
✓. Is at least 18 years of age, inclusive, at the time of surgery.
✓. Has not responded to non-operative treatment( e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of 6 months.
✓. If a female of child-bearing potential, patient is non-pregnant and non-nursing and agrees to not become pregnant for 1 year following surgery.
✓. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion criteria

✕. Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved levels.
✕. Has had previous spinal fusion surgical procedure(s) at the involved levels.
✕. Requires spinal fusion at more than two lumbar levels.
✕. Has a condition that requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs, excluding routine perioperative nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
✕. Has been previously diagnosed with osteopenia, osteomalacia, or osteoporosis, or has any of the following that may be associated with a diagnosis of osteoporosis. (If "Yes" to any of the criteria below, a dual x-ray absorptiometry \[DEXA\] scan will be required to determine eligibility.)
✕. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
✕. Has overt or active bacterial infection, either local or systemic.
✕. Has a documented titanium alloy allergy or intolerance.

What they're measuring

Overall Success

Timeframe: 24 month

Trial details

NCT IDNCT01491568

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-05

View on ClinicalTrials.gov More Degenerative Disc Disease trials