TerminatedNot Applicable

Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

85 participantsStarted 2000-09

Plain-language summary

The purpose of this clinical trial is to evaluate the implant (rhBMP-2/ACS/allograft bone dowel) as a method of facilitating spinal fusion in patients with degenerative disc disease.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:
✓. Has preoperative Oswestry score \> 35.
✓. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
✓. Has single-level symptomatic degenerative involvement from L4 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 at least 6 months.
✓. If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
✓. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion criteria

✕. Had previous anterior spinal fusion surgical procedure at the involved level.
✕. Has posterior spinal instrumentation (which will not be removed) stabilizing the involved level or has had a previous posterior lumbar interbody fusion procedure at the involved level.
✕. Has a condition which requires postoperative medications that interfere with fusion, such as steroids or nonsteroidal antiinflammatory drugs (this does not include low dose aspirin for prophylactic anticoagulation or perioperative steroids).
✕. Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
✕. 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.
✕. Is obese, i.e., weight greater than 40% over ideal for their age and height.
✕. Has fever (temperature\> 101°F oral) at the time of surgery.

What they're measuring

Overall success

Timeframe: 24 month

Trial details

NCT IDNCT01494493

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-02

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