CompletedNot Applicable

Clinical Study of rhBMP-2/BCP With the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

197 participantsStarted 1999-08

Plain-language 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.

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 \>= 30.
✓. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's classification (Meyerding HW, 1932).
✓. Has one or two adjacent levels from L1 to S1 requiring fusion.
✓. 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, 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 spondylolisthesis at the involved levels.
✕. Had previous spinal fusion surgical procedure at the involved levels.
✕. Has a condition that requires postoperative medications that interfere with fusion, such as steroids.
✕. Has been previously diagnosed with 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 grossly obese, i.e., weight \> 40% over ideal for their age and height.
✕. Has fever ( temperature \> 101°F oral) at the time of surgery.

What they're measuring

Fusion

Timeframe: 24 month

Pain/Disability Status

Timeframe: 24 month

Trial details

NCT IDNCT01494454

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-11

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