A Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients W… (NCT01491425) | Clinical Trial Compass
CompletedNot Applicable
A Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
134 participantsStarted 1998-11
Plain-language summary
This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE® Device using laparoscopic surgical technique as compared to an historical control group treated with Autogenous Bone/LT-CAGE® Device using an open surgical technique in patients with symptomatic 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.