TerminatedNot Applicable

A Pivotal Study of rhBMP-2/ACS/INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

67 participantsStarted 1999-03

Plain-language summary

The purpose of this clinical trial is to assess the safety and effectiveness of the rhBMP-2/ACS/INTER FIX™ device as compared to the autograft/INTER FIX™ device in patients with symptomatic degenerative disease.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, MRI, 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 L2 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 spinal fusion surgical procedure at the involved level.
✕. Has spinal instrumentation (which will not be removed) stabilizing the involved level.
✕. Has a condition which 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.
✕. 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

Neurological Status

Timeframe: 24 month

Trial details

NCT IDNCT01491464

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2002-09

View on ClinicalTrials.gov More Degenerative Disc Disease trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, MRI, 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 L2 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 spinal fusion surgical procedure at the involved level.
✕. Has spinal instrumentation (which will not be removed) stabilizing the involved level.
✕. Has a condition which 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.
✕. 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.