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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01494493
Other study ID # P00-01
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2000
Est. completion date February 2004

Study information

Verified date May 2023
Source Medtronic Spinal and Biologics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 85
Est. completion date February 2004
Est. primary completion date February 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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: - instability( defined as angular motion > 5° and/or translation >= 2-4mm, based on Flex/Ext radiographs); - osteophyte formation; - decreased disc height; - thickening of ligamentous tissue; - disc degeneration or herniation; and/or - facet joint degeneration. 2. Has preoperative Oswestry score > 35. 3. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.). 4. Has single-level symptomatic degenerative involvement from L4 to S1. 5. Is at least 18 years of age, inclusive, at the time of surgery. 6. 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. 7. If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery. 8. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form. Exclusion Criteria: 1. Had previous anterior spinal fusion surgical procedure at the involved level. 2. 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. 3. 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). 4. Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated. 5. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin). 6. Has overt or active bacterial infection, either local or systemic. 7. Is obese, i.e., weight greater than 40% over ideal for their age and height. 8. Has fever (temperature> 101°F oral) at the time of surgery. 9. Is mentally incompetent. If questionable, obtain psychiatric consult. 10. Has a Waddell Signs of Inorganic Behavior score of 3 or greater. 11. Is a prisoner. 12. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse. 13. Is a tobacco user at the time of surgery. 14. Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate). 15. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis). 16. Has a history of exposure to injectable collagen implants. 17. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen. 18. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation. 19. Has received any previous exposure to any/all BMP's of either human or animal extraction. 20. Has a history of allergy to bovine products or a history of anaphylaxis. 21. Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).

Study Design


Intervention

Device:
rhBMP-2/ACS/allograft bone dowel
The rhBMP-2/ACS used in conjunction with an allograft bone dowel.
Procedure:
Autogenous bone/allograft bone dowel
An allograft bone dowel containing autogenous bone taken from the patient's iliac crest.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Spinal and Biologics

Outcome

Type Measure Description Time frame Safety issue
Primary Overall success A patient will be considered an overall success if all of the following conditions are met:
fusion;
pain/disability (Oswestry) improvement;
maintenance or improvement in neurological status;
no serious adverse event classified as implant associated or implant/surgical procedure associated;
no additional surgical procedure classified as a "failure."
24 month
Secondary Disc Height Measurement 24 month
Secondary General Health Status (SF-36) 24 month
Secondary Back and Leg Pain Status (Numerical Rating Scale) 24 month
Secondary Patient Satisfaction 24 month
Secondary Patient Global Perceived Effect 24 month
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