A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

Medtronic Spinal and Biologics0 sites85 target enrollmentSeptember 2000

ConditionsDegenerative Disc Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: Medtronic Spinal and Biologics
Enrollment: 85
Primary Endpoint: Overall success
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2000

End Date

February 2004

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Spinal and Biologics

Responsible Party

Sponsor

Eligibility Criteria

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:
•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.
•Has preoperative Oswestry score \>
•Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
•Has single-level symptomatic degenerative involvement from L4 to S

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.
•Is mentally incompetent. If questionable, obtain psychiatric consult.
•Has a Waddell Signs of Inorganic Behavior score of 3 or greater.

Outcomes

Primary Outcomes

Overall success

Time Frame: 24 month

A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Oswestry) improvement; 3. maintenance or improvement in neurological status; 4. no serious adverse event classified as implant associated or implant/surgical procedure associated; 5. no additional surgical procedure classified as a "failure."