A Pilot Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

NCT01494428 | Completed

• 1 other identifier: C-9703
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.

Conditions

Degenerative Disc Disease

Keywords

symptomatic degenerative disc disease

Outcome Measures

Primary Outcomes (7)

• Severity and Rate of Implant-Associated Adverse Events

  24 month

• Rate of Implant Revision, Removal and Supplemental Fixation Procedures

  24 month

• Incidence of Permanent Adverse Events

  24 month

• Fusion

  Fusion is defined as: 1. Bone observed connecting with the vertebral bodies above and below either through the implants; lateral to or between the implants; or anterior/posterior to the implants. 2. Angulation \< 5°. 3. Translation \< 3mm. 4. Absence of radiolucent lines around more than 50% of either implant.

  24 month

• Disc Height Measurement

  Disc height will be measured postoperative and compared to the preoperative measurement. Maintenance or improvement in disc height will be determined a success.

  24 month

• Pain/Disability Status

  The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score \>= 15

  24 month

• Neurological Status

  Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.

  24 month

Secondary Outcomes (6)

• Nature and Frequency of Adverse Events Not Associated with the Implants

  24 month

• Rate of Reoperation Procedures

  24 month

• Hip (Donor Site) Pain Status

  24 month

• Patient Satisfaction/Quality of Life Status (SF-36)

  24 month

• Pain Status (Numerical Rating Scale)

  24 month

Study Arms (2)

rhBMP-2/ACS

EXPERIMENTAL

Device: rhBMP-2/ACS/allograft bone dowel

Autogenous Bone

ACTIVE COMPARATOR

Device: Autogenous bone/allograft bone dowel

Interventions

rhBMP-2/ACS/allograft bone dowel DEVICE

The rhBMP-2/ACS will be used in conjunction with an allograft bone dowel.

Also known as: Recombinant human bone morphogenetic protein-2

rhBMP-2/ACS

Autogenous bone/allograft bone dowel DEVICE

An allograft bone dowel contains autogenous bone taken from the patient's iliac crest.

Also known as: Autograft

Autogenous Bone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \> 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.

You may not qualify if:

• Had previous anterior spinal fusion surgical 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).
• Has 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 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.
• Is a prisoner.
• Is an alcohol and/or drug abuser.
• Is a tobacco user at the time of surgery.
• Patient 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).
• Patient has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
• Patient has a history of exposure to injectable collagen implants.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 19, 2011
• Study Start: April 1, 1998
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: May 17, 2023

Record last verified: 2023-05