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

NCT01494493 | Terminated DMC

• 1 other identifier: P00-01
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Degenerative Disc Disease

Keywords

symptomatic degenerative disc disease

Outcome Measures

Primary Outcomes (1)

• Overall success

  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."

  24 month

Secondary Outcomes (5)

• Disc Height Measurement

  24 month

• General Health Status (SF-36)

  24 month

• Back and Leg Pain Status (Numerical Rating Scale)

  24 month

• Patient Satisfaction

  24 month

• Patient Global Perceived Effect

  24 month

Study Arms (2)

rhBMP-2/ACS

EXPERIMENTAL

Device: rhBMP-2/ACS/allograft bone dowel

Autogenous Bone

ACTIVE COMPARATOR

Procedure: Autogenous bone/allograft bone dowel

Interventions

rhBMP-2/ACS/allograft bone dowel DEVICE

The rhBMP-2/ACS 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 PROCEDURE

An allograft bone dowel containing 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 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.
• Is a prisoner.
• Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
• Is a tobacco user at the time of surgery.
• 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).
• Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).

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: September 1, 2000
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: May 17, 2023

Record last verified: 2023-05