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

NCT01491464 | Terminated

• 1 other identifier: C-9806
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Degenerative Disc Disease

Keywords

symptomatic degenerative disc disease

Outcome Measures

Primary Outcomes (3)

• Fusion

  Fusion is defined as: 1. Evidence of bridging trabeculae. 2. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs as determined by superimposing the two views, one upon the other. b. Less than 5° difference in angular motion between flexion and extension as seen on lateral flexion/extension radiographs. 3. No evidence of radiolucency surrounding greater than 50% of either device.

  24 month

• Pain/Disability Status

  The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success for each individual patient 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)

• Hip (Donor Site) Pain

  24 month

• Disc Height Measurement

  24 month

• General Health Status (SF-36)

  24 month

• Pain Status (back pain, leg pain)

  24 month

• Patient Satisfaction

  24 month

Study Arms (2)

rhBMP-2/ACS

EXPERIMENTAL

Device: rhBMP-2/ACS/INTER FIX™

Autogenous bone

ACTIVE COMPARATOR

Device: Autogenous bone/INTER FIX™

Interventions

rhBMP-2/ACS/INTER FIX™ DEVICE

The INTER FIX™ device containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS).

Also known as: recombinant human Bone Morphogenetic Protein-2

rhBMP-2/ACS

Autogenous bone/INTER FIX™ DEVICE

The INTER FIX™ device 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, MRI, X-Ray, etc.) to include one or more of the following:
• instability (defined as angular motion \>=5° and/or translation \>= 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 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.

You may not qualify if:

• 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.
• Has a documented titanium alloy allergy or intolerance.
• 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 usage.
• 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).

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 14, 2011
• Study Start: March 1, 1999
• Primary Completion: September 1, 2002
• Study Completion: September 1, 2002
• Last Updated: May 17, 2023

Record last verified: 2023-05