INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study

NCT01491542 | Completed DMC

• 1 other identifier: P01-11
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this pilot clinical trial is to evaluate the feasibility of using the investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON® Spinal System) as a method of facilitating spinal fusion in patients with symptomatic 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. Postoperative Oswestry score improvement of at least 15% from preoperative; 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 months

Secondary Outcomes (4)

• General Health Status (SF-36)

  24 months

• Pain Status (back pain, leg pain)

  24 months

• Patient Satisfaction

  24 months

• Patient Global Perceived Effect

  24 months

Study Arms (2)

rhBMP-2 / ACS

EXPERIMENTAL

Device: INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®

Autogenous bone

ACTIVE COMPARATOR

Device: Autogenous Bone / CD HORIZON® Spinal System

Interventions

INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON® DEVICE

The INFUSE® Bone Graft component of the investigational device consists of recombinant human Bone Morphogenetic Protein-2(rhBMP-2) and an absorbable collagen sponge (ACS)carrier. The MASTERGRAFT® Granules will be used as a type of bulking agent to provide compression resistance.

Also known as: Infused Bone Graft, MasterGraft

rhBMP-2 / ACS

Autogenous Bone / CD HORIZON® Spinal System DEVICE

The control will be autogenous bone taken from the iliac crest of the patient and placed bilaterally across two adjacent transverse processes and used in conjunction with the CD HORIZON® Spinal System.

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 \[leg, back, or symptoms in the sciatic nerve distribution\], functional deficit and/or neurological deficit) and radiographic studies (e.g.,C T, MRl, X-Ray,etc.) to include one or more of the following:
• instability (defined as angulation ≥ 5° and/or translation ≥ 4mm,based on flexion/extension radiographs);
• osteophyte formation;
• decreased disc height;
• thickening of ligamentous tissue;
• disc degeneration or herniation; and/or
• facet joint degeneration.
• Has preoperative Oswestry score ≥ 30.
• Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932).
• Requires fusion of a single level disc space from L1 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 6 months.
• If of child-bearing potential, patient is non-pregnant,non-nursing,and agrees to use adequate contraception for 1 year following surgery.
• Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

You may not qualify if:

• Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
• Had previous spinal fusion surgical procedure at the involved level or an adjacent level.
• Requires spinal fusion at more than one lumbar level.
• Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
• Has a documented history of osteopenia or osteomalacia.
• Has any of the following that may be associated with diagnosis of osteoporosis (if "Yes" to any of the below risk factors,a dual x-ray absorptiometry (DEXA) scan will be required to determine eligibility.)
• Postmenopausal non-black female over 60 years of age and weighs less than 140 pounds.
• Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
• Male over the age of 70.
• Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture,then the patient is excluded from the study.
• 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.
• 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.

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: April 1, 2003
• Primary Completion: November 1, 2006
• Study Completion: March 1, 2007
• Last Updated: May 17, 2023

Record last verified: 2023-05