rhBMP-2/CRM/CD HORIZON® Spinal System Pilot Study (2-Level)

NCT01491568 | Completed DMC

• 1 other identifier: P04-07
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the feasibility of using the investigational implant (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral lumbar spinal fusion at two adjacent treatment levels in patients with symptomatic degenerative disc disease.

Conditions

Degenerative Disc Disease

Keywords

symptomatic degenerative disc disease at two levels

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 (4)

• General health status (SF-36)

  24 month

• Pain status (back pain, leg pain)

  24 month

• Patient satisfaction

  24 month

• Patient global perceived effect

  24 month

Study Arms (1)

Investigational

EXPERIMENTAL

Device: rhBMP-2/CRM/CD HORIZON® Spinal System

Interventions

rhBMP-2/CRM/CD HORIZON® Spinal System DEVICE

rhBMP-2/CRM with the CD HORIZON® SpinalSystem

Also known as: Recombinant human bone morphogenetic protein-2

Investigational

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 at two adjacent lumbar levels as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history and radiographic studies to include one or more of the following:
• instability;
• 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) at either treatment level.
• Requires fusion at two adjacent lumbar levels 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 a female of child-bearing potential, patient is non-pregnant and non-nursing and agrees to not become pregnant 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 levels.
• Has had previous spinal fusion surgical procedure(s) at the involved levels.
• Requires spinal fusion at more than two lumbar levels.
• Has a condition that requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs, excluding routine perioperative nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
• Has been previously diagnosed with osteopenia, osteomalacia, or osteoporosis, or has any of the following that may be associated with a diagnosis of osteoporosis. (If "Yes" to any of the criteria below, a dual x-ray absorptiometry \[DEXA\] scan will be required to determine eligibility.)
• Previously diagnosed with osteopenia, osteomalacia, or osteoporosis.
• Postmenopausal non-black female over 60 years of age who weighs less than 140 pounds.
• Postmenopausal female who has sustained a nontraumatic hip, spine, or wrist fracture.
• Male over the age of 70.
• Male over the age of 60 who has sustained a nontraumatic hip or spine fracture. If the level of bone mineral density (BMD) is a T score of -3.5 or lower( i.e., -3.6, - 3.7, etc.) or a T score of -2.5 or lower( i.e., -2.6,
• , etc.) 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.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

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

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 14, 2011
• Study Start: July 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: November 1, 2010
• Last Updated: May 11, 2023

Record last verified: 2023-05