rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study

Medtronic

Status and phase: Completed; Phase 3

Conditions: Degenerative Disc Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00707265

P01-05

Details and patient eligibility

About

The purpose of this study was to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System as a method of facilitating spinal fusion in patients with degenerative disc disease.

Full description

This clinical trial was conducted to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System for posterolateral fusion treatment of patients with symptomatic degenerative disc disease versus the control group of autogenous bone with the CD HORIZON® Spinal System.

The investigational treatment was the open bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System. One investigational implant was placed across two adjacent transverse processes on each side of the spine during the spinal fusion procedure.

The control treatment was the bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.

Enrollment: 463 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Each patient participating in this clinical trial must meet all of the following inclusion criteria:

1. 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 of pain and radiographic studies:
2. Requires fusion of a single level disc space from L1 to S1.
3. 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.
4. If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery.

Exclusion criteria

A patient meeting any of the following criteria is to be excluded from this clinical trial:

1. Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
2. Had previous spinal fusion surgical procedure at the involved level.
3. Requires spinal fusion at more than one lumbar level.
4. Has been previously diagnosed with osteopenia.
5. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
6. Has a history of autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis).
7. Has a history of exposure to injectable collagen or silicone implants.
8. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP 2/CRM implantation.
9. Has received any previous exposure to any/all BMP's of either human or animal extraction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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463 participants in 2 patient groups

Investigational

Experimental group

Description:

Open bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System.

Treatment:

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

Control

Active Comparator group

Description:

The bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.

Treatment:

Device: Autograft/CD HORIZON® Spinal System