Clinical Study of rhBMP-2/BCP With the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

NCT01494454 | Completed DMC

• 1 other identifier: C-9807
• Study Type: interventional
• Target: 197
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal System in treatment of the patients with degenerative disc disease.

Conditions

Degenerative Disc Disease

Keywords

Lumbar degenerative disc disease

Outcome Measures

Primary Outcomes (2)

• Fusion

  Fusion is defined as: 1. Evidence of bridging trabecular bone. 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 the lateral flexion/extension radiographs; 3. Absence of radiolucent lines completely through the fusion mass.

  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

Secondary Outcomes (6)

• Neurological status

  24 month

• Hip (Donor Site) pain

  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/BCP

EXPERIMENTAL

Device: rhBMP-2/BCP/TSRH® or rhBMP-2/BCP/CD HORIZON® Spinal System

Autograft

ACTIVE COMPARATOR

Device: Autograft/TSRH® or autograft/CD HORIZON® Spinal System.

Interventions

rhBMP-2/BCP/TSRH® or rhBMP-2/BCP/CD HORIZON® Spinal System DEVICE

rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, either the TSRH® Spinal System or CD HORIZON® Spinal System.

Also known as: Recombinant human bone morphogenetic protein

rhBMP-2/BCP

Autograft/TSRH® or autograft/CD HORIZON® Spinal System. DEVICE

Either the TSRH® Spinal System or the CD HORIZON® Spinal System with autogenous bone taken from the patient's iliac crest.

Also known as: Autogenous bone graft

Autograft

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° 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 \>= 30.
• Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's classification (Meyerding HW, 1932).
• Has one or two adjacent levels from L1 to S1 requiring fusion.
• 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, 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 spondylolisthesis at the involved levels.
• Had previous spinal fusion surgical procedure at the involved levels.
• Has a condition that 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 or prior history of malignancy (except for basal cell carcinoma of the skin).
• 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 that may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery ( e.g., NSAIDS, steroids or methotrexate).

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: 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: August 1, 1999
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 17, 2023

Record last verified: 2023-05