Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
A Pilot Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease
1 other identifier
interventional
27
0 countries
N/A
Brief Summary
The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients with symptomatic degenerative disc disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 1999
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 12, 2011
CompletedFirst Posted
Study publicly available on registry
December 19, 2011
CompletedMay 17, 2023
May 1, 2023
3.8 years
December 12, 2011
May 16, 2023
Conditions
Keywords
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 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 (7)
Neurological Status Success
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
- +2 more secondary outcomes
Study Arms (3)
rhBMP-2/BCP
EXPERIMENTALrhBMP-2/BCP/TSRH® Spinal System
EXPERIMENTALAutograft/TSRH® Spinal System
ACTIVE COMPARATORInterventions
The rhBMP-2/BCP device component consists of recombinant human Bone Morphogenetic Protein-2 ( rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, the TSRH® Spinal System.
The control device will be autogenous bone from the iliac crest of the patient used in conjunction with the TSRH® spinal System.
Eligibility Criteria
You may qualify if:
- Has degenerative disc diseases 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° and/or translation \> 4 mm, 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.).
- 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 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:
- Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade1 or less spondylolisthesis at the involved level.
- Had previous spinal fusion surgical procedure at the involved level.
- Require spinal fusion at more than one lumbar 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
May 1, 1999
Primary Completion
March 1, 2003
Study Completion
March 1, 2003
Last Updated
May 17, 2023
Record last verified: 2023-05