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Interspinous Process Implant
1 for Lower Back Pain
Phase 3
Waitlist Available
Research Sponsored by Zimmer Spine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must meet all inclusion
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
Eligible Conditions
- Lower Back Pain
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To provide a safety cohort for the Prospective, Multi-center, Randomized, Active-Controlled Study of the Wallis System for the Treatment of Mild to Moderate Degenerative Disc Disease of the Lumbar Spine
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
Interspinous process and dynamic stabilization
Group II: 2Active Control1 Intervention
Conservative Care
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Who is running the clinical trial?
Zimmer SpineLead Sponsor
1 Previous Clinical Trials
340 Total Patients Enrolled
Zimmer BiometIndustry Sponsor
373 Previous Clinical Trials
67,133 Total Patients Enrolled
Frequently Asked Questions
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