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Artificial Lumbar Disc

Treatment for Degenerative Disc Disease (FLD Trial)

N/A
Waitlist Available
Research Sponsored by AxioMed Spine Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

FLD Trial Summary

This study will look at the result of using the FLD device as an artificial lumbar disc. The study will compare the safety and effectiveness of the FLD artificial lumbar disc to an already approved artificial lumbar disc.

Eligible Conditions
  • Degenerative Disc Disease

FLD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall success will be determined by a composite of measures regarding subject self-assessment of function (disability), low back pain, neurological function and device implantation status.
Secondary outcome measures
The improvement of subject self-assessment of function (disability), low back pain, patient satisfaction, neurological function and device implantation status at the 24 month follow-up compared to baseline.

FLD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
FLD
Group II: ControlActive Control1 Intervention

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Who is running the clinical trial?

AxioMed Spine CorporationLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
2008. "Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00775801.
All > Degenerative Disc Disease
~18 spots leftby Apr 2025
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