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NCT00316121 - A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach

A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach


CSR Summary

Not Available


Primary Citation

Not Available


Data Specification

Not Available


Annotated CRF

Available upon data request approval

Product Info

Generic Name
HEALOS and Leopard Cage
Product Name
HEALOS®
Therapeutic Area
Muscle, Bone, and Cartilage Diseases
Enrollment
138
% Female
60.9%
% White
N/A
Product Class
Orthopedic Device
Sponsor Protocol Number
05-HEALOS-01
Data Partner
Johnson & Johnson
Condition Studied
Degenerative Disc Disease
Mean/Median Age (Years)
48.5

Supporting Documentation

Clinical Study Report
Collected Datasets
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.