Study Phase 3

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

  • PDF icon for CSR Summary CSR Summary Not Available
  • Globe symbol for NCT Number NCT00316121
  • Notebook for Primary Citation Primary Citation Not Available
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameHEALOS and Leopard CageProduct NameHEALOS®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment138% Female60.9%% WhiteN/A
Product ClassOrthopedic DeviceSponsor Protocol Number05-HEALOS-01Data PartnerJohnson & JohnsonCondition StudiedDegenerative Disc DiseaseMean/Median Age (Years)48.5

Supporting Documentation

  • Collected Datasets Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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.