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Clinical Trials in Progress

 

Pivotal Study of the Coflex™: An Investigational Non-fusion Spine Stabilization Device

H#06-378

PI/Sub I: Thomas Errico, MD; Jeffrey Spivak, MD; John Bendo, MD; Yong Kim, MD; Jeffrey Goldstein, MD; Michael Murray, MD

Inclusion Criteria:

  • You must be between 40 and 80 years of age.
  • Have moderate severe stenosis
  • Have undergone at least six (6) months of prior conservative care, including one (1) epidural injection, without adequate and sustained symptom relief
  • You must not have had a spinal fusion in the past

Please visit the study website at: www.coflexspinestudy.com

 

A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients with Lumbar Degenerative Disc Disease

H# 06-765

PI/Sub I: Jeffrey Goldstein, MD; John Bendo, MD; Jeffrey Spivak, MD; Yong Kim, MD; Michael Murray, MD

Inclusion Criteria:

  • Has moderate low back pain secondary to lumbar degenerative disc disease at a single level from L2-L5
  • Is 18-70 years of age, inclusive, and is skeletally mature.
  • Has been treated nonoperatively (e.g., bed rest, physical therapy, medications, TENS, manipulation, and/or spinal injections) for a period of at least 6 weeks and not more than 6 months
  • You must not require treatment of degenerative disc disease at more than one lumbar level
  • NO previous surgery at the involved or adjacent spinal levels

 

Trident® TritaniumTM Acetabular Shell Revision Study

H# 06-895

PI/Sub I: Joseph Zuckerman, MD; Fredrick Jaffe, MD

Inclusion Criteria:

  • Males and nonpregnant females, 21-85 years of age at the time of surgery.
  • Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.

 

Open-Label, Multi-Center, Prospective, Clinical Outcomes Data Collection to Evaluate the Equinoxe TM Primary and Fracture Shoulder Study

H# 05-144

PI/Sub I: Young Kwon, MD; Joseph Zuckerman, MD

Inclusion Criterion:

  • Patient is indicated for shoulder joint replacement (primary or fracture)

 

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of Three Injections of SUPARTZ®(Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain Associated with Glenohumeral Osteoarthritis

H# 07-094

PI/Sub I: Laith Jazrawi, MD; Young Kwon, MD; Joseph Zuckerman, MD; Andrew Rokito, MD; Ramesh Gidumal, MD; Joseph Bosco, MD; Robert Meislin, MD

Inclusion Criteria:

  • Males and nonpregnant females, ≥35 years of age, having chronic shoulder pain lasting more than six months, but less than three years
  • Be diagnosed with GH-OA, confirmed by radiographs with GH-OA being the primary source of pain;
  • Have failed one or more of the following conservative treatments: rest, physiotherapy, analgesics, or NSAIDs;
  • Be willing to discontinue all pain medication for at least 24 hours before each visit
  • Have had no modification to his or her current physiotherapy regimen (frequency or schedule including additional new physiotherapies) to treat OA in the trial shoulder in the previous four weeks
  • Have had no modification to his or her current pain medication regimen (dose or schedule including new medications) in the previous four weeks
  • Be able to adhere to a stable regimen (dose and schedule) of pain medication and therapy for up to 6 months after the 1st injection