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