TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

Globus Medical

Status: Completed

Conditions: Lumbar Degenerative Disc Disease

Treatments: Device: TRIUMPH® Lumbar Artificial Disc

Study type: Interventional

Funder types: Industry

Identifiers

NCT01198470

G090143

Details and patient eligibility

About

The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Degenerative Disc Disease in one vertebral level between L1 and S1
• Able to understand and sign informed consent
• Had at least 6 months of conservative treatment
• Oswestry Disability Index Score of at least 30 (one a 100 point scale)
• Other inclusion criteria as specified in approved IDE protocol

Exclusion criteria

• Bilateral leg pain
• Back or leg pain of unknown etiology
• Prior fusion surgery or another spinal device implanted at any other lumbar level
• Osteoporosis or osteopenia
• Other exclusion criteria as specified in approved IDE protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

TRIUMPH® Artificial Disc

Experimental group

Description:

Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).

Treatment:

Device: TRIUMPH® Lumbar Artificial Disc