Coflex PS3 Actual Conditions for Use Study

Conditions

• Spinal Stenosis Lumbar

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• coflex® Interlaminar Technology — DEVICE
  Decompression plus coflex® Interlaminar Technology
• Decompression — PROCEDURE
  Decompression alone

Study Details

A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.

Key Dates

Start date

Sep 9, 2019

Status verified

Jan 2024

Primary completion

Sep 30, 2024

Completion

Nov 30, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: The coflex® Interlaminar Technology
  The coflex device was designed to address the clinical needs of spinal stenosis patients by providing stabilization of the affected level without fusion. The coflex is an interspinous process functional dynamic implant designed to impart a stabilizing effect at the treated level(s). The coflex device was approved by FDA in 2012.
• Active Comparator: Decompression
  Lumbar decompression back surgery is when a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed to give the nerve root more space and provide a better healing environment.

Primary Outcome Measure

coflex performance compared to IDE [ Time Frame: 24and 60 Months ]

Central Contacts

• Laura Henderson
  406-813-4107
  [email protected]
• Isabella Rosales
  406-924-5884
  [email protected]

Locations (19)

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