A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis

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DePuy Synthes

Status and phase

Terminated
Phase 3

Conditions

Spinal Stenosis

Treatments

Device: Interspinous Process Distraction Device
Device: Interspinous Spacer device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00697827
INSP01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.

Enrollment

44 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 50 years in age
  • Leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion such as when sitting in a chair.
  • Zurich Claudication Questionnaire Score ≥ 2.0,
  • Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis
  • Has completed at least 6 months conservative therapy

Exclusion criteria

  • Axial back pain only without leg/buttock/groin pain
  • Has had any prior lumbar spine surgery at any level
  • Significant scoliosis, defined as Cobb angle > 10°
  • Spondylolisthesis > Grade 1 or isthmic spondylolisthesis at affected level
  • Osteoporosis
  • Morbid obesity, defined as BMI > 40 kg/m2

Trial design

44 participants in 2 patient groups

1
Experimental group
Description:
In-Space
Treatment:
Device: Interspinous Spacer device
2
Active Comparator group
Description:
X STOP
Treatment:
Device: Interspinous Process Distraction Device

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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