Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®

Completed

Conditions studied: Lumbar Spinal Stenosis

In brief

The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS). It is designed to supplement postmarket safety and effectiveness data to be gathered in a Condition of Approval (CoA) study of a population of patients with moderately impaired physical function who elect to undergo X-STOP surgery.

Key facts

Study ID

NCT00534092

Run by

Medtronic Spine LLC

People needed

69

Starts

2006-12-01

Expected to finish

2010-06-01

Last updated by the study team

2021-01-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient will be admitted into the LTOS program if he/she meets all of the following inclusion criteria:
• Completed participation in the Pivotal Trial, CAP, or COS and has the X STOP implant(s) intact at the time of LTOS enrollment; OR is an active CAP/COS participant, has the X STOP implant(s) intact, and has not completed a 24-month follow-up visit in his/her CAP/COS study.
• Is willing and able to provide Informed Consent
• Is willing and able to return to the clinic for a clinical evaluation or complete study questionnaires without a clinic visit.

You may not qualify if…

• A patient will not be admitted into the LTOS program if he/she meets any of the following exclusion criteria:
• Participated in the Pivotal Trial as part of the X STOP group, but the device has been removed.
• Participated in the CAP or COS programs, but the device has been removed.

Where it is running

• St. Mary's Spine Center — San Francisco, California, United States
• Neurological & Spine Associates — Scarborough, Maine, United States
• Greater Baltimore Spine Care — Timonium, Maryland, United States
• Neurological Specialist — Norfolk, Virginia, United States
• University Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.