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

Medtronic

Status: Completed

Conditions: Lumbar Spinal Stenosis

Treatments: Device: X STOP® Interspinous Process Decompression System

Study type: Observational

Funder types: Industry

Identifiers

NCT00534092

LSS-004-LTO

Details and patient eligibility

About

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.

Full description

Evaluate the long term safety and effectiveness of the X-Stop interspinous process decompression system In the patients who received the X-Stop under the IDE. These patients consist of two cohorts to be evaluated: patients who had moderately impaired physical function prior to X-Stop implantation (as determined by a baseline score >2.0 in the physical function (PF) domain of the Zurich claudication questionnaire), and patients who had mildly impaired physical function prior to X-Stop surgery(as determined by a baseline score <=2.0 in the PF domain of the Zurich claudication questionnaire (ZCQ), through the fifth postoperative year. Clinical examination will be performed at each office visit to confirm the absence of neurological complications. X-ray films (AP/lateral views) taken during the fifth postoperative year will, be analyzed to confirm A) maintenance of distraction and B) the absence of radiological evidence of device-related complications. Secondary endpoints will include mean scores from the SF-36, and incidence rates of adverse events, device failures, and secondary surgeries.

Enrollment: 69 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A patient will be admitted into the LTOS program if he/she meets all of the following inclusion criteria:

1. 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.
2. Is willing and able to provide Informed Consent
3. Is willing and able to return to the clinic for a clinical evaluation or complete study questionnaires without a clinic visit.

Exclusion criteria

A patient will not be admitted into the LTOS program if he/she meets any of the following exclusion criteria:

1. Participated in the Pivotal Trial as part of the X STOP group, but the device has been removed.
2. Participated in the CAP or COS programs, but the device has been removed.