N/A
N=69
Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®
Lumbar Spinal Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT00534092 ↗Enrolled (actual)
69
Serious AEs
21.7%
Results posted
Jul 2011
Primary outcome: Primary: Treatment Success Rates (At ≥ 5 Years) — 40.8; 30.8; 38.7; 53.8 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- X STOP® Interspinous Process Decompression System (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Medtronic Spine LLC
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success Rates (At ≥ 5 Years) |
40.8; 30.8; 38.7; 53.8; 84.6; 60.0 | — |
| SECONDARY Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) |
-0.8; -1.0; -0.8; -1.0; -0.4; -0.8 | — |
| SECONDARY Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) |
1.7; 1.5; 1.6 | — |
| SECONDARY Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) |
23.4; 31.1; 25.0; -5.4; -0.9; -4.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00534092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.