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

NCT00534092 | Completed Results

• 1 other identifier: LSS-004-LTO
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar Spinal Stenosis; X STOP

Outcome Measures

Primary Outcomes (1)

• Treatment Success Rates (At ≥ 5 Years)

  Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of \<2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.

  3+ years following first 2 years post-X-STOP implant through IDE study

Secondary Outcomes (3)

• Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)

  Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study

• Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)

  3+ years following first 2 years post-X-STOP implant through IDE study

• Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)

  Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study

Other Outcomes (2)

• Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study

  3+ years following first 2 years post-X-STOP implant through IDE study

• Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study

  3+ years following first 2 years post-X-STOP implant through IDE study

Interventions

X STOP® Interspinous Process Decompression System DEVICE

The X STOP is a titanium implant that fits between the spinous processes of the lumbar spine. It is made from Ti-6AI-4V Eli titanium alloy (ISO 5832/3) and consists of two components: a spacer assembly and a wing assembly.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received implants and completed participation in the Pivotal, CAP, or COS studies and has the implant intact and is willing and able to provide consent and return to the clinic for evaluation or complete study questionnaires.

You may qualify if:

• 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:

• 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.

Sponsors & Collaborators

• Medtronic Spine LLC: lead

Study Sites (5)

St. Mary's Spine Center

San Francisco, California, 94117, United States

Location

Neurological & Spine Associates

Scarborough, Maine, 04074, United States

Location

Greater Baltimore Spine Care

Timonium, Maryland, 21093, United States

Location

Neurological Specialist

Norfolk, Virginia, 23510, United States

Location

University Hospital

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Hsu KY, Zucherman JF, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Cauthen JC, Ozuna RM. Quality of life of lumbar stenosis-treated patients in whom the X STOP interspinous device was implanted. J Neurosurg Spine. 2006 Dec;5(6):500-7. doi: 10.3171/spi.2006.5.6.500.

  PMID: 17176013 BACKGROUND

• Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio ST, Cauthen JC, Ozuna RM. A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1351-8. doi: 10.1097/01.brs.0000166618.42749.d1.

  PMID: 15959362 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Clinical Department
• Organization: Medtronic Spine and Biologics

msbkclinicalresearch@medtronic.com

1800-876-3133

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Study Start: December 1, 2006
• Study Completion: June 1, 2010
• Last Updated: January 5, 2021
• Results First Posted: July 29, 2011

Record last verified: 2015-03

Locations

US (5)