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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spine LLC
ClinicalTrials.gov Identifier:
NCT00534092
First received: September 20, 2007
Last updated: March 23, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Lumbar Spinal Stenosis
Device: X STOP® Interspinous Process Decompression System
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Long-term Outcomes Among Patients With Lumbar Spinal Stenosis Treated With the X STOP® Interspinous Process Decompression System: Five-Year Follow-up of IDE Patient Cohorts

Resource links provided by NLM:


Further study details as provided by Medtronic Spine LLC:

Primary Outcome Measures:
  • Treatment Success Rates (At ≥ 5 Years) [ Time Frame: 3+ years following first 2 years post-X-STOP implant through IDE study ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) [ Time Frame: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study ] [ Designated as safety issue: Yes ]
    ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire ranging from 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score.

  • Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) [ Time Frame: 3+ years following first 2 years post-X-STOP implant through IDE study ] [ Designated as safety issue: No ]
    ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores <2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction.

  • Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) [ Time Frame: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study ] [ Designated as safety issue: No ]
    Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary [PCS] and mental component summary [MCS]). Scores for each subdomain and component summary range from 0 "worst" to 100 "best. The change from baseline to the 5 year postoperative visit for each of these domains is presented.


Other Outcome Measures:
  • Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study [ Time Frame: 3+ years following first 2 years post-X-STOP implant through IDE study ] [ Designated as safety issue: Yes ]
    The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other.

  • Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study [ Time Frame: 3+ years following first 2 years post-X-STOP implant through IDE study ] [ Designated as safety issue: Yes ]

Enrollment: 69
Study Start Date: December 2006
Study Completion Date: June 2010
Intervention Details:
    Device: X STOP® Interspinous Process Decompression System
    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.
Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534092

Locations
United States, California
St. Mary's Spine Center
San Francisco, California, United States, 94117
United States, Maine
Neurological & Spine Associates
Scarborough, Maine, United States, 04074
United States, Maryland
Greater Baltimore Spine Care
Timonium, Maryland, United States, 21093
United States, Virginia
Neurological Specialist
Norfolk, Virginia, United States, 23510
United States, Wisconsin
University Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Medtronic Spine LLC
  More Information

Publications:
Responsible Party: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00534092     History of Changes
Other Study ID Numbers: LSS-004-LTO
Study First Received: September 20, 2007
Results First Received: June 2, 2011
Last Updated: March 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Spine LLC:
Lumbar Spinal Stenosis
X STOP

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases

ClinicalTrials.gov processed this record on April 19, 2015