Zurich Claudication Questionnaire Scores Research Articles

Interspinous process devices for the treatment of neurogenic intermittent claudication: a systematic review of randomized controlled trials.

The aim of this study is to compare interspinous process device (IPD) implantation to other methods for the treatment of neurogenic intermittent claudication (NIC). PubMed and Cochrane library were searched in December 2014. Randomized controlled trials (RCTs) comparing IPD implantation and nonoperative therapy or laminectomy with/without spinal fusion for the treatment of NIC due to spinal stenosis or low-grade degenerative spondylolisthesis were included. Meta-analysis and qualitative analysis were conducted as appropriate. Eleven articles (eight RCTs) were included, with two having high risk of bias. These RCTs were divided into three groups according to control cohort interventions: IPD implantation was compared with nonoperative treatment (group 1, n = 3), laminectomy (group 2, n = 3), and laminectomy associated with instrumented spinal fusion (group 3, n = 2). Group 1 studies reported better Zurich Claudication Questionnaire (ZCQ) scores for the IPD group. In group 2, two studies reported comparable ZCQ scores and one revealed comparable visual analog scale (VAS) and Oswestry Disability Index (ODI) scores; pooled analysis showed a higher reoperation rate in patients treated with IPD. In group 3, one study found that more patients in IPD group gained more than 25% improvement in VAS and ODI, with lower complication rate; the other reported better ZCQ scores in the IPD group and comparable complication and reoperation rates. IPD implantation is more effective than the other methods, but not superior to laminectomy in treating NIC.

Does the wait for lumbar degenerative spinal stenosis surgery have a detrimental effect on patient outcomes? A prospective observational study.

Waits for elective spine surgery are common in Canada. We examined whether a prolonged wait for surgery for lumbar degenerative spinal stenosis was detrimental to outcome. In this prospective observational study, we enrolled 166 consecutive patients referred to our centre for treatment of lumbar degenerative spinal stenosis between 2006 and 2010. Outcome measures were assessed at referral, preoperatively and until 24 months postoperatively. Primary outcome measures were the physical and mental component summary scores of the 36-Item Short-Form Health Survey and the Oswestry Disability Index. Secondary outcome measures included the symptom severity scale of the Zurich Claudication Questionnaire, a numeric rating scale for back and leg pain, and patient satisfaction with treatment. Wait time was defined as the time from referral to surgery. The follow-up rate at 2 years was 85%. The median wait time was 349 days. All health-related quality of life measures deteriorated during the waiting period, but there was no significant correlation between wait time and magnitude of the change in outcome measure. At 6 months postoperatively, the Pearson correlation was significantly positive between wait time and change in disability (r = 0.223), Zurich Claudication Questionnaire score (r = 0.2) and leg pain score (r = 0.221). At 12 months, the correlation remained significant for change in disability (r = 0.205) and was significant for change in mental well-being (r = -0.224). At 12 months, patients with a shorter wait (≤ 12 months) showed greater improvement in mental well-being (mean difference in change [and 95% confidence interval (CI)] 5.7 [1.4-9.9]) and decrease in disability (-9.3 [95% CI -15.1 to -3.6]) and leg pain (-1.6 [95% CI -3.0 to -0.3]). There were no statistically significant differences in outcome or patient satisfaction with treatment between those with shorter and longer waits at 24 months. Patients awaiting spinal surgery experienced deterioration in health-related quality of life irrespective of the length of wait time. However, longer waits were associated with a delay in recovery during the first year after surgery.

A report on the early results of the BacJac interspinous distraction device: a prospective study in patients with lumbar spinal stenosis

Aims: This is a report on the early clinical outcome of the BacJac interspinous distraction device in patients with lumbar spinal stenosis. Materials and methods: This is a prospective study on a group of patients who underwent surgery from February 2010 to December 2012. There were 21 consecutive patients who had insertion of a BacJac. Data prospectively recorded included Visual Analogue Scores for leg pain (VL), back pain (VB), the Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and walking distance (WD). Scores were recorded preand postoperatively and at final review. The follow-up period varied from 6 to 40 months. Results: We found all clinical outcome measures improved following surgery. Mean scores for VL improved from 76 to 27, for VB from 49 to 24, and for ODI from 42 to 26 at final follow-up. There were also improvements noted in ZCQ scores and patient-reported WD. We also noted a high rate of osteolysis (76%) around the implant at 1 year from insertion. Conclusion: This small prospective study suggests that there is a role for the use of the BacJac interspinous distraction devices in selected patients. Osteolysis around the implant remains an issue although this did not appear to compromise the early outcome in this study.

Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial

Objective To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis....

Two-Year Results of X-Stop Interspinous Implant for the Treatment of Lumbar Spinal Stenosis

Prospective Observational Study. To prospectively assess the clinical outcome of patients treated for symptomatic spinal stenosis with the X-stop device. The X-stop device is used in the treatment of symptomatic lumbar spinal stenosis. The preliminary results of this study of 40 patients at 1 year were published in 2007. The 2-year results of 57 patients are reported in this paper. Zucherman et al report 60% significant improvement at 1 year and 48.4% at 2 years. Fifty-seven consecutive patients with radiologically confirmed lumbar spinal stenosis were enrolled and treated with the X-stop device. The device was implanted at a maximum of 2 affected levels. Clinical response was evaluated with the Zurich Claudication Questionnaire (ZCQ), Oswestry Disability Index, and Short Form-36 questionnaires preoperatively and 6, 12, and 24 months postoperatively. Of the 57 patients enrolled, 54 completed the ZCQ questionnaire at 1 year and 46 patients at 2 years. Clinically significant improvement was attained by 65% at 1 year and 57% at 2 years and 70% were satisfied with the outcome of the surgery. Single level and double level insertions did not have significant difference in clinical outcome. This study demonstrates with the use of ZCQ scores as primary outcome measures that improved clinical outcomes are maintained at 2 years after X-stop implantation.

Lumbar spinal stenosis treatment with aperius perclid interspinous system

PurposeThe purpose of this study is to report clinical outcome and imaging changes of percutaneous Aperius stand-alone implant in patients with degenerative lumbar spinal stenosis and neurogenic intermittent claudication, which did not respond to conservative treatment.MethodBetween January 2008 and July 2010, 37 patients (20 males and 17 females) with mean age of 64.3 years underwent surgery for the onset of claudicatio spinalis with Aperius PercLID interspinous device (Medtronic). In all patients, the diagnosis was: foraminal stenosis, in one case (2.7 %) it was associated to a degenerative anterior listhesis (I grade), in three cases (8.1 %) it was associated to an intraforaminal disc herniation. The mean follow-up was of 18 months (range 2–35 months). The patients were evaluated through the Oswestry disability index, Zurich Claudication Questionnaire (ZCQ), VAS scales. In all cases were obtained preoperative and in postoperative radiographs and magnetic resonance imaging.ResultsThe VAS score decreased significantly after surgery: the patients presented a mean VAS of seven preoperatively and two postoperatively (p < 0.001).The ZCQ score significantly decreased postoperatively, with an average reduction of 21.89 % (p < 0.001).The ODI score as well showed a significant reduction postoperatively of an average 26.09 % (p < 0.001).ConclusionDespite of the brief follow up, the preliminary results are encouraging, showing a significantly decrease of the disability parameters, a marked improvement of the function with the vanishing of the claudicatio spinalis and the following increase of the free interval during the walk. Aperius PercLID system seems to offer an alternative to the traditional decompression surgery.

Interspinous Process Implantation for the Treatment of Neurogenic Intermittent Claudication

BackgroundLumbar spinal stenosis (LSS) is a disabling medical condition in which narrowing of the spinal canal compresses the spinal cord and nerves causing a condition called neurogenic intermittent claudication (NIC). Decompressive spine surgery is the standard of care for patients who fail to improve with conservative management. However, oftentimes, patients who suffer from LSS are elderly individuals with multiple co-morbidities who cannot withstand the risks of decompressive surgery. X-Stop, a novel and minimally invasive FDA approved interspinous process implant, has come into the scene as an alternative to decompressive surgery, and can be inserted under local anesthetic with minimal blood loss.ObjectivesDespite its growing support in medical literature as an effective and conservative treatment of NIC, X-Stop remains a fairly new form of treatment. The aim of this study is to assess the clinical efficacy of its use.Patients and MethodsFifty consecutive patients with at least two-year follow-up had a confirmed diagnosis of NIC secondary to LSS by computed tomography or magnetic resonance imaging (MRI) and subsequently received an X-Stop implant. Subjects’ ages ranged from 64 to 95 with a mean age of 79, while the gender distribution comprised of 23 males and 27 females. Zurich Claudication Questionnaire (ZCQ) was used to assess patient outcome measures in three domains: physical function (PF), patient satisfaction (PS), and symptom severity (SS). The visual analog scale (VAS) was used to assess trends in pain with a scale from 0–10, with 0 defined as “pain-free” and 10 designated as “the worst pain imaginable”.ResultsCompared to pre-op scores, PF, SS, and VAS scores for back, buttock and leg pain had a significant mean decrease at 6, 12, 24 months post-op (P < 0.05). Based on the ZCQ and VAS scores, a success rate of 79% (27.34), 78% (30.38) and 74% (17.23) were achieved at six months, 12 months, and 24 months respectively.ConclusionsX-Stop is a safe and effective treatment for NIC that provides marked relief of symptoms with sustained beneficial outcomes at up to two years of follow-up. In addition, X-Stop permits implantation under local anesthetic with minimal blood loss”.

Degenerative lumbar spinal stenosis with neurogenic intermittent claudication and treatment with the Aperius PercLID System: a preliminary report

The aim of this study was to evaluate whether clinical improvement is noticeable after a minimally invasive procedure such as that used with the Aperius PercLID System in patients with degenerative lumbar spinal stenosis (DLSS) and neurogenic intermittent claudication (NIC). The patients were treated with the aforementioned system at 3 different centers. The initial requirement to be included in the study was a minimum follow-up of 12 months. The authors studied 40 cases of DLSS in patients with NIC (age 72.7 +/- 8.08 years). Symptom severity, physical function, quality of life, and self-rated pain were assessed preoperatively and at the 12-month follow-up using the Zurich Claudication Questionnaire (ZCQ) and a visual analog scale. The procedure was conducted under spinal (35 patients) or local (5 patients) anesthesia, using biplanar fluoroscopy for visualization. Single-level treatment was performed in 28 patients and 2-level treatment was performed in 12 patients. Based on time recordings in 24 cases, the mean procedural time was 19.9 +/- 5.0 minutes. The mean pain visual analog scale score improved significantly from 8.1 +/- 2.19 at baseline to 3.44 +/- 2.89 at the 1-year follow-up. The ZCQ score for patient satisfaction showed 90% of the patients being satisfied with the procedure. The mean rates of improvement in ZCQ score for symptom severity and physical function at 1 year were 38.7 +/- 33.3% and 33.8 +/- 29.7%, respectively, and both proved to be statistically significant. Most improvement was seen in mobility, pain/discomfort, and ability for self-care. In this preliminary study, the Aperius system provided clinically significant improvement after 1 year of follow-up in patients older than 65 years with DLSS and NIC.

Aperius PercLID Stand Alone Interspinous System for the Treatment of Degenerative Lumbar Stenosis

This study is a retrospective clinical investigation of a new interspinous device implanted via a totally percutaneous technique involving 152 consecutive patients. Evaluation of the efficacy of the percutaneous Aperius stand alone implant in patients with degenerative lumbar stenosis and neurogenic intermittent claudication that did not respond to conservative treatment. The use of interspinous implants grew markedly during the last years. Nowadays, many extension controller devices are positioned through minimally invasive procedures. From January 2007 to February 2008, 152 consecutive patients with neurogenic intermittent claudication were treated with Aperius PercLID system. Under a local anesthesia, a 1.5 cm skin incision was performed. Trocars for interspinous space distraction were positioned using fluoroscopy guidance. A suitable size Aperius was positioned and released in the interspinous space with a totally percutaneous technique. In 145 patients 1 level was treated, whereas 6 patients received 2 level treatments, and 1 patient received 3 level treatments. The levels treated were L4-L5 in 125 patients (78.2%), L3-L4 level in 26 patients (16.3%), L2-L3 level in 5 patients (3.1%), L5-S1 level in 3 patients (1.8%), and L1-L2 level in 1 patient (0.6%). The surgical time ranged from 8 to 14 minutes for 1 single level. No adverse events were noted. In 1 case (0.6%), Aperius was not implanted because of hypertrophic facet joints that have hindered the correct insertion of the device; we observed only 2 cases of therapeutic failure (1.3%). There was a significant improvement in the Visual Analog Scale and Zurich Claudication Questionnaire scores for low-back and leg pain and for neurogenic claudication. These results indicate that Aperius PercLID system offers an easy, safe, and effective treatment for patients with lumbar degenerative stenosis. Thus, this device system treatment represents a valid alternative to the traditional surgical techniques.

The X STOP Device

Object. Interspinous process decompression (IPD) theoretically relieves narrowing of the spinal canal and neural foramen in extension and thus reduces the symptoms of neurogenic intermittent claudication (NIC). The purpose of this study was to compare the efficacy of IPD with nonoperative treatment in patients with NIC secondary to degenerative spondylolisthesis. Methods. The authors conducted a randomized controlled study in patients with NIC; they compared the results obtained in patients treated with the X STOP IPD device with those acquired in patients treated nonoperatively. The X STOP implant is a titanium alloy device that is placed between the spinous processes to reduce the canal and foraminal narrowing that occurs in extension. In a cohort of 75 patients with degenerative spondylolisthesis, 42 underwent surgical treatment in which the X STOP IPD device was placed and 33 control individuals were treated nonoperatively. Patients underwent serial follow-up evaluations. The Zurich Claudication Questionnaire (ZCQ), 36-Item Short Form Health Survey (SF-36), and radiographic assessment were used to determine outcomes. Two-year follow-up data were obtained in 70 of 75 patients. Statistically significant improvement in ZCQ and SF-36 scores was seen in X STOP device-treated patients but not in the nonoperative control patients at all postoperative intervals. Overall clinical success occurred in 63.4% of X STOP device-treated patients and only 12.9% of controls. Spondylolisthesis and kyphosis were unaltered. Conclusions. The X STOP device was more effective than nonoperative treatment in the management of NIC secondary to degenerative lumbar spondylolisthesis.

Treatment of neurogenic claudication by interspinous decompression: application of the X STOP device in patients with lumbar degenerative spondylolisthesis

Interspinous process decompression (IPD) theoretically relieves narrowing of the spinal canal and neural foramen in extension and thus reduces the symptoms of neurogenic intermittent claudication (NIC). The purpose of this study was to compare the efficacy of IPD with nonoperative treatment in patients with NIC secondary to degenerative spondylolisthesis. The authors conducted a randomized controlled study in patients with NIC; they compared the results obtained in patients treated with the X STOP IPD device with those acquired in patients treated nonoperatively. The X STOP implant is a titanium alloy device that is placed between the spinous processes to reduce the canal and foraminal narrowing that occurs in extension. In a cohort of 75 patients with degenerative spondylolisthesis, 42 underwent surgical treatment in which the X STOP IPD device was placed and 33 control individuals were treated nonoperatively. Patients underwent serial follow-up evaluations. The Zurich Claudication Questionnaire (ZCQ), 36-Item Short Form Health Survey (SF-36), and radiographic assessment were used to determine outcomes. Two-year follow-up data were obtained in 70 of 75 patients. Statistically significant improvement in ZCQ and SF-36 scores was seen in X STOP device-treated patients but not in the nonoperative control patients at all postoperative intervals. Overall clinical success occurred in 63.4% of X STOP device-treated patients and only 12.9% of controls. Spondylolisthesis and kyphosis were unaltered. The X STOP device was more effective than nonoperative treatment in the management of NIC secondary to degenerative lumbar spondylolisthesis.

9:26 Treatment of lumbar spinal stenosis with an interspinous spacer

Purpose of study: A newly developed spinal implant for the treatment of symptomatic lumbar spinal stenosis is being evaluated in a prospective randomized multicenter study. The implant is placed between the spinous processes of the affected level(s), and the intent is to position the stenotic segment in slight flexion, and by preventing extension, the symptoms of lumbar spinal stenosis will be relieved. The primary objective of this study is to evaluate the safety and efficacy of the implant in a clinical trial setting.Methods used: The surgical implantation of the implant is performed under local anesthesia and routinely requires 30 minutes to 1 hour of surgical time. There is negligible blood loss. The patients typically return home 3 hours after surgery. Two hundred nine patients with neurogenic claudication at the L3–L4 and/or L4–L5 levels have been enrolled in the randomized prospective study. One hundred fifteen of these patients have received the implant (X-Stop; St. Francis Medical Technologies, Concord, CA), and 94 have been treated conservatively including epidural injections. Before surgery, all patients completed an initial Zurich Claudication Questionnaire (ZCQ). The ZCQ is a self-administered survey developed to be a spinal stenosis specific outcome measure consisting of symptom severity, physical function and satisfaction scales [1]. A patient must improve in each of the three categories to be considered a success. In the current study, the ZCQ scores were available for comparison between the implant and conservative groups at 6-week, 6-month and 1-year time points. The two groups were compared statistically using Fisher's exact test (p<.05).of findings: To date, 209 patients have completed the 6-week ZCQ (115 implant and 94 conservative), 176 have completed the 6-month ZCQ (91 implant and 85 conservative) and 100 have completed the 1-year questionnaire (46 implant and 54 conservative). The overall success rates for the implant group are significantly greater than those of the conservative group at each time point (Table 1)Table 1Success rates of the implant and conservative groupsImplant successConservative successp Value6 weeks66/115 (57%)9/94 (10%)<.0016 months50/91 (55%)5/85 (6%)<.0011 year32/46 (70%)1/54 (2%)<.001. Moreover, at 1 year the success rates for the symptom severity, physical function and satisfaction categories were 86%, 83% and 88%, respectively, for the implant group, and 11%, 11% and 28% for the conservative group.Relationship between findings and existing knowledge: The results of this study demonstrate that the implant may be effective in treating pain in patients with lumbar spinal stenosis. This series of patients demonstrates the relative safety and efficacy of a newly developed spinal implant for the treatment of symptomatic lumbar spinal stenosis. In many ways this short-term preliminary follow-up compares favorably to traditional surgical treatment as well as nonsurgical treatment in selected cases. The surgical procedure is minimally invasive, inexpensive and safe. There were no intraoperative complications. Finally, the measurement instrument has been demonstrated to be responsive and sensitive enough to measure clinically significant improvements in mild to severe cases.Overall significance of findings: These findings indicate that the implant may be an effective means of treating painful and debilitating symptoms of lumbar spinal stenosis.Disclosures: Device or drug: X-Stop, Investigational Device Exemption (IDE). Status: investigational.Conflict of interest: Scott Yerby, stockholder; James Zucherman, stockholder; Ken Hsu, stockholder.