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Trial record 8 of 39 for:    "Spinal Disease" | "Benzocaine"

Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication (Size)

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ClinicalTrials.gov Identifier: NCT03480893
Recruitment Status : Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
Park MC
Maasstad Hospital
Information provided by (Responsible Party):
Pravesh S. Gadjradj, Erasmus Medical Center

Brief Summary:

Rationale: Minimally invasive techniques have gained popularity to decompress lumbar spinal stenosis in the elderly. However, high quality evidence based on randomised controlled trials are not available.

Objective: To investigate whether small size interarcuair decompression is more effective than conventional laminectomy in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. Study design: Double-blinded multi-centre randomised controlled trial Study population: In total 236 patients are to be included. The inclusion criteria are: subjects > 40 years of age with at least 12 weeks of complaints of intermittent neurogenic claudication based on MRI confirmed of LSS, with sufficient knowledge of the Dutch language.

Intervention: Small size interarcuair decompression versus conventional laminectomy.

Main study parameters/endpoints: Primary outcome is the Modified Roland Morris Questionnaire. Secondary outcomes are leg pain, back pain and a 6 minute walk test amongst others.

Nature and extent of the burden and risks associated with participation: based on available literature , it is believed that the risks associated with small size interarcuair decompression are no greater than that associated with a laminectomy, although these will be examined.


Condition or disease Intervention/treatment Phase
Stenoses, Spinal Procedure: small size interarcuair decompression Procedure: Laminectomy Not Applicable

Detailed Description:

Intermittent neurogenic claudication (INC) caused by a lumbar spinal canal stenosis (LSS) is the most frequent reason for spinal surgery in the elderly. Multiple, less invasive surgical techniques are applied without sufficient evidence for benefits for patients or society.

The classic symptoms of INC are leg pain, which can be exacerbated with prolonged walking and standing and/or lumbar extension, and is associated with back pain. Severe stenosis is common in the elderly spine with 30.4% of the population having severe stenosis. However, only 17.5% have complaints of INC.

Conservative treatment, such as physical therapy or pain medication, may give some relief of symptoms. However, surgical treatment is considered to be the gold standard for patients with INC caused by LSS. The first technique ever described to widen the lumbar spinal canal is the wide bony decompression (laminectomy), which is still a widely used technique. However, since INC is often accompanied by back pain, and this to post-operative back pain, it is hypothesized that a wide decompression is a ground for potential instability. Hence, less invasive techniques, such as interarcuair decompression, were developed and implemented.

Recent studies claim that a limited bony decompression is the new 'golden standard' therapy for patients with INC. Limited bony decompression is believed to give less muscle damage and thus a faster postoperative recovery. Furthermore, wide bony decompression (such as a laminectomy) is believed to result in lumbar instability and iatrogenic scoliosis. Performing a procedure with potential more complications in a - generally - elderly population could at least be described as doubtful. The assumption is often made that after a wide decompression recurrence of the complaints must be scarce. However, a (cost-) effectiveness study, which evaluates the effectiveness of small bony decompression compared to a 'classical' extensive bony decompression, has not been performed yet. The opinions on this matter are diverse. A laminectomy involves the removal of more bone and structures at the back of the spine which may result in longer hospitalization and loss of productivity, but it could also lead to spinal instability on the long term. However, the risk of an insufficient decompression may be higher, potentially leading to more reoperations.

By the means of this double-blinded, multi-center randomized controlled trial the investigators will determine the (cost-) effectiveness of a limited bony decompression compared to a wide bony decompression in patients with INC.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication (Size-study): a Multi-center, Double-blinded Randomized Controlled Trial
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2024

Arm Intervention/treatment
Experimental: Small size interarcuair decompression
Patients will undergo small size interarcuair decompression
Procedure: small size interarcuair decompression
A median lumbar incision is made and the paravertebral muscles are dissected subperiosteally and retracted unilaterally or bilaterally. Decompression will be applied via decompression of the ligamentum flavum. The lateral recess will be opened bilaterally and a medial facetectomy will be performed in order maintain stability of the segments. Posterior ligaments will be spared. The wound will be closed in layers with or without a suction drain. Patients will be operated with a loupe magnification or microscope depending on the surgeon's preference.

Active Comparator: Laminectomy
Patients will undergo laminectomy
Procedure: Laminectomy
A median lumbar incision is made over the spinous processes, the laminae of the affected level(s) are exposed subperiosteally, and the supraspinous ligament will be incised. The spinous process is removed. The supra and interspinous ligament of the affected level is removed by drill or Kerrison punches. The lamen is removed of the affect level, leaving the facet joint intact. The lateral recess will be opened bilaterally and medial facetectomy will be performed in order to maintain stability of the segments. When a single level stenosis is present (e.g. L4-L5) both laminae L4 and L5 will be removed. The wound will be closed in layers with or without a suction drain. Patients will be operated with loupe magnification or microscope depending surgeon's preference.




Primary Outcome Measures :
  1. Change on the Modified Roland-Morris Disability Questionnaire [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery ]
    This is a 24-point Dutch questionnaire that is designed to assess the physical disability in patients, due to lower back pain.


Secondary Outcome Measures :
  1. Change on the Numeric Rating Scale for leg pain [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery ]
    The pain intensity in both legs (affected and non-affected) will be rated on a 11-point scale.

  2. Change on the Numeric Rating Scale for back pain [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery ]
    The pain intensity in the back will be rated on a 11-point scale.

  3. Changes on the timed-up and go test [ Time Frame: baseline, 6 months, 12 months, 24 months and 48 months after surgery ]
    This time will be measured in seconds

  4. Changes on the 6-minute walk test [ Time Frame: baseline, 6 months, 12 months, 24 months and 48 months after surgery ]
    The endurance and distance will be measured.

  5. Changes on Neurological examination [ Time Frame: baseline, 6 months, 12 months, 24 months and 48 months after surgery ]
    Motor changes of lower muscles will be measured.

  6. Changes on the Timed Chair-Stand-Test (TCST) [ Time Frame: baseline, 6 months, 12 months, 24 months and 48 months after surgery ]
    The time between standing and sitting on a chair will be measured.

  7. Changes on the Oswestry Disability Index [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery ]
    The ODI is one of the principal condition-specific outcome measures used in the management of spinal disorders.

  8. Changes on Functional lumbar x-rays [ Time Frame: baseline, 6 weeks ]
    A functional X-ray will be obtained from all patients X-ray will be made from AP and lateral position to assess spondylolisthesis. Degenerative spondylilolisthesis is defined as a vertebral slip of at least 3 mm.

  9. Perceived recovery [ Time Frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery ]
    o measure the perceived recovery a seven-point Likert scale will be used. The score on this scale vary from 'completely recovered' to 'worse than ever'.

  10. Patient satisfaction [ Time Frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery ]
    To measure patient satisfaction a seven-point Likert scale will be used. The score on this scale vary from 'completely satisfied with current symptoms' to 'completely dissatisfied with current symptoms'.

  11. Changes on the SF-36 [ Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery ]
    The SF-36 will be used as a generic quality-of-life questionnaire. The SF-36 questionnaire has been validated and found reliable for low back pain.

  12. Complications [ Time Frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery ]
    A systematic assessment of complications (including wound infection, deep venous thrombosis, urine tract infection, hematoma, and progressive neurological deficit) will be recorded out by the surgeon and research nurse, and these data are to be extracted from the patient chart. Moreover, surgeons will be asked for perioperative complications

  13. Changes on the EuroQoL (EQ-5D) [ Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery ]
    The EuroQoL (EQ-5D) will be used for the cost utility analysis. The tool measures five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each dimension consists of one item, while five levels are distinguished (no, slight, moderate, severe problems, unable to do)

  14. Costs of treatment measured using cost questionnaires filled out by the patients [ Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery ]
    Cost questionnaires will be completed at the prescribed measurements. Hospitalisation for surgery will be registered using the case record forms. Other health care utilization (including physiotherapy, visits to GP and specialists, nursing care and medication), patient costs, and absenteeism from work will be measured using cost questionnaires filled out by the patients.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 12 weeks of complaints of INC
  • Magnetic resonance imaging showing LSS
  • Age >40 years of age
  • Sufficient knowledge of the Dutch language
  • Signed informed consent

Exclusion Criteria:

  • History of lumbar spine surgery
  • >2 lumbar levels operation or needed discectomy
  • Degenerative spondylolisthesis > grade 1 (on a scale of 1 to 4), scoliosis or disc herniation
  • ASA-classification >3
  • Serious psychopathology
  • Pregnancy
  • Active malignancy
  • Plans to move abroad during study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480893


Contacts
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Contact: Pravesh Gadjradj 003125689813 p.gadjradj@erasmusmc.nl

Locations
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Netherlands
Erasmus MC Not yet recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Contact: Pravesh Gadjradj       p.gadjradj@erasmusmc.nl   
Contact: Biswadjiet Harhangi         
Principal Investigator: Jamie Arjun Sharma         
Sponsors and Collaborators
Erasmus Medical Center
Park MC
Maasstad Hospital
Investigators
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Principal Investigator: Biswadjiet Harhangi Erasmus MC

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Responsible Party: Pravesh S. Gadjradj, PhD-candidate, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03480893     History of Changes
Other Study ID Numbers: MRace 108226
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pravesh S. Gadjradj, Erasmus Medical Center:
laminectomy
laminotomy
lumbar canal stenosis
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases