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The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumentated Posterolateral Fusionin The IVANOS-study

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ClinicalTrials.gov Identifier: NCT02895555
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : September 9, 2016
Sponsor:
Collaborators:
Ortotech
CeraPedics, Inc
Information provided by (Responsible Party):
Michael Kjaer Jacobsen, Sygehus Lillebaelt

Brief Summary:

The average life expectancy in Denmark is increasing resulting in an increasing part of the population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back, especially when standing and walking, known as neurogenic claudicatio(Goh KJ FAU - Khalifa et al.). LSS occurs in a combination of degenerative changes in the lower back, including hypertrophy of the ligamentum flavum, arthrosis of the facet joints and bulging of the disc.

Current treatment of LSS is varied ranging from non-operativ conservative treatment to operation.

Operative intervention shows very good results according to physical ability and pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.), but the most optimal treatment is still debated. Nevertheless, a decompression and, if needed, a spinal fusion is recommented.(Ausman).

The investigators want to se whether i-FACTOR improves clinical outcomes compared to using allograft in spinal fusion in the elderly, and thereby find an improved methods operating this diffycult patient population.

The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR or allograft i non-instrumentated spinal fusion surgery in patients with spinal stenosis due to degenerative listhesis.


Condition or disease Intervention/treatment Phase
Spinal Stenosis Low Back Pain Procedure: i-FACTOR Procedure: Allograft Phase 4

Detailed Description:
Se above

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RCT Comparing i-FACTOR and Allograft in Spinal Fusion Surgery
Study Start Date : March 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Active Comparator: Allograft group, standard treatment
Control group, standard treatment. Aprox 50 g pr level fused.
Procedure: Allograft
Approx 50 g of allograft bone in the fused site

Experimental: i-FACTOR
i-FACTOR putty in the operation site. Fda approved. Aprox 5 ml pr level fused.
Procedure: i-FACTOR
Between 5-10 CC i-FACTOR putty mixed with local harvested autograft pr level spondylodesis compared to 30 grams of allograft pr level mixed with local harvested aulograft.
Other Name: P15




Primary Outcome Measures :
  1. Oswestry disability index [ Time Frame: At 24 months ]
    questionnaire


Secondary Outcome Measures :
  1. Dallas pain questionnaire [ Time Frame: At 24 months ]
    questionnaire

  2. Walking distance [ Time Frame: At 24 months ]
    measuring distance

  3. EQ5D [ Time Frame: At 24 months ]
    questionnaire

  4. SF-36 [ Time Frame: At 24 months ]
    questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Spinal stenosis, listhesis grade 1-2 (>3 mm), facet joint arthrosis and flavum hypertrophya verified by a mr-scan and x-ray including maximally 2 levels ranging from L1-S1.
  2. A score of 6 and more on Konno´s "History of Examination Characteristic".
  3. Signed informed content.

Exclusion Criteria:

  1. Any disease demanding obligat thromboprophylaxis treatment, including mekanical valve, (DVT with cancer/thrombofilia, AMI, apoplexia cerebri, TCI, valve-operation)< 3 months, coronar metal stent < 6 weeks and coronar drug eluted/coated stent < 12 months.
  2. Atrial fibrillation and one of the following: Mitral stenosis, valveprothesis and apoplexia cerebri/TCI.
  3. Atrial fibrillation and two of the following: Heart insufficient, HT, DM, age > 75 years, EF < 35 %.
  4. Known cancer in the axial skeleton.
  5. Ongoing chemotherapy.
  6. Fracture i the lower back within a year prior to inclusion.
  7. Reduced distance of walking due to non-spinal related causes.
  8. Candidate for more than two-level intervention.
  9. Dementia assessed by the MMSE
  10. ASA 3+4
  11. Age below 60 years.
  12. Missed 3 months of conservative treatment without succes
  13. The use of steroids and bisphosfonates.
  14. Prior radiotherapy to the lower back.
  15. Haemologic disease. -

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): NCT02895555


Locations
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Denmark
Middelfart Spine Surgery
Middelfart, Region of Southern Denmark, Denmark, 5500
Middelfart spine surgery research department
Middelfart, Denmark, 5500
Sponsors and Collaborators
Sygehus Lillebaelt
Ortotech
CeraPedics, Inc
Investigators
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Principal Investigator: Michael k Jacobsen, MD Department of spine surgery of Southern Denmark

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Responsible Party: Michael Kjaer Jacobsen, Mr., Sygehus Lillebaelt
ClinicalTrials.gov Identifier: NCT02895555     History of Changes
Other Study ID Numbers: 20120012
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Michael Kjaer Jacobsen, Sygehus Lillebaelt:
ODI

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Spinal Stenosis
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases