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NCT Number: NCT02895555

The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Fusion The IVANOS-study

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-operative 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 recommended.

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 difficult patient population.

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

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Key information

Conditions

Spinal Stenosis Back Pain Bone Diseases Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Middelfart spine surgery research department

Middelfart, 5500, Denmark

About this study

Se above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any disease demanding obligate thromboprophylaxis treatment, including mechanical valve, (DVT with cancer/thrombophilia, AMI, apoplexia cerebri, TCI, valve-operation)< 3 months, coronar metal stent < 6 weeks and coronar drug eluted/coated stent < 12 months.
  • Atrial fibrillation and one of the following: Mitral stenosis, valve prothesis and apoplexia cerebri/TCI.
  • Atrial fibrillation and two of the following: Heart insufficient, HT, DM, age > 75 years, EF < 35 %.
  • Known cancer in the axial skeleton.
  • Ongoing chemotherapy.
  • Fracture i the lower back within a year prior to inclusion.
  • Reduced distance of walking due to non-spinal related causes.
  • Candidate for more than two-level intervention.
  • Dementia assessed by the MMSE
  • ASA 3+4
  • Age below 60 years.
  • Missed 3 months of conservative treatment without success
  • The use of steroids and bisphosphonates.
  • Prior radiotherapy to the lower back.
  • Haematologic disease. -

Treatment and study plan

i-FACTOR

Procedure

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 allograft.

Other names: P15

Allograft

Procedure

Approx 50 g of allograft bone in the fused site

Primary outcomes

  1. Oswestry disability index

    Time frame: At 60 months

    questionnaire

Secondary outcomes

  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 60 months

    questionnaire

  4. SF-36

    Time frame: At 60 months

    questionnaire

  5. Fusion status yes/no

    Time frame: At 60 months

    Obtained by CT-scan

Sponsors and collaborators

Lead sponsor

Spine Centre of Southern Denmark

Other

Collaborators

  • CeraPedics, Inc
  • Ortotech

Registry information

Official study title

RCT Comparing i-FACTOR and Allograft in Spinal Fusion Surgery

Acronym: IVANOS

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2016
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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