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

NCT02895555 | Completed DMC

• 2 other identifiers: 2012001220180146
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Spinal Stenosis; Low Back Pain

Keywords

Oswestry disability index (ODI)

Outcome Measures

Primary Outcomes (1)

• Oswestry disability index

  questionnaire

  At 60 months

Secondary Outcomes (5)

• Dallas pain questionnaire

  At 24 months

• Walking distance

  At 24 months

• EQ5D

  At 60 months

• SF-36

  At 60 months

• Fusion status yes/no

  At 60 months

Study Arms (2)

Allograft group, standard treatment

ACTIVE COMPARATOR

Control group, standard treatment. Approx 50 g pr level fused.

Procedure: Allograft

i-FACTOR

EXPERIMENTAL

i-FACTOR putty in the operation site. Fda approved. Approx 5 ml pr level fused.

Procedure: i-FACTOR

Interventions

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.

Also known as: P15

i-FACTOR

Allograft PROCEDURE

Approx 50 g of allograft bone in the fused site

Allograft group, standard treatment

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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. -

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead
• Ortotech: collaborator
• CeraPedics, Inc: collaborator

Study Sites (1)

Middelfart spine surgery research department

Middelfart, 5500, Denmark

Location

MeSH Terms

Conditions

Spinal Stenosis; Low Back Pain

Interventions

Fibrinogen; Cyclin-Dependent Kinase Inhibitor p15; Transplantation, Homologous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors; Cyclin-Dependent Kinase Inhibitor Proteins; Intracellular Signaling Peptides and Proteins; Peptides; Cell Cycle Proteins; Tumor Suppressor Proteins; Neoplasm Proteins; Transplantation; Surgical Procedures, Operative

Study Officials

• Mikkel Andersen, MD

  Department of spine surgery of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research coordinator

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: September 9, 2016
• Study Start: March 1, 2012
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 19, 2024

Record last verified: 2018-11

Locations

DK (1)