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

RCT Comparing i-FACTOR and Allograft in Spinal Fusion Surgery

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Spinal Stenosis
• Intervention / Treatment: Procedure: Allograft; Procedure: i-FACTOR

Detailed Description

Se above

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Middelfart, Denmark, 5500
    • Middelfart spine surgery research department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. A score of 6 and more on Konno´s "History of Examination Characteristic".
3. Signed informed content.

Exclusion Criteria:

1. 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.
2. Atrial fibrillation and one of the following: Mitral stenosis, valve prothesis 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 success
13. The use of steroids and bisphosphonates.
14. Prior radiotherapy to the lower back.
15. Haematologic disease. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Allograft group, standard treatment; Control group, standard treatment. Approx 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. Approx 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 allograft.; Other Names: P15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry disability index	questionnaire	At 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dallas pain questionnaire	questionnaire	At 24 months
Walking distance	measuring distance	At 24 months
EQ5D	questionnaire	At 60 months
SF-36	questionnaire	At 60 months
Fusion status yes/no	Obtained by CT-scan	At 60 months

Collaborators and Investigators

• Sponsor: Spine Centre of Southern Denmark
• Collaborators: CeraPedics, Inc; Ortotech
• Investigators: Principal Investigator: Mikkel Andersen, MD, Department of spine surgery of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimated): September 9, 2016

Study Record Updates

• Last Update Posted (Estimated): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Oswestry disability index (ODI)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Spinal Stenosis
• Other Study ID Numbers: 20120012; 20180146 (Ethics comitee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED