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

Low Back Pain Clinical Trial

Official title:

RCT Comparing i-FACTOR and Allograft in Spinal Fusion Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895555
• Other study ID #: 20120012
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2013
• Last updated: September 8, 2016
• Start date: March 2012
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: Sygehus Lillebaelt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Se above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 100 Years

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Spinal Stenosis

Intervention

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.
• Allograft
Approx 50 g of allograft bone in the fused site

Locations

Country	Name	City	State
Denmark	Middelfart Spine Surgery	Middelfart	Region of Southern Denmark
Denmark	Middelfart spine surgery research department	Middelfart

Sponsors (3)

Lead Sponsor	Collaborator
Sygehus Lillebaelt	CeraPedics, Inc, Ortotech

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry disability index	questionnaire	At 24 months	Yes
Secondary	Dallas pain questionnaire	questionnaire	At 24 months	Yes
Secondary	Walking distance	measuring distance	At 24 months	Yes
Secondary	EQ5D	questionnaire	At 24 months	Yes
Secondary	SF-36	questionnaire	At 24 months	Yes