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

NCT ID: NCT02895555

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2020-09-30

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.

Detailed Description

Se above

Conditions

Spinal Stenosis; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Allograft group, standard treatment

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

Group Type: ACTIVE_COMPARATOR

Allograft

Intervention Type: PROCEDURE

Approx 50 g of allograft bone in the fused site

i-FACTOR

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

Group Type: EXPERIMENTAL

i-FACTOR

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Allograft

Approx 50 g of allograft bone in the fused site

Intervention Type: PROCEDURE

Other Intervention Names

P15

Eligibility Criteria

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. -

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortotech

UNKNOWN

Sponsor Role: collaborator

CeraPedics, Inc

INDUSTRY

Sponsor Role: collaborator

Spine Centre of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Karen Højmark Hansen

Research coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikkel Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of spine surgery of Southern Denmark

Locations

Middelfart spine surgery research department

Middelfart, , Denmark

Countries

Denmark

Other Identifiers

20180146

Identifier Type: OTHER

Identifier Source: secondary_id

20120012

Identifier Type: -

Identifier Source: org_study_id