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

NCT02895555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-04-19

No results posted yet for this study

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

Interventions

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.

PROCEDURE

Allograft

Approx 50 g of allograft bone in the fused site

Sponsors & Collaborators

  • Ortotech

    collaborator UNKNOWN

  • CeraPedics, Inc

    collaborator INDUSTRY

  • Spine Centre of Southern Denmark

    lead OTHER

Principal Investigators

  • Mikkel Andersen, MD · Department of spine surgery of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02895555 on ClinicalTrials.gov