Evaluation of Fusion After ALIF With an Osteoinductive Material or With Homologus Bone

Fusion of Spine, Lumbar Region Clinical Trial

Official title:

Evaluation of Fusion After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: a First Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331159
• Other study ID #: NanoBone - ALIF
• Status: Completed
• Phase: N/A
• First received: October 29, 2017
• Last updated: October 31, 2017
• Start date: July 1, 2012
• Est. completion date: October 31, 2015

Study information

• Verified date: October 2017
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and clinical outcomes at 12 months follow-up compared with instrumented ALIF with homologous bone

Description:

This randomized clinical trial included two groups of 20 mature patients with mono- or multisegmental degenerative disease of the lumbar spine who were suitable to undergo mono- or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homologous bone (HB). Patients were followed 12 months postoperatively. The primary aim was to compare postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary aims were to compare postoperative radiographic outcomes and differences in pain and quality of life between these groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 31, 2015
• Est. primary completion date: October 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• chronic low back pain

• sensorimotor deficits

• radiculopathy and spinal claudication symptoms, all caused by degenerative changes in the lumbar spine, which were resistant to conservative pain therapy and / or physiotherapy

Exclusion Criteria:

• previous surgeries in the abdominal Region

• previous fusion surgery in the lumbar spine.

Related Conditions & MeSH terms

• Fusion of Spine, Lumbar Region

Intervention

Device:
• NanoBone
Cage was filled with nanocrystalline hydroxyapatite embedded in a silica gel matrix
• Homologous Bone
Cage was filled with homologous bone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI)	Postoperative disability as measured by the Oswestry Disability Index (ODI)	12 months after surgery
Secondary	Fusion rate	Postoperative radiographic Fusion rate	12 months after surgery