Intercorporal Bone Graft Measurement Study

NCT05565456 | Active Not Recruiting DMC

• 2 other identifiers: NL81678.091.222022-13716
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Instrumented lumbar fusion surgery is often accompanied by interbody fusion using an autologous bone graft that is supposed to expand and remodel to achieve a rigid and lasting bony construction between two vertebrae. However, there is a dearth of knowledge regarding the process of biological remodelling of intercorporal bone grafts. Also, a valid and reliable assessment of fusion status remains challenging because there is no objective tool available to quantify the bone remodelling process. CT-based Hounsfield Units correlate with Bone Mineral Density and can be used as a proxy to establish trajectories over time to assess changes in bone mineral density from the bone graft.

Conditions

Spondylolisthesis; Spinal Fusion

Keywords

Bone Density; Bone Remodelling; Tomography, X-Ray Computed

Outcome Measures

Primary Outcomes (1)

• Hounsfield Units (HU)

  The participants' individual and group (mean, SD) HU values of their intercorporal bone graft(s) will be calculated from their (four) CT-scans.

  The HU will be assessed in the first week after surgery, at 6 months, at one year and at two years post-surgery.

Secondary Outcomes (4)

• Intercorporal fusion

  Intercorporal fusion will be assessed in the first week after surgery, at 6 months, at one year and at two years post-surgery.

• Visual Analogue Scale (VAS) for back and leg pain.

  Back and leg pain will be assessed at baseline, at 6 months, at one year and at two years post-surgery.

• Oswestry Low Back Pain Disability Questionnaire (ODI), Dutch version.

  The degree of functional disability will be assessed at baseline, at 6 months, at one year and at two years post-surgery.

• 36-item Research and Development (RAND-36) Health Survey, Dutch version.

  The self-reported quality of life will be assessed at baseline, at 6 months, at one year and at two years post-surgery.

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thirty patients with a symptomatic spondylolisthesis (lytic/degenerative/iatrogenic) who have an indication for single level lumbar interbody fusion (PLIF/TLIF) will be recruited.

You may qualify if:

• non-responsiveness to non-operative treatment in the six months prior to study enrolment
• fusion indicated for only one segment in the L1 to S1/ilium region
• between the age of 45 and 80.

You may not qualify if:

• receiving revision spine surgery
• not wanting to provide informed consent
• pregnant or expecting to be pregnant within in the next two years.

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800 WC, Netherlands

Location

Related Publications (23)

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• Schreiber JJ, Anderson PA, Hsu WK. Use of computed tomography for assessing bone mineral density. Neurosurg Focus. 2014;37(1):E4. doi: 10.3171/2014.5.FOCUS1483.

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• Lee S, Chung CK, Oh SH, Park SB. Correlation between Bone Mineral Density Measured by Dual-Energy X-Ray Absorptiometry and Hounsfield Units Measured by Diagnostic CT in Lumbar Spine. J Korean Neurosurg Soc. 2013 Nov;54(5):384-9. doi: 10.3340/jkns.2013.54.5.384. Epub 2013 Nov 30.

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• Schreiber JJ, Anderson PA, Rosas HG, Buchholz AL, Au AG. Hounsfield units for assessing bone mineral density and strength: a tool for osteoporosis management. J Bone Joint Surg Am. 2011 Jun 1;93(11):1057-63. doi: 10.2106/JBJS.J.00160.

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• Spruit M, Meijers H, Obradov M, Anderson PG. CT density measurement of bone graft within an intervertebral lumbar cage: increase of hounsfield units as an indicator for increasing bone mineral content. J Spinal Disord Tech. 2004 Jun;17(3):232-5. doi: 10.1097/00024720-200406000-00011.

  PMID: 15167340 BACKGROUND

• Reijmer JFH, de Jong LD, Kruyt MC, van Gorp MJ, Susante JLC. Repeated CT-based Hounsfield Unit Measurements as a Proxy Measure of Intercorporal Bone Graft Remodeling Towards Spinal Fusion; a Feasibility Study. [Submitted].

  BACKGROUND

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Job LC van Susante, Dr. PhD.

  Rijnstate ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 4, 2022
• Study Start: December 2, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

NL (1)