SpondylolisthesisNCT05565456
Intercorporal Bone Graft Measurement Study
An observational study of Spondylolisthesis and Spinal Fusion, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Spondylolisthesis, Spinal Fusion
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Dec 2022to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- receiving revision spine surgery
- not wanting to provide informed consent
- pregnant or expecting to be pregnant within in the next two years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Hounsfield Unit Measurements of Intercorporal Bone Grafts Remodelling Towards Spinal Fusion
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.
Read the detailed description
Instrumented lumbar spinal fusion is a surgical procedure that is widely being used to treat various spinal diseases such as deformities, spondylolisthesis, spondylolysis, spinal instability, and degenerative disc disease. Lumbar fusion is an effective treatment to stabilize the degenerative segments and promote bony fusion and is often combined with subsequent decompression of neural structures or correction of deformities. To date, various surgical fusion techniques are used, but consensus regarding a superior technique is lacking. Also, the location where a surgeon wants to achieve bony fusion varies. Interbody fusion is performed to fuse the upper endplate of one vertebra and the lower endplate of the adjacent vertebra. An intervertebral cage is often used to retain intervertebral height and stability. After insertion of the cage, autologous decompressive bone is impacted behind the cage. Over time, this non-vital bone graft is expected to remodel towards new vital bone and subsequently to create a sustainable fusion between two adjacent lumbar vertebral bodies. However, in case of resorption of the bone graft or adequate bone remodeling, solid bridging of bone may fail to develop and this may result in a pseudarthrosis or non-union. This clinically important complication occurs in 5% to 35% of patients treated with spinal fusion and can lead to pain and a decrease in functional status. Also, subsequent revision surgery for symptomatic pseudarthrosis occurs in up to 24% of patients after fusion surgery.
The gold standard to assess interbody fusion is surgical exploration, but due to unpractical and ethical considerations, monitoring fusion status is mainly limited to radiographic image evaluation. CT-scanning is the most established radiographic method option for this, but when a patient improves clinically, conventional radiographs are used more commonly. An orthopaedic surgeon can use several existing scoring criteria to judge the degree of solid bony bridging based on this radiographic imaging. However, research has shown that the inter-observer agreement and diagnostic accuracy of these scoring criteria is relatively low. Correct diagnosis of lumbar fusion on CT has been reported to be as low as 67-72% and at the cervical level non-unions are missed in 20% of the cases. The problem is that, to date, there is no quantitative and objective tool available to quantify the bone remodeling process and to precisely judge whether vertebrae have fused or not. In fact, there is an overall dearth of knowledge about the biological process of ongoing spinal fusion and its association with the development of back and/or leg pain.
In vivo bone remodeling can be monitored by using repeated Bone Mineral Density (BMD) measurements. BMD values are traditionally generated using two-dimensional dual-energy X-ray absorptiometry (DEXA) scans which are hindered by overprojection from the iliac crest and metal artefacts. A more suitable proxy for these measurements is the use of Hounsfield Units (HU). HU can be measured on CT-images and highly correlate with BMD. HU have already been used to determine vertebral bone quality after spine surgery and have several clinical applications, including the ability to predict the stability of orthopaedic implants and to assist in surgical decision-making. However, none of these studies have succeeded in improving diagnostic accuracy in establishing spinal fusion.
Quantifying the biological bone remodeling process in the bone graft over time can help to evaluate bone growth or bone resorption. Knowledge of changes in bone mineral density from the bone graft could be very useful supplementary information when doubts about fusion status exist. To date, only two feasibility studies with relatively small sample sizes have reported on the value of HU measurements to evaluate bone graft remodeling after lumbar interbody fusion surgery. In one previous cross-sectional study from Spruit et al., published almost 18 years ago, HU measurements were only performed once in the first year after spinal fusion surgery. As such, no information with regards to the evolution of bone graft HU over time were obtained.
Recently the feasibility of HU measurements after lumbar spondylodesis (Reijmer et al, submitted) was explored. The HU measurement procedure that was developed during this study had excellent intraobserver reliability. The individual HU trajectories also suggested bone remodeling was not yet completed between one and two years after surgery. However, limitations of the study were a small sample size, the absence of postoperative CT-images made shortly after surgery and the absence of information about the participants' postoperative back and leg pain. This limited insight into the progression of pain and the process of bone graft remodeling in the first year after surgery. This study will build upon the results of the former study in an effort to further the state of the art in this important field of orthopaedics.
- Conditions
- Spondylolisthesis, Spinal Fusion
- Keywords
- Bone Density, Bone Remodelling, Tomography, X-Ray Computed
- Medical subject headings
- Spondylolisthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 using the 5-point intercorporal fusion criteria by Brantigan et al.
Measured: 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 using a (100mm) Visual Analogue Scale (VAS). A higher score indicates more pain.
Measured: 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 using the Dutch version of the Oswestry Low Back Pain Disability Questionnaire (ODI). Scores range from 0-50. A higher score (percentage) indicates a higher degree of functional disability.
Measured: 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 using the Dutch version of the 36-item Research and Development (RAND-36) Health Survey. Scores range depending on the calculation method used. Higher scores indicate better self-reported quality of life.
Measured: The self-reported quality of life will be assessed at baseline, at 6 months, at one year and at two years post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start2 Dec 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for SpondylolisthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Job LC van Susante, Dr. PhD., Principal investigator, Rijnstate ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565456
- Sponsor's protocol ID
- NL81678.091.22
- Other IDs
- 2022-13716
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2022
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mobbs RJ, Phan K, Malham G, Seex K, Rao PJ. Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIF, MI-TLIF, OLIF/ATP, LLIF and ALIF. J Spine Surg. 2015 Dec;1(1):2-18. doi: 10.3978/j.issn.2414-469X.2015.10.05.
PubMed 27683674Cole CD, McCall TD, Schmidt MH, Dailey AT. Comparison of low back fusion techniques: transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody fusion (PLIF) approaches. Curr Rev Musculoskelet Med. 2009 Jun;2(2):118-26. doi: 10.1007/s12178-009-9053-8. Epub 2009 Apr 29.
PubMed 19468868Chun DS, Baker KC, Hsu WK. Lumbar pseudarthrosis: a review of current diagnosis and treatment. Neurosurg Focus. 2015 Oct;39(4):E10. doi: 10.3171/2015.7.FOCUS15292.
PubMed 26424334Martin BI, Mirza SK, Comstock BA, Gray DT, Kreuter W, Deyo RA. Reoperation rates following lumbar spine surgery and the influence of spinal fusion procedures. Spine (Phila Pa 1976). 2007 Feb 1;32(3):382-7. doi: 10.1097/01.brs.0000254104.55716.46.
PubMed 17268274Fogel GR, Toohey JS, Neidre A, Brantigan JW. Fusion assessment of posterior lumbar interbody fusion using radiolucent cages: X-ray films and helical computed tomography scans compared with surgical exploration of fusion. Spine J. 2008 Jul-Aug;8(4):570-7. doi: 10.1016/j.spinee.2007.03.013. Epub 2007 May 29.
PubMed 17544854Kim KS, Yang TK, Lee JC. Radiological changes in the bone fusion site after posterior lumbar interbody fusion using carbon cages impacted with laminar bone chips: follow-up study over more than 4 years. Spine (Phila Pa 1976). 2005 Mar 15;30(6):655-60. doi: 10.1097/01.brs.0000155421.07796.7f.
PubMed 15770181Sakeb N, Ahsan K. Comparison of the early results of transforaminal lumbar interbody fusion and posterior lumbar interbody fusion in symptomatic lumbar instability. Indian J Orthop. 2013 May;47(3):255-63. doi: 10.4103/0019-5413.111484.
PubMed 23798756Williams AL, Gornet MF, Burkus JK. CT evaluation of lumbar interbody fusion: current concepts. AJNR Am J Neuroradiol. 2005 Sep;26(8):2057-66. No abstract available.
PubMed 16155160Brantigan JW, Steffee AD. A carbon fiber implant to aid interbody lumbar fusion. Two-year clinical results in the first 26 patients. Spine (Phila Pa 1976). 1993 Oct 15;18(14):2106-7. doi: 10.1097/00007632-199310001-00030.
PubMed 8272967Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis or anterior column defects? Spine (Phila Pa 1976). 1995 Jun 15;20(12):1410-8.
PubMed 7676341Christensen FB, Laursen M, Gelineck J, Eiskjaer SP, Thomsen K, Bunger CE. Interobserver and intraobserver agreement of radiograph interpretation with and without pedicle screw implants: the need for a detailed classification system in posterolateral spinal fusion. Spine (Phila Pa 1976). 2001 Mar 1;26(5):538-43; discussion 543-4. doi: 10.1097/00007632-200103010-00018.
PubMed 11242382Soriano Sanchez JA, Soriano Solis S, Soto Garcia ME, Soriano Solis HA, Torres BYA, Romero Rangel JAI. Radiological diagnostic accuracy study comparing Lenke, Bridwell, BSF, and CT-HU fusion grading scales for minimally invasive lumbar interbody fusion spine surgery and its correlation to clinical outcome. Medicine (Baltimore). 2020 May 22;99(21):e19979. doi: 10.1097/MD.0000000000019979.
PubMed 32481262Brodsky AE, Kovalsky ES, Khalil MA. Correlation of radiologic assessment of lumbar spine fusions with surgical exploration. Spine (Phila Pa 1976). 1991 Jun;16(6 Suppl):S261-5. doi: 10.1097/00007632-199106001-00017.
PubMed 1862422Carreon LY, Glassman SD, Schwender JD, Subach BR, Gornet MF, Ohno S. Reliability and accuracy of fine-cut computed tomography scans to determine the status of anterior interbody fusions with metallic cages. Spine J. 2008 Nov-Dec;8(6):998-1002. doi: 10.1016/j.spinee.2007.12.004. Epub 2008 Feb 14.
PubMed 18280214van Bilsen MWT, Ullrich C, Ferraris L, Hempfing A, Hitzl W, Mayer M, Koller H. Diagnostic accuracy of CT scan-based criteria compared with surgical exploration for the analysis of cervical fusion and nonunion. J Neurosurg Spine. 2020 Mar 6;33(1):51-57. doi: 10.3171/2019.12.SPINE191011. Print 2020 Jul 1.
PubMed 32114527
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Hounsfield Unit Measurements of Intercorporal Bone Grafts Remodelling Towards Spinal Fusion
- ClinicalTrials.gov ID
- NCT05565456
- Acronym / sponsor ID
- NL81678.091.22
- Conditions
- Spondylolisthesis, Spinal Fusion
- Keywords
- Bone Density, Bone Remodelling, Tomography, X-Ray Computed
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Instrumented lumbar spinal fusion is a surgical procedure that is widely being used to treat various spinal diseases such as deformities, spondylolisthesis, spondylolysis, spinal instability, and degenerative disc disease. Lumbar fusion is an effective treatment to stabilize the degenerative segments and promote bony fusion and is often combined with subsequent decompression of neural structures or correction of deformities. To date, various surgical fusion techniques are used, but consensus regarding a superior technique is lacking. Also, the location where a surgeon wants to achieve bony fusion varies. Interbody fusion is performed to fuse the upper endplate of one vertebra and the lower endplate of the adjacent vertebra. An intervertebral cage is often used to retain intervertebral height and stability. After insertion of the cage, autologous decompressive bone is impacted behind the cage. Over time, this non-vital bone graft is expected to remodel towards new vital bone and subsequently to create a sustainable fusion between two adjacent lumbar vertebral bodies. However, in case of resorption of the bone graft or adequate bone remodeling, solid bridging of bone may fail to develop and this may result in a pseudarthrosis or non-union. This clinically important complication occurs in 5% to 35% of patients treated with spinal fusion and can lead to pain and a decrease in functional status. Also, subsequent revision surgery for symptomatic pseudarthrosis occurs in up to 24% of patients after fusion surgery.
The gold standard to assess interbody fusion is surgical exploration, but due to unpractical and ethical considerations, monitoring fusion status is mainly limited to radiographic image evaluation. CT-scanning is the most established radiographic method option for this, but when a patient improves clinically, conventional radiographs are used more commonly. An orthopaedic surgeon can use several existing scoring criteria to judge the degree of solid bony bridging based on this radiographic imaging. However, research has shown that the inter-observer agreement and diagnostic accuracy of these scoring criteria is relatively low. Correct diagnosis of lumbar fusion on CT has been reported to be as low as 67-72% and at the cervical level non-unions are missed in 20% of the cases. The problem is that, to date, there is no quantitative and objective tool available to quantify the bone remodeling process and to precisely judge whether vertebrae have fused or not. In fact, there is an overall dearth of knowledge about the biological process of ongoing spinal fusion and its association with the development of back and/or leg pain.
In vivo bone remodeling can be monitored by using repeated Bone Mineral Density (BMD) measurements. BMD values are traditionally generated using two-dimensional dual-energy X-ray absorptiometry (DEXA) scans which are hindered by overprojection from the iliac crest and metal artefacts. A more suitable proxy for these measurements is the use of Hounsfield Units (HU). HU can be measured on CT-images and highly correlate with BMD. HU have already been used to determine vertebral bone quality after spine surgery and have several clinical applications, including the ability to predict the stability of orthopaedic implants and to assist in surgical decision-making. However, none of these studies have succeeded in improving diagnostic accuracy in establishing spinal fusion.
Quantifying the biological bone remodeling process in the bone graft over time can help to evaluate bone growth or bone resorption. Knowledge of changes in bone mineral density from the bone graft could be very useful supplementary information when doubts about fusion status exist. To date, only two feasibility studies with relatively small sample sizes have reported on the value of HU measurements to evaluate bone graft remodeling after lumbar interbody fusion surgery. In one previous cross-sectional study from Spruit et al., published almost 18 years ago, HU measurements were only performed once in the first year after spinal fusion surgery. As such, no information with regards to the evolution of bone graft HU over time were obtained.
Recently the feasibility of HU measurements after lumbar spondylodesis (Reijmer et al, submitted) was explored. The HU measurement procedure that was developed during this study had excellent intraobserver reliability. The individual HU trajectories also suggested bone remodeling was not yet completed between one and two years after surgery. However, limitations of the study were a small sample size, the absence of postoperative CT-images made shortly after surgery and the absence of information about the participants' postoperative back and leg pain. This limited insight into the progression of pain and the process of bone graft remodeling in the first year after surgery. This study will build upon the results of the former study in an effort to further the state of the art in this important field of orthopaedics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- receiving revision spine surgery
- not wanting to provide informed consent
- pregnant or expecting to be pregnant within in the next two years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hounsfield Units (HU)
Time frame: The HU will be assessed in the first week after surgery, at 6 months, at one year and at two years post-surgery.
The participants' individual and group (mean, SD) HU values of their intercorporal bone graft(s) will be calculated from their (four) CT-scans.
4 secondary outcomes
Intercorporal fusion
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The self-reported quality of life will be assessed at baseline, at 6 months, at one year and at two years post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 27683674Mobbs RJ, Phan K, Malham G, Seex K, Rao PJ. Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIF, MI-TLIF, OLIF/ATP, LLIF and ALIF. J Spine Surg. 2015 Dec;1(1):2-18. doi: 10.3978/j.issn.2414-469X.2015.10.05.
- Background: PubMed 19468868Cole CD, McCall TD, Schmidt MH, Dailey AT. Comparison of low back fusion techniques: transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody fusion (PLIF) approaches. Curr Rev Musculoskelet Med. 2009 Jun;2(2):118-26. doi: 10.1007/s12178-009-9053-8. Epub 2009 Apr 29.
- Background: PubMed 26424334Chun DS, Baker KC, Hsu WK. Lumbar pseudarthrosis: a review of current diagnosis and treatment. Neurosurg Focus. 2015 Oct;39(4):E10. doi: 10.3171/2015.7.FOCUS15292.
- Background: PubMed 17268274Martin BI, Mirza SK, Comstock BA, Gray DT, Kreuter W, Deyo RA. Reoperation rates following lumbar spine surgery and the influence of spinal fusion procedures. Spine (Phila Pa 1976). 2007 Feb 1;32(3):382-7. doi: 10.1097/01.brs.0000254104.55716.46.
- Background: PubMed 17544854Fogel GR, Toohey JS, Neidre A, Brantigan JW. Fusion assessment of posterior lumbar interbody fusion using radiolucent cages: X-ray films and helical computed tomography scans compared with surgical exploration of fusion. Spine J. 2008 Jul-Aug;8(4):570-7. doi: 10.1016/j.spinee.2007.03.013. Epub 2007 May 29.
- Background: PubMed 15770181Kim KS, Yang TK, Lee JC. Radiological changes in the bone fusion site after posterior lumbar interbody fusion using carbon cages impacted with laminar bone chips: follow-up study over more than 4 years. Spine (Phila Pa 1976). 2005 Mar 15;30(6):655-60. doi: 10.1097/01.brs.0000155421.07796.7f.
- Background: PubMed 23798756Sakeb N, Ahsan K. Comparison of the early results of transforaminal lumbar interbody fusion and posterior lumbar interbody fusion in symptomatic lumbar instability. Indian J Orthop. 2013 May;47(3):255-63. doi: 10.4103/0019-5413.111484.
- Background: PubMed 16155160Williams AL, Gornet MF, Burkus JK. CT evaluation of lumbar interbody fusion: current concepts. AJNR Am J Neuroradiol. 2005 Sep;26(8):2057-66. No abstract available.
- Background: PubMed 8272967Brantigan JW, Steffee AD. A carbon fiber implant to aid interbody lumbar fusion. Two-year clinical results in the first 26 patients. Spine (Phila Pa 1976). 1993 Oct 15;18(14):2106-7. doi: 10.1097/00007632-199310001-00030.
- Background: PubMed 7676341Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis or anterior column defects? Spine (Phila Pa 1976). 1995 Jun 15;20(12):1410-8.
- Background: PubMed 11242382Christensen FB, Laursen M, Gelineck J, Eiskjaer SP, Thomsen K, Bunger CE. Interobserver and intraobserver agreement of radiograph interpretation with and without pedicle screw implants: the need for a detailed classification system in posterolateral spinal fusion. Spine (Phila Pa 1976). 2001 Mar 1;26(5):538-43; discussion 543-4. doi: 10.1097/00007632-200103010-00018.
- Background: PubMed 32481262Soriano Sanchez JA, Soriano Solis S, Soto Garcia ME, Soriano Solis HA, Torres BYA, Romero Rangel JAI. Radiological diagnostic accuracy study comparing Lenke, Bridwell, BSF, and CT-HU fusion grading scales for minimally invasive lumbar interbody fusion spine surgery and its correlation to clinical outcome. Medicine (Baltimore). 2020 May 22;99(21):e19979. doi: 10.1097/MD.0000000000019979.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Job LC van Susante, Dr. PhD. principal investigator
Rijnstate ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylolisthesis and Spinal Fusion, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hounsfield Units (HU) (time frame: The HU will be assessed in the first week after surgery, at 6 months, at one year and at two years post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565456, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.