Pedicle Screw Fixation in Osteoporotic Lumbar Spine

NCT04399421 | Unknown DMC

• 1 other identifier: BYSYDL2019006
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational single-center study. The osteoporotic patients requiring pedicle screw fixation for lumbar degenerative diseases are prospectively enrolled and followed up. This study mainly focuses on the most common osteoporosis-related surgical complications, which are pedicle screw loosening and the failure of lumbar fusion. The global and local bone mineral density(BMD) are evaluated with DXA, vertebral CT Hounsfield units(HU) before the surgery. The mechanical strength of the bone mass within the screw trajectory is also measured with a customized device during the surgery. We explored the effect of BMD on the pedicle screw loosening rate and fusion rate. In addition, the patients undergoing lumbar fixation with conventional pedicle screws without the use of bone cement are compared with those undergoing the fixation augmented with bone cement. The objective is to offer more detailed clinical evidence to guide the use of pedicle screw augmentation techniques in osteoporotic patients.

Conditions

Osteoporosis; Degenerative Lumbar Diseases

Keywords

Osteoporosis; Pedicle screw fixation; Degenerative lumbar diseases

Outcome Measures

Primary Outcomes (2)

• Pedicle screw loosening

  The presence of radiolucent zones of ≥1mm thick around any pedicle screw, broken screws, or obvious screw back-out and cut-out on x-ray or CT images

  12 months

• Lumbar fusion

  The presence of continuous fusion mass at any fusion segment in CT scans and no obvious intervertebral mobility at any fusion segment on lateral flexion-extension x-ray images.

  12 months

Secondary Outcomes (5)

• Pedicle screw loosening

  3 months; 6 months; 24 months

• Lumbar fusion

  3 months; 6 months; 24 months

• The Oswestry Disability Index（ODI）

  3 months; 12 months; 6 months; 24 months

• VAS score for low back pain

  3 months; 12 months; 6 months; 24 months

• VAS score for leg pain

  3 months; 12 months; 6 months; 24 months

Study Arms (2)

Conventional pedicle screw fixation

Patients undergoing conventional pedicle screw fixation without the use of bone cement.

Cement-augmented pedicle screw fixation

Patients undergoing pedicle screw fixation augmented with bone cement.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the orthopaedic department of the Peking University Third Hospital, the osteoporotic in-patients requiring lumbar pedicle screw fixation for lumbar degenerative diseases are invited to participate in the study.

You may qualify if:

• aged≥ 50 years old
• lumbar degenerative diseases requiring lumbar fusion with pedicle screw fixation, such as degenerative lumbar spinal stenosis, degenerative lumbar spondylolisthesis and etc.
• no response to nonoperative treatment of at least 3 months
• osteoporosis diagnosed by any method for bone mineral density evaluation, such as DXA, QCT, or vertebral Hounsfield units
• informed consent

You may not qualify if:

• no lumbar CT scans within 3 months before the surgery
• no dual energy x-ray absorptiometry within 6 months before the surgery
• history of lumbar fusion surgery
• cervical myelopathy, thoracic spinal stenosis, motor neuron disease, tuberculosis of spine, spinal tumor

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (11)

• Pannell WC, Savin DD, Scott TP, Wang JC, Daubs MD. Trends in the surgical treatment of lumbar spine disease in the United States. Spine J. 2015 Aug 1;15(8):1719-27. doi: 10.1016/j.spinee.2013.10.014. Epub 2013 Oct 31.

  PMID: 24184652 BACKGROUND

• Amirouche F, Solitro GF, Magnan BP. Stability and Spine Pedicle Screws Fixation Strength-A Comparative Study of Bone Density and Insertion Angle. Spine Deform. 2016 Jul;4(4):261-267. doi: 10.1016/j.jspd.2015.12.008. Epub 2016 Jun 16.

  PMID: 27927514 BACKGROUND

• Okuyama K, Abe E, Suzuki T, Tamura Y, Chiba M, Sato K. Influence of bone mineral density on pedicle screw fixation: a study of pedicle screw fixation augmenting posterior lumbar interbody fusion in elderly patients. Spine J. 2001 Nov-Dec;1(6):402-7. doi: 10.1016/s1529-9430(01)00078-x.

  PMID: 14588296 BACKGROUND

• Bredow J, Boese CK, Werner CM, Siewe J, Lohrer L, Zarghooni K, Eysel P, Scheyerer MJ. Predictive validity of preoperative CT scans and the risk of pedicle screw loosening in spinal surgery. Arch Orthop Trauma Surg. 2016 Aug;136(8):1063-7. doi: 10.1007/s00402-016-2487-8. Epub 2016 Jun 16.

  PMID: 27312862 BACKGROUND

• Galbusera F, Volkheimer D, Reitmaier S, Berger-Roscher N, Kienle A, Wilke HJ. Pedicle screw loosening: a clinically relevant complication? Eur Spine J. 2015 May;24(5):1005-16. doi: 10.1007/s00586-015-3768-6. Epub 2015 Jan 24.

  PMID: 25616349 BACKGROUND

• Tokuhashi Y, Matsuzaki H, Oda H, Uei H. Clinical course and significance of the clear zone around the pedicle screws in the lumbar degenerative disease. Spine (Phila Pa 1976). 2008 Apr 15;33(8):903-8. doi: 10.1097/BRS.0b013e31816b1eff.

  PMID: 18404111 BACKGROUND

• Goldstein CL, Brodke DS, Choma TJ. Surgical Management of Spinal Conditions in the Elderly Osteoporotic Spine. Neurosurgery. 2015 Oct;77 Suppl 4:S98-107. doi: 10.1227/NEU.0000000000000948.

  PMID: 26378363 BACKGROUND

• Janssen I, Ryang YM, Gempt J, Bette S, Gerhardt J, Kirschke JS, Meyer B. Risk of cement leakage and pulmonary embolism by bone cement-augmented pedicle screw fixation of the thoracolumbar spine. Spine J. 2017 Jun;17(6):837-844. doi: 10.1016/j.spinee.2017.01.009. Epub 2017 Jan 17.

  PMID: 28108403 BACKGROUND

• Zou D, Muheremu A, Sun Z, Zhong W, Jiang S, Li W. Computed tomography Hounsfield unit-based prediction of pedicle screw loosening after surgery for degenerative lumbar spine disease. J Neurosurg Spine. 2020 Jan 3;32(5):716-721. doi: 10.3171/2019.11.SPINE19868. Print 2020 May 1.

  PMID: 31899883 BACKGROUND

• Zou D, Jiang S, Zhou S, Sun Z, Zhong W, Du G, Li W. Prevalence of Osteoporosis in Patients Undergoing Lumbar Fusion for Lumbar Degenerative Diseases: A Combination of DXA and Hounsfield Units. Spine (Phila Pa 1976). 2020 Apr 1;45(7):E406-E410. doi: 10.1097/BRS.0000000000003284.

  PMID: 31725127 BACKGROUND

• Zou D, Li W, Deng C, Du G, Xu N. The use of CT Hounsfield unit values to identify the undiagnosed spinal osteoporosis in patients with lumbar degenerative diseases. Eur Spine J. 2019 Aug;28(8):1758-1766. doi: 10.1007/s00586-018-5776-9. Epub 2018 Oct 10.

  PMID: 30306332 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Weishi Li, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: February 3, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The IPD will become available half a year after the publication of the results of the study.

Locations

CN (1)