A Retrospective Comparison Between CPS and HC Techniques for Osteoporotic Fractures in the Thoracic or Lumbar Spine

Study Overview
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Brief Summary
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Cement-augmented pedicle screws (CPS) and hybrid construct (HC) consisting of pedicle screws and additional hooks are common methods in osteoporotic fracture of the thoracic and lumbar spine. No study has compared the surgical results between CPS and HC techniques for treatment of the osteoporotic thoracic and lumbar spine fracture. The aim of the retrospective study was to compare surgical results using CPS or HC for osteoporotic fractures in the thoracic or lumbar spine. Patients who received surgical treatment with CPS or HC for osteoporotic fractures in the thoracic or lumbar spine.

Detailed Description
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Osteoporosis, the most common metabolic bone disease, leads to alteration of bone density that has been shown to compromise the strength of spinal instrumentation. With elderly populations growing, rates of spine surgery performed on osteoporotic patients have increased to treat a variety of conditions. Vertebral fracture is the most common osteoporotic fracture in the elderly, and surgical intervention is sometimes needed for patients who are diagnosed as nonunion, failure of vertebroplasty, and neurologic deficits. Therefore, spine surgeons will increasingly face the challenge of achieving rigid fixation of osteoporotic spines. Cement-augmented pedicle screws are the most common strategy to maximize pullout strength for fixation of osteoporotic spines. Hybrid constructs, a combination of pedicle screws and hooks, offer an alternative approach to avoid implant failure and increasing construct stability when placing instrumentation in the osteoporotic spine. Biomechanical studies of either cement-augmented pedicle screws or combined pedicle screws and hooks for osteoporotic spine have demonstrated superior results compared to pedicle screws only in terms of improving implant pullout strength. However, few clinical investigation to date has focused on comparing surgical results of the cement-augmented pedicle screws (CPS) and hybrid construct (HC) techniques. The goal of the retrospective cohort study was to compare the surgical outcomes and surgery-, patient- and implant-related complications between the CPS and HC techniques for osteoporotic vertebral fractures in the thoracic or lumbar spine.

Official Title
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Posterior Instrumentation for Osteoporotic Fractures in the Thoracic or Lumbar Spine: A Retrospective Comparison Between Cement Augmented Pedicle Screws and Hybrid Constructs of Pedicle Screws and Hooks

Conditions
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Osteoporosis

Intervention / Treatment
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* Procedure: Cement-augmented Pedicle Screws (CPS)
* Procedure: Hybrid Construct (HC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgical treatment with CPS or HC of pedicle screws and hooks for osteoporotic fractures in the thoracic or lumbar spine Received a minimum of 2-year follow-up Exclusion Criteria: T-scores greater than -2.5 Cancer metastasis Chronic osteomyelitis Failure to complete the questionnaires or radiographic examinations

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cement-augmented Pedicle Screws (CPS) Group<br> | Procedure: Cement-augmented Pedicle Screws (CPS)<br>* Patients who received surgical treatment with CPS for osteoporotic fractures in the thoracic or lumbar spine<br>|
| Hybrid Construct (HC) group<br> | Procedure: Hybrid Construct (HC)<br>* Patients who received surgical treatment with HC consisting of pedicle screws and additional hooks for osteoporotic fractures in the thoracic or lumbar spine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Failure | Implant failure was defined as pull-out or breakage of the implants on plain X-ray film. | Postoperative 1 year | 
| Kyphotic Angle | Cobb's method was used to measure the regional kyphotic angle | Preoperative | 
| Kyphotic Angle | Cobb's method was used to measure the regional kyphotic angle | Postoperative 1 month. | 
| Kyphotic Angle | Cobb's method was used to measure the regional kyphotic angle | Postoperative 2 months. | 
| Kyphotic Angle | Cobb's method was used to measure the regional kyphotic angle | Postoperative 3 months. | 
| Kyphotic Angle | Cobb's method was used to measure the regional kyphotic angle | Postoperative 6 months. | 
| Kyphotic Angle | Cobb's method was used to measure the regional kyphotic angle | Postoperative 12 months. | 
| Visual Analogue Scale (VAS) | Functional outcomes, Back pain evaluated | Preoperative | 
| Visual Analogue Scale (VAS) | Functional outcomes, Back pain evaluated | Postoperative 1 month. | 
| Visual Analogue Scale (VAS) | Functional outcomes, Back pain evaluated | Postoperative 2 months. | 
| Visual Analogue Scale (VAS) | Functional outcomes, Back pain evaluated | Postoperative 3 months. | 
| Visual Analogue Scale (VAS) | Functional outcomes, Back pain evaluated | Postoperative 6 months. | 
| Visual Analogue Scale (VAS) | Functional outcomes, Back pain evaluated | Postoperative 12 months. | 
| Oswestry Disability Index (ODI) | Functional outcomes, Disability evaluated | Preoperative | 
| Oswestry Disability Index (ODI) | Functional outcomes, Disability evaluated | Postoperative 1 month. | 
| Oswestry Disability Index (ODI) | Functional outcomes, Disability evaluated | Postoperative 2 months. | 
| Oswestry Disability Index (ODI) | Functional outcomes, Disability evaluated | Postoperative 3 months. | 
| Oswestry Disability Index (ODI) | Functional outcomes, Disability evaluated | Postoperative 6 months. | 
| Oswestry Disability Index (ODI) | Functional outcomes, Disability evaluated | Postoperative 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracolumbar fracture, Cement augmentation, Pedicle Screw, Hybrid Construct, Hook