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

T

Taipei Veterans General Hospital

Status

Unknown

Conditions

Osteoporosis

Treatments

Procedure: Hybrid Construct (HC)
Procedure: Cement-augmented Pedicle Screws (CPS)

Study type

Observational

Funder types

Other

Identifiers

NCT05130242
2021-01-030CC

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Cement-augmented Pedicle Screws (CPS) Group
Treatment:
Procedure: Cement-augmented Pedicle Screws (CPS)
Hybrid Construct (HC) group
Treatment:
Procedure: Hybrid Construct (HC)

Trial contacts and locations

1

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Central trial contact

Shih-Tien Wang, MD

Data sourced from clinicaltrials.gov

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