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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05130242
Enrollment
200
Registered
2021-11-23
Start date
2021-01-21
Completion date
2022-01-21
Last updated
2021-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Thoracolumbar fracture, Cement augmentation, Hook, Pedicle Screw, Hybrid Construct

Brief summary

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

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.

Interventions

PROCEDURECement-augmented Pedicle Screws (CPS)

Patients who received surgical treatment with CPS for osteoporotic fractures in the thoracic or lumbar spine

PROCEDUREHybrid Construct (HC)

Patients who received surgical treatment with HC consisting of pedicle screws and additional hooks for osteoporotic fractures in the thoracic or lumbar spine

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Implant FailurePostoperative 1 yearImplant failure was defined as pull-out or breakage of the implants on plain X-ray film.
Kyphotic AnglePreoperativeCobb's method was used to measure the regional kyphotic angle
Visual Analogue Scale (VAS)PreoperativeFunctional outcomes, Back pain evaluated
Oswestry Disability Index (ODI)PreoperativeFunctional outcomes, Disability evaluated

Countries

Taiwan

Contacts

Primary ContactShih-Tien Wang, MD
stwang@vghtpe.gov.tw886-2-28757557

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026