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

NCT ID: NCT05130242

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-21

Study Completion Date

2022-01-21

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.

Conditions

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Osteoporosis

Keywords

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Thoracolumbar fracture Cement augmentation Hook Pedicle Screw Hybrid Construct

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cement-augmented Pedicle Screws (CPS) Group

Cement-augmented Pedicle Screws (CPS)

Intervention Type PROCEDURE

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

Hybrid Construct (HC) group

Hybrid Construct (HC)

Intervention Type PROCEDURE

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

Interventions

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Cement-augmented Pedicle Screws (CPS)

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

Intervention Type PROCEDURE

Hybrid 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

Intervention Type PROCEDURE

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shih-Tien Wang, MD

Role: CONTACT

Phone: 886-2-28757557

Email: [email protected]

Facility Contacts

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Shih-Tien Wang, MD

Role: primary

Other Identifiers

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2021-01-030CC

Identifier Type: -

Identifier Source: org_study_id