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

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05130242
Collaborator
(none)
200
1
12
16.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cement-augmented Pedicle Screws (CPS)
  • Procedure: Hybrid Construct (HC)

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Jan 21, 2021
Anticipated Primary Completion Date :
Jan 21, 2022
Anticipated Study Completion Date :
Jan 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Cement-augmented Pedicle Screws (CPS) Group

Procedure: Cement-augmented Pedicle Screws (CPS)
Patients who received surgical treatment with CPS for osteoporotic fractures in the thoracic or lumbar spine

Hybrid Construct (HC) group

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

Outcome Measures

Primary Outcome Measures

  1. Implant Failure [Postoperative 1 year]

    Implant failure was defined as pull-out or breakage of the implants on plain X-ray film.

  2. Kyphotic Angle [Preoperative]

    Cobb's method was used to measure the regional kyphotic angle

  3. Kyphotic Angle [Postoperative 1 month.]

    Cobb's method was used to measure the regional kyphotic angle

  4. Kyphotic Angle [Postoperative 2 months.]

    Cobb's method was used to measure the regional kyphotic angle

  5. Kyphotic Angle [Postoperative 3 months.]

    Cobb's method was used to measure the regional kyphotic angle

  6. Kyphotic Angle [Postoperative 6 months.]

    Cobb's method was used to measure the regional kyphotic angle

  7. Kyphotic Angle [Postoperative 12 months.]

    Cobb's method was used to measure the regional kyphotic angle

  8. Visual Analogue Scale (VAS) [Preoperative]

    Functional outcomes, Back pain evaluated

  9. Visual Analogue Scale (VAS) [Postoperative 1 month.]

    Functional outcomes, Back pain evaluated

  10. Visual Analogue Scale (VAS) [Postoperative 2 months.]

    Functional outcomes, Back pain evaluated

  11. Visual Analogue Scale (VAS) [Postoperative 3 months.]

    Functional outcomes, Back pain evaluated

  12. Visual Analogue Scale (VAS) [Postoperative 6 months.]

    Functional outcomes, Back pain evaluated

  13. Visual Analogue Scale (VAS) [Postoperative 12 months.]

    Functional outcomes, Back pain evaluated

  14. Oswestry Disability Index (ODI) [Preoperative]

    Functional outcomes, Disability evaluated

  15. Oswestry Disability Index (ODI) [Postoperative 1 month.]

    Functional outcomes, Disability evaluated

  16. Oswestry Disability Index (ODI) [Postoperative 2 months.]

    Functional outcomes, Disability evaluated

  17. Oswestry Disability Index (ODI) [Postoperative 3 months.]

    Functional outcomes, Disability evaluated

  18. Oswestry Disability Index (ODI) [Postoperative 6 months.]

    Functional outcomes, Disability evaluated

  19. Oswestry Disability Index (ODI) [Postoperative 12 months.]

    Functional outcomes, Disability evaluated

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital Taipei Taiwan

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT05130242
Other Study ID Numbers:
  • 2021-01-030CC
First Posted:
Nov 23, 2021
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taipei Veterans General Hospital, Taiwan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2021