NCT05130242

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

October 19, 2021

Last Update Submit

November 22, 2021

Conditions

Osteoporosis

Keywords

Thoracolumbar fractureCement augmentationHookPedicle ScrewHybrid Construct

Outcome Measures

Primary Outcomes (19)

  • 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.

Study Arms (2)

Cement-augmented Pedicle Screws (CPS) Group

Procedure: Cement-augmented Pedicle Screws (CPS)

Hybrid Construct (HC) group

Procedure: Hybrid Construct (HC)

Interventions

Cement-augmented Pedicle Screws (CPS)PROCEDURE

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

Cement-augmented Pedicle Screws (CPS) Group
Hybrid Construct (HC)PROCEDURE

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

Hybrid Construct (HC) group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who underwent surgical treatment with CPS or HC of pedicle screws and hooks for osteoporotic fractures in the thoracic or lumbar spine in our hospital from January 2011 through December 2015

You may qualify if:

  • 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

You may not qualify if:

  • T-scores greater than -2.5
  • Cancer metastasis
  • Chronic osteomyelitis
  • Failure to complete the questionnaires or radiographic examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Shih-Tien Wang, MD

CONTACT

886-2-28757557stwang@vghtpe.gov.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 23, 2021

Study Start

January 21, 2021

Primary Completion

January 21, 2022

Study Completion

January 21, 2022

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

TW(1)