Clinical trial NCT05130242: A Retrospective Comparison Between CPS and HC Techniques for Osteoporotic Fractures in the Thoracic or Lumbar Spine
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Keywords: Thoracolumbar fracture
Cement augmentation
Hook
Pedicle Screw
Hybrid Construct
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-11-23
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implant Failure
timeFrame: Postoperative 1 year
measure: Kyphotic Angle
timeFrame: Preoperative
measure: Kyphotic Angle
timeFrame: Postoperative 1 month.
measure: Kyphotic Angle
timeFrame: Postoperative 2 months.
measure: Kyphotic Angle
timeFrame: Postoperative 3 months.
measure: Kyphotic Angle
timeFrame: Postoperative 6 months.
measure: Kyphotic Angle
timeFrame: Postoperative 12 months.
measure: Visual Analogue Scale (VAS)
timeFrame: Preoperative
measure: Visual Analogue Scale (VAS)
timeFrame: Postoperative 1 month.
measure: Visual Analogue Scale (VAS)
timeFrame: Postoperative 2 months.
measure: Visual Analogue Scale (VAS)
timeFrame: Postoperative 3 months.
measure: Visual Analogue Scale (VAS)
timeFrame: Postoperative 6 months.
measure: Visual Analogue Scale (VAS)
timeFrame: Postoperative 12 months.
measure: Oswestry Disability Index (ODI)
timeFrame: Preoperative
measure: Oswestry Disability Index (ODI)
timeFrame: Postoperative 1 month.
measure: Oswestry Disability Index (ODI)
timeFrame: Postoperative 2 months.
measure: Oswestry Disability Index (ODI)
timeFrame: Postoperative 3 months.
measure: Oswestry Disability Index (ODI)
timeFrame: Postoperative 6 months.
measure: Oswestry Disability Index (ODI)
timeFrame: Postoperative 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital
Study officials:
References: