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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05130242
• Other study ID #: 2021-01-030CC
• Status: Recruiting
• Start date: January 21, 2021
• Est. completion date: January 21, 2022

Study information

• Verified date: November 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Shih-Tien Wang, MD
• Phone: 886-2-28757557
• Email: stwang[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 21, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporotic Fractures

Intervention

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

Locations

Country	Name	City	State
Taiwan	Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Failure	Implant failure was defined as pull-out or breakage of the implants on plain X-ray film.	Postoperative 1 year
Primary	Kyphotic Angle	Cobb's method was used to measure the regional kyphotic angle	Preoperative
Primary	Kyphotic Angle	Cobb's method was used to measure the regional kyphotic angle	Postoperative 1 month.
Primary	Kyphotic Angle	Cobb's method was used to measure the regional kyphotic angle	Postoperative 2 months.
Primary	Kyphotic Angle	Cobb's method was used to measure the regional kyphotic angle	Postoperative 3 months.
Primary	Kyphotic Angle	Cobb's method was used to measure the regional kyphotic angle	Postoperative 6 months.
Primary	Kyphotic Angle	Cobb's method was used to measure the regional kyphotic angle	Postoperative 12 months.
Primary	Visual Analogue Scale (VAS)	Functional outcomes, Back pain evaluated	Preoperative
Primary	Visual Analogue Scale (VAS)	Functional outcomes, Back pain evaluated	Postoperative 1 month.
Primary	Visual Analogue Scale (VAS)	Functional outcomes, Back pain evaluated	Postoperative 2 months.
Primary	Visual Analogue Scale (VAS)	Functional outcomes, Back pain evaluated	Postoperative 3 months.
Primary	Visual Analogue Scale (VAS)	Functional outcomes, Back pain evaluated	Postoperative 6 months.
Primary	Visual Analogue Scale (VAS)	Functional outcomes, Back pain evaluated	Postoperative 12 months.
Primary	Oswestry Disability Index (ODI)	Functional outcomes, Disability evaluated	Preoperative
Primary	Oswestry Disability Index (ODI)	Functional outcomes, Disability evaluated	Postoperative 1 month.
Primary	Oswestry Disability Index (ODI)	Functional outcomes, Disability evaluated	Postoperative 2 months.
Primary	Oswestry Disability Index (ODI)	Functional outcomes, Disability evaluated	Postoperative 3 months.
Primary	Oswestry Disability Index (ODI)	Functional outcomes, Disability evaluated	Postoperative 6 months.
Primary	Oswestry Disability Index (ODI)	Functional outcomes, Disability evaluated	Postoperative 12 months.