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

• Conditions: Osteoporosis
• Interventions: Procedure: Cement-augmented Pedicle Screws (CPS); Procedure: Hybrid Construct (HC)

• Registration Number: NCT05130242
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2021-01-21
• Study First Submitted: 2021-10-19
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Study First Posted: 2021-11-23
• Last Update Posted: 2021-11-23
• Primary Completion: 2022-01-21
• Study Completion: 2022-01-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cement-augmented Pedicle Screws (CPS) Group	Cement-augmented Pedicle Screws (CPS)	-
Hybrid Construct (HC) group	Hybrid Construct (HC)	-

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	Postoperative 12 months.	Functional outcomes, Back pain evaluated
Oswestry Disability Index (ODI)	Postoperative 12 months.	Functional outcomes, Disability evaluated
Implant Failure	Postoperative 1 year	Implant failure was defined as pull-out or breakage of the implants on plain X-ray film.
Kyphotic Angle	Postoperative 12 months.	Cobb's method was used to measure the regional kyphotic angle

Trial Locations

Locations (1)

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan