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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Anticipated): January 21, 2022
• Study Completion (Anticipated): January 21, 2022

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Thoracolumbar fracture; Cement augmentation; Hook; Pedicle Screw; Hybrid Construct
• Additional Relevant MeSH Terms: Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporotic Fractures
• Other Study ID Numbers: 2021-01-030CC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No