Prognostic Factors for ACDF With BAK/C in Cervical Disc Disease

NCT ID: NCT07069114

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-12-31

Brief Summary

This retrospective study aimed to identify predictive prognostic factors for treatment outcomes in patients with cervical degenerative disc disease (CDDD). The study analyzed data from 80 patients who underwent anterior cervical discectomy and fusion (ACDF) with the Bagby and Kuslich (BAK/C) technique. Patients were stratified into two groups based on clinical outcomes at a 3-year follow-up, and logistic regression was used to determine which factors, such as age and bone mineral density, were independent predictors of poor recovery.

Detailed Description

Cervical degenerative disc disease (CDDD) is a prevalent condition causing significant pain and neurological dysfunction. Anterior cervical discectomy and fusion (ACDF) combined with the Bagby and Kuslich (BAK/C) interbody fusion technique is an established surgical treatment, but patient outcomes vary. This study was designed to address a gap in the literature by retrospectively analyzing both surgical and patient-related variables over a 3-year follow-up period to understand the factors influencing treatment success. A cohort of 80 patients treated between January and December 2020 was identified. Patients were divided into a "favorable outcome" group and a "poor outcome" group based on post-operative pain relief and neurological improvement (JOA score). The study's primary objective was to use multivariate logistic regression analysis to identify independent risk factors (e.g., age, bone mineral density, disease severity, postoperative complications) associated with poor outcomes. The findings aim to provide evidence-based insights to help optimize patient selection and treatment strategies for ACDF with BAK/C fusion.

Conditions

Cervical Spondylosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Favorable Outcome Group (Control Group)

Patients (n=52) who underwent ACDF with BAK/C and achieved good neurological recovery, defined as Visual Analog Scale (VAS) ≤ 2 combined with a Japanese Orthopaedic Association (JOA) score improvement of ≥4 points at 3-year follow-up.

Anterior Cervical Discectomy and Fusion with BAK/C Interbody Fusion

Intervention Type: PROCEDURE

The surgical intervention consisted of anterior cervical discectomy and fusion (ACDF). Patients were placed under general anesthesia in a supine position with slight neck extension. A standard right anterior cervical approach was utilized to expose the affected vertebral levels. Following the removal of the degenerated intervertebral disc and osteophytes, the interbody space was prepared. A Bagby and Kuslich (BAK/C) interbody fusion cage, filled with autogenous bone fragments, was implanted to facilitate fusion. In cases of multi-level surgery, an anterior cervical plate was selectively applied for enhanced stability based on intraoperative assessment. Postoperatively, all patients were required to wear a Philadelphia hard neck brace for a period of 2 months.

Poor Outcome Group (Observation Group)

Patients (n=28) who underwent ACDF with BAK/C and demonstrated minimal or worsened neurological recovery, defined as VAS \> 2 with a JOA improvement of \<2 points or neurological deterioration at 3-year follow-up.

Anterior Cervical Discectomy and Fusion with BAK/C Interbody Fusion

Intervention Type: PROCEDURE

The surgical intervention consisted of anterior cervical discectomy and fusion (ACDF). Patients were placed under general anesthesia in a supine position with slight neck extension. A standard right anterior cervical approach was utilized to expose the affected vertebral levels. Following the removal of the degenerated intervertebral disc and osteophytes, the interbody space was prepared. A Bagby and Kuslich (BAK/C) interbody fusion cage, filled with autogenous bone fragments, was implanted to facilitate fusion. In cases of multi-level surgery, an anterior cervical plate was selectively applied for enhanced stability based on intraoperative assessment. Postoperatively, all patients were required to wear a Philadelphia hard neck brace for a period of 2 months.

Interventions

Anterior Cervical Discectomy and Fusion with BAK/C Interbody Fusion

The surgical intervention consisted of anterior cervical discectomy and fusion (ACDF). Patients were placed under general anesthesia in a supine position with slight neck extension. A standard right anterior cervical approach was utilized to expose the affected vertebral levels. Following the removal of the degenerated intervertebral disc and osteophytes, the interbody space was prepared. A Bagby and Kuslich (BAK/C) interbody fusion cage, filled with autogenous bone fragments, was implanted to facilitate fusion. In cases of multi-level surgery, an anterior cervical plate was selectively applied for enhanced stability based on intraoperative assessment. Postoperatively, all patients were required to wear a Philadelphia hard neck brace for a period of 2 months.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥ 18, regardless of gender.
• Diagnosed with degenerative cervical intervertebral disc disease based on clinical and imaging findings.
• Significant pain and symptoms impacting quality of life, requiring surgery.
• Undergoing anterior decompression and BAK/C interbody fusion.
• Minimum 3-year follow-up data available.

Exclusion Criteria

• Serious cervical conditions (e.g., fracture, infection, tumor).
• Previous cervical surgery or other treatments.
• Pregnant or lactating women.

• Minimum Eligible Age: 36 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liang Hao

OTHER

Sponsor Role: lead

Responsible Party

Liang Hao

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Third Hospital of Shijiazhuang

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2023-B056

Identifier Type: -

Identifier Source: org_study_id