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

NCT07069114 | Completed

• 1 other identifier: 2023-B056
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spondylosis

Outcome Measures

Primary Outcomes (1)

• Identification of Independent Risk Factors for Poor Surgical Outcomes

  To identify predictors of poor treatment outcome using multivariate logistic regression analysis. The analysis evaluated variables including age, bone mineral density, baseline disease severity (initial JOA score), postoperative complications, and postoperative care. The outcome was being classified into the "Poor Outcome Group".

  Assessed based on data collected up to the 3-year final follow-up

Secondary Outcomes (5)

• Change in Neurological Function

  Baseline (preoperative), 1 week postoperative, 6 months postoperative, and 3-year final follow-up

• Radiological Fusion Rate

  Assessed at 6 months and at the 3-year final follow-up

• Change in Intervertebral Height

  1 week postoperative and 3-year final follow-up

• Incidence of Postoperative Complications

  Assessed throughout the 3-year follow-up period

• Bone Mineral Density (BMD)

  Baseline (Preoperative)

Study Arms (2)

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.

Procedure: Anterior Cervical Discectomy and Fusion with BAK/C Interbody Fusion

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.

Procedure: Anterior Cervical Discectomy and Fusion with BAK/C Interbody Fusion

Interventions

Anterior Cervical Discectomy and Fusion with BAK/C Interbody Fusion 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.

Favorable Outcome Group (Control Group); Poor Outcome Group (Observation Group)

Eligibility Criteria

• Age: 36 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of hospitalized patients diagnosed with symptomatic cervical degenerative disc disease who were treated at The Third Hospital of Shijiazhuang. The cohort was derived from a consecutive series of patients who underwent anterior cervical discectomy and fusion (ACDF) with the BAK/C technique between January and December 2020. The final included sample of 80 patients had a mean age of 55.36 years (range 36-75) and were selected based on specific inclusion/exclusion criteria, including the absence of prior cervical surgery.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Liang Hao: lead

Study Sites (1)

The Third Hospital of Shijiazhuang

Shijiazhuang, Hebei, 050012, China

Location

MeSH Terms

Conditions

Spondylosis

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

CN (1)