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NCT Number: NCT07069114

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

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.

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Key information

Conditions

Cervical Spondylosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylosis

Age range

36 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Hospital of Shijiazhuang

Shijiazhuang, Hebei, 050012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Identification of Independent Risk Factors for Poor Surgical Outcomes

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

    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".

Secondary outcomes

  1. Change in Neurological Function

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

    Assessed using the Japanese Orthopaedic Association (JOA) scoring system, which ranges from 0 (severe impairment) to 17 (normal function).

  2. Radiological Fusion Rate

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

    Assessed via X-ray and CT scans. Firm fusion was defined as segmental motion <2 degrees on extension-flexion radiographs and bridging trabecular bone across ≥50% of the graft-host interface. The rate of pseudoarthrosis (non-fusion) was reported as a key radiological outcome.

  3. Change in Intervertebral Height

    Time frame: 1 week postoperative and 3-year final follow-up

    Measured from lateral X-ray images. The change was calculated as the difference between the immediate postoperative height and the height at the final follow-up.

  4. Incidence of Postoperative Complications

    Time frame: Assessed throughout the 3-year follow-up period

    Number and type of adverse events recorded, including C5 palsy and pseudoarthrosis, categorized as intraoperative, early postoperative (<30 days), or late postoperative (>30 days).

  5. Bone Mineral Density (BMD)

    Time frame: Baseline (Preoperative)

    Measured preoperatively using dual-energy X-ray absorptiometry (DXA) at the lumbar spine and reported as a T-score to assess bone quality.

Sponsors and collaborators

Lead sponsor

Liang Hao

Other

Registry information

Official study title

Impact of Prognostic Factors on Treatment Outcomes in Patients With Cervical Degenerative Disc Disease Undergoing Anterior Cervical Discectomy and Fusion With the Bagby and Kuslich (BAK/C) Technique: A Retrospective Cohort Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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