Cervical SpondylosisNCT07069114
Prognostic Factors for ACDF With BAK/C in Cervical Disc Disease
An observational study of Cervical Spondylosis, run by Liang Hao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 75 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Anterior Cervical Discectomy and Fusion with BAK/C Interbody Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Serious cervical conditions (e.g., fracture, infection, tumor).
- Previous cervical surgery or other treatments.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- Anterior Cervical Discectomy and Fusion with BAK/C Interbody Fusion
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cervical Discectomy and Fusion with BAK/C Interbody FusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Anterior Cervical Discectomy and Fusion with BAK/C Interbody Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Assessed based on data collected up to the 3-year final follow-up
Secondary outcomes (5)
Change in Neurological Function
Assessed using the Japanese Orthopaedic Association (JOA) scoring system, which ranges from 0 (severe impairment) to 17 (normal function).
Measured: Baseline (preoperative), 1 week postoperative, 6 months postoperative, and 3-year final follow-up
Radiological Fusion Rate
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.
Measured: Assessed at 6 months and at the 3-year final follow-up
Change in Intervertebral Height
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.
Measured: 1 week postoperative and 3-year final follow-up
Incidence of Postoperative Complications
Number and type of adverse events recorded, including C5 palsy and pseudoarthrosis, categorized as intraoperative, early postoperative (<30 days), or late postoperative (>30 days).
Measured: Assessed throughout the 3-year follow-up period
Bone Mineral Density (BMD)
Measured preoperatively using dual-energy X-ray absorptiometry (DXA) at the lumbar spine and reported as a T-score to assess bone quality.
Measured: Baseline (Preoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liang Hao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liang Hao, The Third Hospital of Shijiazhuang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069114
- Sponsor's protocol ID
- 2023-B056
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07069114
- Acronym / sponsor ID
- 2023-B056
- Conditions
- Cervical Spondylosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Liang HaoUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Favorable Outcome Group (Control Group) | – | Procedure: Anterior Cervical Discectomy and Fusion with BAK/C Interbody FusionPatients (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. |
| Poor Outcome Group (Observation Group) | – | Procedure: Anterior Cervical Discectomy and Fusion with BAK/C Interbody FusionPatients (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. |
Who may qualify
- Ages
- 36 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Serious cervical conditions (e.g., fracture, infection, tumor).
- Previous cervical surgery or other treatments.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Cervical Discectomy and Fusion with BAK/C Interbody FusionThe 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. | Procedure or surgery | Favorable Outcome Group (Control Group), Poor Outcome Group (Observation Group) |
Primary outcome
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".
5 secondary outcomes
Change in Neurological Function
Time frame: Baseline (preoperative), 1 week postoperative, 6 months postoperative, and 3-year final follow-up
Radiological Fusion Rate
Time frame: Assessed at 6 months and at the 3-year final follow-up
Change in Intervertebral Height
Time frame: 1 week postoperative and 3-year final follow-up
Incidence of Postoperative Complications
Time frame: Assessed throughout the 3-year follow-up period
Bone Mineral Density (BMD)
Time frame: Baseline (Preoperative)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
Related trials for Cervical Spondylosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
Recruiting
Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
Cervical Spondylosis
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylosis, run by Liang Hao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Independent Risk Factors for Poor Surgical Outcomes (time frame: Assessed based on data collected up to the 3-year final follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.