A Pilot Study to Evaluate Efficacy and Safety of Anterior Cervical Discectomy and Fusion using a Patient Customized Bio-ceramic Cage

Not Applicable

Completed

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0003984
• Lead Sponsor: Yonsei University Health System, Gangnam Severance Hospital

Brief Summary

The initial application success rate after surgery, the primary endpoint, was 100%, and all 7 cases showed a perfect anatomical match between the cervical endplate and clinical medical device. The secondary endpoint confirmed no subsidence or failure of the clinical medical device occurred. So all users rated it as 'very satisfied. However, only three patients visited at 1, 3, and 6 months, one at 1 and 3 months, and one at a month, and the rest didn't. It was a bit disappointing in the evaluation.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-05-25
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Adult men and women aged 19 to 79 year-old. (19 ? Age < 80)
2. The following cervical disc disease and degenerative disease associated with the following clinical signs and symptoms require anterior cervical disc removal and fusion:
a) Symptoms and signs of radiation to one or both arms (pain, abnormal sensation or paralysis due to the distribution of certain nerve roots) or signs or symptoms related to acute or chronic myelopathy.
b) If there is an imaging diagnosis of cervical intervertebral disc herniation or/and bony scar formation(cervical spine 3-4 to cervical spine 7-thoracic spine 1) in one or both segments associated with clinical signs and symptoms of a)
3. A person who is willing to participate in the examination, and visit the hospital for all observation period.
4. A person who has voluntarily signed a written consent by hearing about the purpose and method of this clinical trial.

Exclusion Criteria

1. Symptom of radiating or myelopathy are uncertain and only cervical pain is present.
2. A person with a history of malignant tumors (if the disease has been cured and has not recurred in the past 5 years)
3. If patient is pregnant or lactating, or is a child of childbearing age, patient does not agree to maintain contraception for the duration of the trial.
4. Chronic taking steroids, corticosteroids (eg, those taking Dexamethasone 10 mg / day for more than 4 weeks)
5. Persons with history of hypersensitivity to BGS-7 and titanium.
6. Those who are diagnosed with the following diseases and considered to be difficult to proceed
a. Spinal deformity
b. Unregulated diabetes, hypertension
c. Severe mental illness, epilepsy
d. Drug abuse and severe alcoholic
e. Severe heart disease or liver dysfunction
f. Metabolic disorders: severe osteoporosis (mean T-score <-3.0 on DEXA bone mineral density), rickets, osteomalacia, pituitary dysfunction, (para-)thyroid dysfunction, limb compartment syndrome,
g. Patient with infectious disease or blood disease who are at high risk of recurrence
7. Those who are deemed to have difficulty performing the clinical trial at the discretion of the examiners (such as those who can not perform the tests required in this study)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of initial application success rate(%) of customized implant with plain radiograph

Secondary Outcome Measures

Name	Time	Method
Evaluation of application success rate(%) of customized implant with plain radiograph at 1, 3, 6 months after operation;Evaluation of Investigator Application Satisfaction;All the adverse event that occurred to subjects after application of investigational medical devices