Health TrialsbyHealthPanel

Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery

ConditionsDegenerative Spinal DiseaseElderly PatientsSpinal Fusion Acquired
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorXijing Hospital

About this trial

This study aims to evaluate the value of preoperative risk factor evaulation combined with perioperative ERAS measures in improving the clinical prognosis of elderly patients undergo the spinal fusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Age ≥75 years old;

2.Have degenerative spinal diseases, including cervical, thoracic and lumbar spine diseases;

3.With severe neurological symptoms fail to conservative treatment and have to undergo the spinal fusion surgery;

4.No serious cognitive impairment (MoCA score ≥8);

Disqualifiers

1.Patients who could not cooperate with doctors to complete preoperative evaluation and postoperative follow-up;

2.Patients requiring spinal intervention due to spinal infection, fracture or metastatic disease;

3.Patients with cerebrovascular accidents in the last 30 days;

4.Patients with hepatic encephalopathy or acute active hepatitis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention

    Combination product

    The operative risk factors are multidisciplinary evaluated and the corresponded multimodal measures are used to optimize the whole condition of the elderly patient undergo spinal fusion surgery for his/her safty, early and fully recovery.

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: Perioperative Pre ERAS groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Comprehensive Complication Index

The Comprehensive Complication Index (CCI) is based on the complication grading by the Clavien-Dindo Classification and captures every complication that occurred after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death) and reflects the gravity of this overall complication burden on the patients. CCI can be calculated using online CCI calculator (https://cci-calculator.com/cciCalculator), which is a tool to support the assessment of patients' overall morbidity after an intervention.

Time frame
24 weeks postoperation

Secondary outcomes

1

Neck disability index (NDI) score/Oswestry disability index (ODI) score

The Neck disability index (NDI) score reflects the neck-related functional status of patients with cervical spine pathology and response to the surigcal treatment. The NDI score is assessed using NDI questionnaire and the total NDI score ranges from 0 to 50 points, with the highest socre (50 pionts) means complete disability and the lowest socre (0 points) means no disability. The Oswestry disability index (ODI) score reflects back-related functional status of patients with lumbar spine pathology and response to the surgical treatment. The ODI score is assessed using ODI questionnaire. The total ODI score is reported from 0 to 100, with the higher score reflects higher disability and lower functional status, while the lower score reflects lower disability and higher functional status.

Time frame
24 weeks postoperation
2

North American Spine Satisfaction (NASS) Score

The patient satisfaction after spinal fusion intervention is assessed using North American Spine Satisfaction (NASS) questionnaire. NASS score ranges from 1 to 4, the lowest score means the highest level of satisfication while the highest score means the lowest level of satisfication. Score 1 is defined as "Surgery met my expectations." Score 2 is defined as "I did not improve as much as I had hoped but I would undergo the same operation for the same results." Score 3 is defined as "Surgery helped but I would not undergo the same operation for the same results," Score 4 is defined as "I am the same or worse as compared to before surgery."

Time frame
24 weeks postoperation
3

Japanese Orthopaedic Association (JOA) score

The severity of cervical compression myelopathy before and after surgery of the patients is evaluated using the Japanese Orthopaedic Association (JOA) scale, with the total JOA score ranges from 0 to 17. If the JOA score is larger than 13, the severity defines as mild. If the JOA score is 9\~13, the severity defines as moderate. If the JOA score is less than 9, the severity defines as severe.

Time frame
24 weeks postoperation
4

Bone minral density (BMD) evaluation

The bone minral density (BMD) will be tested using Dual Energy X-ray Absorptiometry (DEXA) to assess the bone quality of the patients included in this study before and after spinal fusion intervention.

Time frame
24 weeks postoperation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xijing Hospital

Lead sponsor

Shenzhen Hospital of Southern Medical University

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Source ClinicalTrials.gov

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