An interventional study of Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention in Degenerative Spinal Disease, Elderly Patients and Spinal Fusion Acquired, sponsored by Xijing Hospital. Not yet recruiting at 2 sites in China. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
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.
Population ageing is rapid progressing globally. In the United States, the number of people over the age of 80 is expected to grow from 1.9% in 2020 to 4.3% in 2050. According to the Statistical Communique on the Development of Civil Affairs in 2023 issued by the Ministry of Civil Affairs in 2024, the elderly population aged 65 and above in China is 216.76 million, accounting for 15.4% of the total population. Spinal degenerative diseases are the most common diseases among the elderly population. The prevalence of spinal degenerative diseases over 65 years old is about 56%, and there are about 121 million patients in China. Spinal degenerative diseases, including cervical spondylosis, cervical spinal stenosis, lumbar disc herniation, lumbar spinal stenosis, degenerative scoliosis, et al., which can lead to significant nerve compression, pain, neurological dysfunction, and mobility and endurance reduction, leading to reduced quality of life. Elderly patients preferentially choose non-surgical treatment such as drug intervention, but most conservative treatment methods have limited efficacy and cannot completely relieve nerve compression. Spinal fusion surgery is the most fundamental solution to the treatment of spinal degenerative diseases. Because of the elderly patients with multiple diseases, multi-drug use, multi-organ dysfunction, therefore, the perioperative safety management of such patients is a difficult problem faced by clinicians.
Preoperative high-risk factor evaluation and pre-enhanced recovery after surgery (Pre ERAS) are effective preoperative optimization strategies to benefit elderly patients. Patients are comprehensively evaluated before surgery by multidisciplinary consultation group to assess the high risk factors of spinal fusion surgery. On this basis, multidisciplinary intervention, exercise, nutritional support and psychological intervention were carried out to increase patients' preoperative physiological reserve, reduce the incidence of postoperative adverse events, and ultimately improve patients' perioperative functional status and prognosis. However, there is still a significant lack of unified understanding and willingness to implement preoperative screening and surgical management for elderly patients.
On the basis of "Chinese Expert Consensus on Multidisciplinary Evaluation of Perioperative Period in Elderly Spinal Surgery Patients", this study intends to further specify the concept of Pre ERAS for diagnosis and treatment measures, and form an operable Pre ERAS protocol. Through multi-center, prospective clinical study, to comprehensively evaluate the comprehensive impact of preoperative high-risk factor assessment combined with Pre ERAS measures on the clinical prognosis of elderly patients undergoing spinal fusion surgery, which lays an evidence-based medical foundation for the extensive application of this concept and measures in clinical practice.
The overall aim of this work is to evaluate the effects of preoperative risk factors and Pre ERAS on clinical outcomes in elderly (≥75 years) spinal fusion patients.
This study is a multi-center, prospective, randomized controlled clinical trial including a total of 2500 patients in the experimental group and the control group, respectively. The research centers include: Shenzhen Hospital of Southern Medical University, the Second Xiangya Hospital of Central South University, and Shanghai General Hospital. Patients were recruited according to inclusion criteria and exclusion criteria. The experimental group received Pre ERAS during perioperative period, while the control group received conventional ERAS during perioperative period. According to the clinical study protocol, patients were subjected to perioperative intervention, clinical follow-up, results recorded, adverse events were discovered and recorded in time and reported according to regulations, and cases meeting the exclusion criteria were excluded. This study will start in October 2024. The recruitment period will be 12 months, with a follow-up of 12 months. The results of the study will be expected in October 2027.
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 60 across 106 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention
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.
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
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
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
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
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
Spinal fusion rates
The spinal fusion is evatluted by compute tomography (CT) scanning to reflects the effectiveness of Pre ERAS on bone healing after surgical intervention. The spinal fusion criteria is defined as the continuous callus is detected on CT radiograph at the surgical intervented spinal segments. The spinal fusion rates is calculated as the number of the fused setgments after surgical intervention divided by the number of the total surgical intervented segments.
Time frame: 24 weeks postoperation
Length of hospital stay
The length of hospital stay is the total time of the patient spended in hospital for medical treatment. This time starts from patient admission and ended when patient discharge. The discharge criteria: 1. The patient satified with the outcomes of spinal fusion intervention; 2. The spinal fusion intervention achieved peroperative symptoms relive and function recovery; 3. No further medical intervention is needed; 4. No surgerical complications;
Time frame: 2 weeks postoperation
Discharge rate
Time frame: 2 weeks postoperation
Readmission rate
Time frame: 4 weeks postoperation
90-day unplanned readmission rates
Any admission which was within 90 days of the previous discharge (index admission) was counted as 90-day unplanned readmission.
Time frame: 90 days postoperation
Plan to share: No
Start is estimated for Oct 2024; primary completion for Dec 2026, 26 months later.
Of 40 non-industry interventional studies with no phase under Spinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 26 months is close to that.
Counting every sponsor, half of 43 studies reached it within 26 months; a quarter within 16 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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