Postoperative Neurological Recovery and Risk Factor Analysis in Patients With Paralysis Due to Spinal Metastases

Metastatic spinal tumors represent a common and devastating complication in patients with advanced solid malignancies. Up to 40% of cancer patients may develop spinal metastases during the course of their disease, often resulting in intractable pain, neurological deficits, and spinal instability. One of the most serious consequences is motor paralysis caused by metastatic epidural spinal cord compression (MESCC), which can severely impair patients' quality of life and limit their ability to receive subsequent anti-tumor therapy. Although surgical decompression and stabilization are recognized as effective strategies for relieving spinal cord compression and restoring spinal integrity, the neurological prognosis for patients who present with paralysis remains uncertain and heterogeneous.

This prospective, single-center, observational cohort study aims to evaluate the early and mid-term neurological recovery trajectories in patients with paralysis caused by spinal metastases, and to identify perioperative clinical factors associated with favorable or poor functional outcomes. The study will be conducted at Shanghai Changzheng Hospital, a tertiary care academic center with extensive experience in spinal oncology and multidisciplinary cancer care.

The investigators plan to consecutively enroll adult patients (aged 18-80) diagnosed with spinal metastatic tumors who present with motor paralysis and are deemed appropriate surgical candidates by a multidisciplinary tumor board. Participants will undergo surgical decompression and stabilization based on individualized tumor location and spinal instability. The study does not involve any investigational drug or device. All surgical procedures and adjuvant treatments (such as radiotherapy or systemic therapy) will be delivered according to standard of care.

Preoperative evaluations will include spinal imaging (MRI, CT), neurological scoring using the ASIA Impairment Scale, and assessments of systemic condition, spinal instability (SINS), and epidural compression severity (ESCC scale). Participants will be followed at 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery to monitor neurological recovery, pain control, bowel/bladder function, treatment complications, and survival.

The primary outcome is the improvement in motor function at 1 month postoperatively, quantified by changes in ASIA motor scores. Secondary outcomes include longer-term neurological recovery, progression of bowel and bladder function, quality of life, complication rates, disease progression, and survival outcomes. Additional analyses will explore the impact of variables such as timing of surgery, tumor histology, location of compression, and performance status on recovery.

This study will employ both univariate and multivariate statistical methods to identify independent predictors of postoperative neurological improvement, using logistic regression and time-to-event analyses. A total of 150 participants will be recruited, based on power analysis accounting for key covariates and anticipated dropout rates.

Through this prospective clinical registry and analysis, the study aims to provide evidence-based data to guide clinical decision-making in the management of MESCC with paralysis. The findings will help inform surgical indications, optimize timing of intervention, and support the development of prognostic tools for patient counseling. Given the limited life expectancy of many patients with advanced cancer, maximizing early neurological recovery may directly impact patient autonomy, eligibility for systemic therapy, and overall quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Paralysis; Spinal Cord Compression; Metastatic Spinal Tumors; Neurological Deficits

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Wei Xu; Phone Number: +8613761278657; Email: xuwei_spine@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients (aged 18-80 years) diagnosed with spinal metastases resulting in motor paralysis, who are scheduled to undergo surgical decompression and/or stabilization. All participants must be physically fit for surgery, provide written informed consent, and be able to complete postoperative neurological assessments. Patients with cognitive impairment, pregnancy, or incomplete follow-up data will be excluded.

Description

Inclusion Criteria:

1. Age between 18 and 80 years at the time of enrollment.
2. Clinical diagnosis of spinal metastases with resulting motor paralysis.
3. Scheduled for surgical decompression and/or spinal stabilization.
4. Medically fit to undergo surgery as determined by preoperative evaluation.
5. Ability to understand the study and provide written informed consent.
6. Willingness and ability to complete neurological and functional follow-up assessments.

Exclusion Criteria:

1. Medically unfit for surgery due to unstable comorbidities or poor general condition.
2. Pregnant or breastfeeding at the time of enrollment.
3. Significant cognitive impairment or psychiatric illness that interferes with informed consent or study participation.
4. Expected difficulty in completing follow-up assessments or anticipated loss to follow-up.
5. Missing critical baseline or follow-up data relevant to study endpoints.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with Paralysis Due to Spinal Metastases.; Patients with paralysis due to spinal metastases who undergo surgery will be included in this cohort and followed over time to assess clinical outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Achieving Improvement in ASIA Impairment Grade at 1 Month Post-Surgery	The primary outcome is the distribution and change in ASIA Impairment Grades at 1 month after surgery compared to baseline. The ASIA (American Spinal Injury Association) Impairment Scale categorizes spinal cord injury severity from Grade A (complete injury) to Grade E (normal motor and sensory function). An improvement is defined as a shift to a higher ASIA grade (e.g., from C to D or D to E). The proportion of patients showing at least 1-grade improvement will be calculated to reflect early neurological recovery following surgical decompression and stabilization for metastatic spinal cord compression.	Baseline (preoperative) to 1 month postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex of Participant	Sex (male or female) will be recorded as a baseline demographic variable and may be analyzed for its association with neurological recovery after spinal metastasis surgery.	preoperative
Age of Participant	The patient's age at the time of surgery (in years) will be recorded to assess its relationship with postoperative neurological function and general prognosis.	preoperative
ECOG Performance Status	Preoperative physical condition will be assessed using ASA (American Society of Anesthesiologists) classification and ECOG (Eastern Cooperative Oncology Group) score to explore their potential as predictors of surgical recovery and survival.	preoperative
Time from Primary Cancer Diagnosis to Surgery	The interval (in months) from the initial diagnosis of the primary malignancy to the time of spinal surgery will be recorded to evaluate potential prognostic implications.	preoperative
Time from Spinal Metastasis Diagnosis to Surgery	The time between the diagnosis of spinal metastasis and the surgical intervention will be measured in months to assess whether earlier surgical timing influences neurological outcomes.	preoperative
Histological Type of Primary Tumor	Primary tumor pathology (e.g., lung adenocarcinoma, breast carcinoma, renal cell carcinoma) will be classified according to standard oncological criteria to investigate its impact on neurological recovery and survival.	preoperative
History of Preoperative Oncologic Treatment and Surgery	Information on prior chemotherapy, radiotherapy, immunotherapy, and spinal or non-spinal surgeries will be documented to assess their association with surgical outcomes and functional recovery.	preoperative
Anatomical Location and Extent of Spinal Tumor Involvement	The vertebral level of metastasis, degree of bony destruction, and tumor extension into surrounding structures will be determined via imaging and intraoperative findings. These features will be analyzed in relation to postoperative ASIA outcomes.	preoperative
Pain Intensity Score	Pain severity will be assessed preoperatively using the Visual Analog Scale (VAS), a 0-10 scale where higher scores indicate more severe pain. VAS scores will be used as a functional and prognostic indicator.	Baseline and postoperative follow-ups (1, 3, 6 months)
: Quality of Life Assessment Using QLQ-C30	The patient's overall quality of life will be assessed using the EORTC QLQ-C30 (Version 3.0), a validated cancer-specific quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer. This instrument includes 30 items covering five functional domains (physical, role, cognitive, emotional, and social), three symptom domains (fatigue, pain, nausea/vomiting), a global health status/QoL scale, and six single items (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial impact). Each domain or symptom score will be linearly transformed to a 0-100 scale according to the EORTC scoring manual. Higher scores for functional scales represent better functioning, while higher scores for symptom scales represent more severe symptoms.	Baseline, 1, 3, 6 and 12 months postoperatively
Epidural Spinal Cord Compression (ESCC) Grade and Neurological Responsibility Level	The degree of spinal cord compression will be graded using the ESCC scale (grades 0-3) based on preoperative MRI, and the responsible spinal level (segment causing neurological dysfunction) will be identified. These factors will be analyzed for correlation with pre- and postoperative ASIA grade and recovery outcomes.	preoperative
Spinal Instability Neoplastic Score	Spinal stability will be assessed using the Spinal Instability Neoplastic Score (SINS), which includes components such as pain, lesion location, bone quality, alignment, vertebral body collapse, and posterior involvement. The total score (0-18) will help stratify patients as stable, potentially unstable, or unstable and will be evaluated for its predictive value on surgical planning and outcomes.	preoperative
PET-CT Assessment: Solid Organ Metastases and Spinal Tumor Burden	Whole-body PET-CT will be used to identify the presence of visceral organ metastases and quantify the number and distribution of involved spinal levels. This information will be used to assess systemic tumor burden and analyze its relationship with neurological recovery and overall prognosis.	preoperative
Preoperative ASIA Impairment Grade	The ASIA (American Spinal Injury Association) Impairment Grade will be documented preoperatively to classify neurological status (Grade A to E) at baseline. This will serve as both a prognostic factor and reference for postoperative recovery analysis.	preoperative
Time from Incomplete Paralysis to Surgery	For patients presenting with incomplete paralysis, the interval between the onset of neurological weakness and the surgical intervention will be recorded in hours or days to assess the relationship between timing and functional outcomes.	preoperative
Modified Ashworth Scale for Spasticity	Muscle spasticity will be graded using the Modified Ashworth Scale, a 6-point scale (0 to 4, with 1+) that measures resistance during passive soft-tissue stretching. This will assess upper motor neuron involvement and serve as a baseline and outcome parameter.	preoperative,3 month, 6 month,12 month
Duration of Surgery	The total operative time will be measured in minutes, from skin incision to wound closure. It will be used as a surrogate for surgical complexity and will be correlated with perioperative risk and outcomes.	Intraoperative
Surgical Location	The anatomical spinal region (cervical, thoracic, lumbar, sacral) and specific vertebral levels subjected to decompression will be documented. These data will be used to assess the relationship between surgical site and neurological recovery.	Intraoperative
Intraoperative Blood Loss Volume	The estimated amount of blood loss during surgery will be recorded in milliliters (mL). This variable reflects surgical invasiveness and will be correlated with transfusion requirements and postoperative complications.	Intraoperative
Use of Instrumented Internal Fixation	Whether internal fixation devices (e.g., pedicle screws, rods, cages) were implanted will be documented (yes/no). This will be used to analyze the impact of mechanical stabilization on postoperative functional recovery.	Intraoperative
Tumor Resection Method	The tumor removal method will be recorded as gross total resection, subtotal resection, or en bloc resection. The completeness of tumor removal will be analyzed for its association with local control and neurological outcomes.	Intraoperative
Postoperative Pathology Results	Pathologic confirmation of the spinal metastatic lesion, including histologic type, surgical margins, and proliferation index (e.g., Ki-67), will be recorded. Pathology findings will be used for diagnostic confirmation and correlation with prognosis.	Postoperative(within 20 days)

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital

Publications and helpful links

General Publications

• Kim CH, Chung CK, Jahng TA, Kim HJ. Resumption of ambulatory status after surgery for nonambulatory patients with epidural spinal metastasis. Spine J. 2011 Nov;11(11):1015-23. doi: 10.1016/j.spinee.2011.09.007. Epub 2011 Oct 14.
• Kato S, Hozumi T, Takeshita K, Kondo T, Goto T, Yamakawa K. Neurological recovery after posterior decompression surgery for anterior dural compression in paralytic spinal metastasis. Arch Orthop Trauma Surg. 2012 Jun;132(6):765-71. doi: 10.1007/s00402-012-1475-x. Epub 2012 Feb 14.
• Ohashi M, Hirano T, Watanabe K, Katsumi K, Shoji H, Sano A, Tashi H, Takahashi I, Wakasugi M, Shibuya Y, Endo N. Preoperative prediction for regaining ambulatory ability in paretic non-ambulatory patients with metastatic spinal cord compression. Spinal Cord. 2017 May;55(5):447-453. doi: 10.1038/sc.2016.145. Epub 2016 Oct 18.
• Li S, Zhong N, Xu W, Yang X, Wei H, Xiao J. The impact of surgical timing on neurological outcomes and survival in patients with complete paralysis caused by spinal tumours: evaluation of surgery on patients with complete paralysis due to neoplastic epidural spinal cord compression. Bone Joint J. 2019 Jul;101-B(7):872-879. doi: 10.1302/0301-620X.101B7.BJJ-2018-1173.R1.
• Li S, Zhong N, Xu W, Yang X, Wei H, Xiao J. The impact of surgical timing on neurological outcomes and survival in patients with complete paralysis caused by spinal tumours: evaluation of surgery on patients with complete paralysis due to neoplastic epidural spinal cord compression. Bone Joint J. 2019 Jul;101-B(7):872-879.
• Younsi A, Riemann L, Ishak B, Scherer M, Unterberg AW, Zweckberger K. Feasibility of salvage decompressive surgery for pending paralysis due to metastatic spinal cord compression. Clin Neurol Neurosurg. 2021 Mar;202:106509. doi: 10.1016/j.clineuro.2021.106509. Epub 2021 Jan 22.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: August 10, 2025
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Spinal Cord Diseases; Spinal Cord Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Paralysis; Spinal Cord Neoplasms; Spinal Cord Compression
• Other Study ID Numbers: 2025SL079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No