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

NCT07527728 | Not Yet Recruiting DMC

• 1 other identifier: 2025SL079
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metastatic Spinal Tumors; Spinal Cord Compression; Paralysis; Neurological Deficits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Sex of Participant

  preoperative

• Age of Participant

  preoperative

• ECOG Performance Status

  preoperative

• Time from Primary Cancer Diagnosis to Surgery

  preoperative

• Time from Spinal Metastasis Diagnosis to Surgery

  preoperative

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Related Publications (6)

• 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.

  PMID: 22000724 RESULT

• 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.

  PMID: 22327407 RESULT

• 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.

  PMID: 27752060 RESULT

• 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.

  PMID: 31256678 RESULT

• 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.

  RESULT

• 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.

  PMID: 33540174 RESULT

MeSH Terms

Conditions

Spinal Cord Neoplasms; Spinal Cord Compression; Paralysis

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wei Xu

CONTACT

+8613761278657; xuwei_spine@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share