A Study Comparing Surgical Methods in Patients with Cancer Spread to the Spine — Which is Better: Short Segment or Multilevel Fixation?

Efficacy and Safety of Short Segment Fixation Compared to Traditional Multilevel Fixation for Metastatic Spinal Tumors: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010476

Enrollment

Registered

2025-05-20

Start date

2025-06-02

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : This study compares two posterior spinal fixation methods in patients with metastatic spinal tumors, focusing on differences in the extent of fixation. All participants will underg

the only difference lies in the extent of pedicle screw fixation. Intervention group (Short Segment Fixation): Pedicle screws are inserted into the vertebrae one level above and below the affected seg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults aged 19 years or older Diagnosed with metastatic spinal tumor and meeting at least one of the following surgical indications: a. Spinal Instability Neoplastic Score (SINS) = 7 b. Presence of neurological symptoms (e.g., motor weakness, sensory deficits, or bladder/bowel dysfunction) Estimated life expectancy of 3 months or more Anatomical conditions allowing the application of both short segment and multilevel fixation Willing and able to comply with follow-up visits and study procedures Has provided written informed consent after receiving a full explanation of the study

Exclusion criteria

Exclusion criteria: Aged 18 years or younger, or 90 years or older Deemed medically unfit for spinal surgery under general anesthesia due to conditions such as heart failure, poor pulmonary function, liver cirrhosis (Child C), or end-stage renal disease on dialysis Extensive spinal involvement across multiple levels that makes short segment fixation structurally inappropriate Advanced cancer with poor expected recovery or life expectancy less than 3 months Impaired consciousness, cognitive dysfunction, or psychiatric illness that interferes with participation or follow-up Determined by the investigator to be unsuitable for study participation for any other reason

Design outcomes

Primary

Measure	Time frame
Incidence of instrumentation-related complications within 12 months after surgery	—

Secondary

Measure	Time frame
Changes in pain level (Visual Analogue Scale, VAS);Changes in functional status (ECOG performance status, Karnofsky Performance Score);Changes in quality of life (Spine Oncology Study Group Outcome Questionnaire, SOSGOQ);Reoperation rate and instrumentation revision/removal rate;Surgical factors: length of hospital stay, operation time, and estimated blood loss;Fusion status of instrumented segments (radiographic evaluation)	—

Measure

Time frame

Changes in pain level (Visual Analogue Scale, VAS);Changes in functional status (ECOG performance status, Karnofsky Performance Score);Changes in quality of life (Spine Oncology Study Group Outcome Questionnaire, SOSGOQ);Reoperation rate and instrumentation revision/removal rate;Surgical factors: length of hospital stay, operation time, and estimated blood loss;Fusion status of instrumented segments (radiographic evaluation)

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Countries

Korea, Republic of

Contacts

Public ContactDanbi Park

Asan Medical Center

danbi08@kakao.com+82-2-2045-3829

Outcome results