Validation of Novel Predictive Score for Patients With Spinal Metastases

Completed

• Conditions: Spinal Metastases

• Registration Number: NCT03224650
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

The investigators are prospectively validating a prognostic clinical tool that uses a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict survival, post-treatment morbidity, and functional outcomes in patients with metastatic disease involving the spine.

Detailed Description

Recently, the investigators proposed a clinical prediction score that used a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin as a means to predict long-term survival following spine surgery for metastatic disease. This prognostic utility was developed using one-year mortality as the sole outcome measure. While the scoring system demonstrated many of the necessary attributes of a useful prediction tool, including simplicity, ease of use and clinical utility, it has yet to be validated prospectively and its capacity to predict other peri-operative outcomes, including physical and mental function following intervention, pain relief and the risk of complications, remain incompletely explored. To further evaluate the utility of this prognostic score, the investigators propose a series of three integrated experiments that will prospectively determine its capacity to accurately inform clinical decision making and recommendations for surgery for patients with metastatic spinal disease.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Primary Completion: 2020-07-13
• Study Completion: 2022-01-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

1. ≥ 18 years of age
2. Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum
3. Able to consent for themselves at the time of the intake evaluation
4. Speaks English

Exclusion Criteria

5. Primary bone tumors or leukemia
6. Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum
7. History of prior spine surgery for metastatic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	Up to 3 years	Mortality is documented using date of death in medical record
Short-Form (SF)-12	Up to 3 years	Assessment of state of health and physical/mental function
Visual Analog Scale (VAS) for pain	Up to 3 years	Assessment of current level of pain
EuroQuol 5-Dimension (EQ5D) profile	Up to 3 years	Assessment of state of health and physical/mental function
Patient-Reported Outcomes Measurement Information System (PROMIS)	Up to 3 years	Assessment of global health

Secondary Outcome Measures

Name	Time	Method
Post-treatment morbidity and readmissions	Up to 3 years	Post treatment complications and readmissions documented in medical record

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States