Validation of Novel Predictive Score for Patients With Spinal Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical

Patients treated surgically for spinal metastases

No interventions assigned to this group

Non-operative

Patients treated non-operatively for spinal metastases

No interventions assigned to this group

Expectant

Patients receiving no treatment for spinal metastases

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No