Validation of Novel Predictive Score for Patients With Spinal Metastases

Mass General Brigham

Status: Completed

Conditions: Spinal Metastases

Study type: Observational

Funder types: Other

Identifiers

NCT03224650

2017P000203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

219 participants in 3 patient groups

Surgical

Description:

Patients treated surgically for spinal metastases

Non-operative

Description:

Patients treated non-operatively for spinal metastases

Expectant

Description:

Patients receiving no treatment for spinal metastases