Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer

Study Overview
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Brief Summary
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This pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone growth in patients undergoing surgery for spine cancer

Detailed Description
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OBJECTIVES: I. To determine if Chronos (beta-tricalcium phosphate bone graft) will form a posterolateral fusion mass in patients undergoing fusion surgery for spine cancer within 12 months. II. To evaluate quality of life following the use of ChronOS as measured by (a) pain (or lack of pain) associated with pseudoarthrosis and (b) the need for additional treatment for instability as a result of hardware failure. OUTLINE: Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. After completion of study treatment, patients are followed up at 1 month and then every 3 months for 1 year.

Official Title
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ChronOS Stability Study: For Metastatic Cancer

Conditions
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Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Compression

Intervention / Treatment
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* Procedure: musculoskeletal complications management/prevention
* Procedure: bone graft
* Procedure: quality-of-life assessment
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing surgery for spinal decompression for tatic spine cancer who require bone substitute for a posterolateral spinal fusion Patients may or may not have posterolateral instrumentation Exclusion Criteria: Status-post previous fusion with allogeneic bone graft
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (ChronOS)<br>Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. | Procedure: musculoskeletal complications management/prevention<br>* Receive beta tricalcium-phosphate bone graft<br>* Other names: management/prevention, musculoskeletal complications;Procedure: bone graft<br>* Receive beta tricalcium-phosphate bone graft<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of durable posterolateral fusion | Measured from x-ray and/or computed tomography (CT) scans. Standard criteria of determining fusion is visualization of continuous trabeculating bone bridging the transverse processes and facets on AP and lateral x-rays or when there is < 2 degree angular motion and < 2mm of translation on standing flexion and extension radiographs. | Within 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of posterolateral fusion |  | Up to 12 months | 
| Occurrence of subsequent hardware failure |  | Every 3 months for 12 months | 
| Requirement of additional treatment is for instability |  | Within 12 months | 
| First documentation of posterolateral fusion |  | Within 12 months | 
| Occurrence of pain or disability experienced after surgery that is related to spinal metastasis or is a consequence of the resulting treatment |  | Every 3 months for 12 months |