Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Compression
Conditions
Brief summary
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
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.
Interventions
Receive beta tricalcium-phosphate bone graft
PROCEDUREbone graft
Receive beta tricalcium-phosphate bone graft
PROCEDUREquality-of-life assessment
Ancillary studies
OTHERquestionnaire administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of durable posterolateral fusion | Within 12 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Requirement of additional treatment is for instability | Within 12 months |
| Achievement of posterolateral fusion | Up to 12 months |
| Occurrence of subsequent hardware failure | Every 3 months for 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 |
Countries
United States
Outcome results
None listed