Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01243 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Lack of funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (ChronOS) | Experimental | Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| musculoskeletal complications management/prevention | Procedure | Receive beta tricalcium-phosphate bone graft |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Chen | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033-0804 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| bone graft | Procedure | Receive beta tricalcium-phosphate bone graft |
|
| quality-of-life assessment | Procedure | Ancillary studies |
|
|
| questionnaire administration | Other | Ancillary studies |
|
| 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 |
| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| D013117 | Spinal Cord Compression |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013119 | Spinal Cord Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |
Not provided
Not provided