Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer
This study has been terminated.
(Lack of funding)
Sponsor:
USC/Norris Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01407341
First received: July 29, 2011
Last updated: August 10, 2012
Last verified: August 2012
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Purpose
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
| Condition | Intervention |
|---|---|
|
Adult Spinal Cord Neoplasm Spinal Bone Metastases Spinal Cord Compression |
Procedure: musculoskeletal complications management/prevention Procedure: bone graft Procedure: quality-of-life assessment Other: questionnaire administration |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | ChronOS Stability Study: For Metastatic Cancer |
Resource links provided by NLM:
Further study details as provided by USC/Norris Comprehensive Cancer Center:
Primary Outcome Measures:
- Achievement of durable posterolateral fusion [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]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 Outcome Measures:
- Achievement of posterolateral fusion [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Occurrence of subsequent hardware failure [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
- Requirement of additional treatment is for instability [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
- First documentation of posterolateral fusion [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
- Occurrence of pain or disability experienced after surgery that is related to spinal metastasis or is a consequence of the resulting treatment [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 1 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Supportive care (ChronOS)
Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.
|
Procedure: musculoskeletal complications management/prevention
Receive beta tricalcium-phosphate bone graft
Other Names:
Procedure: bone graft
Receive beta tricalcium-phosphate bone graft
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407341
Locations
| United States, California | |
| University of Southern California | |
| Los Angeles, California, United States, 90033-0804 | |
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
Investigators
| Principal Investigator: | Thomas Chen | University of Southern California |
More Information
No publications provided
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01407341 History of Changes |
| Other Study ID Numbers: | 0S-09-12, NCI-2011-01243 |
| Study First Received: | July 29, 2011 |
| Last Updated: | August 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms Neoplasm Metastasis Spinal Cord Compression Spinal Cord Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Pathologic Processes Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Spinal Cord Injuries Wounds and Injuries Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Bone Diseases Musculoskeletal Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013