A Phase 1 interventional study of musculoskeletal complications management/prevention and bone graft in Adult Spinal Cord Neoplasm, Spinal Bone Metastases and Spinal Cord Compression, sponsored by University of Southern California. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2014-02-06.
Sponsored by University of Southern California · Phase 1, Interventional, and Supportive care
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.
105 studies on the registry are indexed under Spinal Cord Neoplasms; 27 are open to participants now.
This study's enrollment of 1 is below the median of 50 across 69 interventional studies indexed under Spinal Cord Neoplasms.
Browse Spinal Cord Neoplasms studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
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Exclusion Criteria:
Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.
Procedure: musculoskeletal complications management/prevention · Procedure: bone graft · Procedure: quality-of-life assessment · Other: questionnaire administration
Receive beta tricalcium-phosphate bone graft
Also known as: complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complications
Receive beta tricalcium-phosphate bone graft
Ancillary studies
Also known as: quality of life assessment
Ancillary studies
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.
Time frame: Within 12 months
Achievement of posterolateral fusion
Time frame: Up to 12 months
Occurrence of subsequent hardware failure
Time frame: Every 3 months for 12 months
Requirement of additional treatment is for instability
Time frame: Within 12 months
First documentation of posterolateral fusion
Time frame: 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
Time frame: Every 3 months for 12 months
The record gives a start of Jun 2011, a primary completion of Jul 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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