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

University of Southern California

Status and phase

Terminated

Phase 1

Conditions

Adult Spinal Cord Neoplasm

Spinal Bone Metastases

Spinal Cord Compression

Treatments

Procedure: bone graft

Other: questionnaire administration

Procedure: musculoskeletal complications management/prevention

Procedure: quality-of-life assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01407341

NCI-2011-01243 (Registry Identifier)

0S-09-12

Details and patient eligibility

About

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

Full 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.

Enrollment

1 patient

Sex

All

Volunteers

No Healthy Volunteers

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