Evaluation of Vitoss With and Without BMA for Benign Cavitary Lesions
NCT ID: NCT02165943
Last Updated: 2014-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2014-01-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
Study Groups
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Vitoss Bone Graft with BMA
Patients with a benign bone lesion of the extremity or pelvis for which surgical curettage age was recommended and who received Vitoss bone graft with BMA to fill the cavity.
Vitoss
Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.
Vitoss bone graft
Patients with a benign bone lesion of the extremity or pelvis for which surgical curettage was recommended and who received Vitoss bone graft to fill the cavity.
Vitoss
Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.
Interventions
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Vitoss
Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.
Eligibility Criteria
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Inclusion Criteria
* Patients treated with Vitoss alone or Vitoss with added BMA between 2004 and 2012
* willing and able to provide Informed Consent to participate in and follow study requirements (including a radiologic assessment)
Exclusion Criteria
* active infection at the time of implantation
* history of bone marrow disorders
* contraindications to the use of supplemental BMA
18 Years
ALL
No
Sponsors
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Orthovita d/b/a Stryker
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy Damron, MD
Role: PRINCIPAL_INVESTIGATOR
State University of New York - Upstate Medical University
Locations
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Upstate Orthopedics, LLC
Syracuse, New York, United States
Countries
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References
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Bucholz RW, Carlton A, Holmes R. Interporous hydroxyapatite as a bone graft substitute in tibial plateau fractures. Clin Orthop Relat Res. 1989 Mar;(240):53-62.
Itokazu M, Matsunaga T, Ishii M, Kusakabe H, Wyni Y. Use of arthroscopy and interporous hydroxyapatite as a bone graft substitute in tibial plateau fractures. Arch Orthop Trauma Surg. 1996;115(1):45-8. doi: 10.1007/BF00453217.
Itokazu M, Matsunaga T. Arthroscopic restoration of depressed tibial plateau fractures using bone and hydroxyapatite grafts. Arthroscopy. 1993;9(1):103-8. doi: 10.1016/s0749-8063(05)80353-6.
McAndrew MP, Gorman PW, Lange TA. Tricalcium phosphate as a bone graft substitute in trauma: preliminary report. J Orthop Trauma. 1988;2(4):333-9. doi: 10.1097/00005131-198802040-00011.
Damron TA, Lisle J, Craig T, Wade M, Silbert W, Cohen H. Ultraporous beta-tricalcium phosphate alone or combined with bone marrow aspirate for benign cavitary lesions: comparison in a prospective randomized clinical trial. J Bone Joint Surg Am. 2013 Jan 16;95(2):158-66. doi: 10.2106/JBJS.K.00181.
Eggli PS, Muller W, Schenk RK. Porous hydroxyapatite and tricalcium phosphate cylinders with two different pore size ranges implanted in the cancellous bone of rabbits. A comparative histomorphometric and histologic study of bony ingrowth and implant substitution. Clin Orthop Relat Res. 1988 Jul;(232):127-38.
Other Identifiers
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1101-0014
Identifier Type: -
Identifier Source: org_study_id
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