Clinical trial NCT02165943: Evaluation of Vitoss With and Without BMA for Benign Cavitary Lesions
Official title: A Combined Retrospective and Prospective Protocol to Evaluate Vitoss With and Without Bone Marrow Aspirate for Benign Cavitary Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Diseases
Lead sponsor: Orthovita d/b/a Stryker
Sponsor class: INDUSTRY
First posted: 2014-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from retrospective records from the investigators specialty practice.

Brief summary: This is a retrospective, two-arm study reviewing the healing of cavitary defects in patients treated with Vitoss alone versus those treated with Vitoss with bone marrow aspirate (BMA). There will be a prospective follow-up visit at 24+ months to evaluate lont-term healing in patients identified during the retrospective portion of the study. It is thought that the inclusion of BMA will facilitate the resorption of the graft material, leading to better long-term bone healing.


Eligibility criteria: Inclusion Criteria:

* males and females \>/= 18 years of age at the time of surgery
* 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:

* Patients with a known post-traumatic defect
* active infection at the time of implantation
* history of bone marrow disorders
* contraindications to the use of supplemental BMA

Primary outcomes:
measure: Percentage of Vitoss resorption into the native bone as observed via CT
timeFrame: minimum of 24 months post-operatively
Secondary outcomes:
measure: Presence of graft within the soft tissue as observed by CT
timeFrame: minimum of 24 months post-operatively
measure: Presence of a rim of radiolucency surrounding the grafted defect as observed by CT
timeFrame: minimum of 24 months post-operatively
measure: Size of the defect as observed by CT
timeFrame: minimum of 24 months post-operatively
measure: Bone trabeculation through the defect as observed by CT
timeFrame: minimum of 24 months post-operatively
measure: Persistence of graft material through the lesion as observed by CT
timeFrame: minimum of 24 months post-operatively
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Upstate Orthopedics, LLC
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Timothy Damron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.