Evaluation of Vitoss With and Without BMA for Benign Cavitary Lesions

A Combined Retrospective and Prospective Protocol to Evaluate Vitoss With and Without Bone Marrow Aspirate for Benign Cavitary Lesions

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.

Study Overview

• Status: Unknown
• Conditions: Bone Diseases
• Intervention / Treatment: Device: Vitoss

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • Upstate Orthopedics, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from retrospective records from the investigators specialty practice.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.	Device: Vitoss; Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Vitoss resorption into the native bone as observed via CT	Percentage of Vitoss resorption into the native bone will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.	minimum of 24 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of graft within the soft tissue as observed by CT	Presence of the graft within the soft tissue will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.	minimum of 24 months post-operatively
Presence of a rim of radiolucency surrounding the grafted defect as observed by CT	Presence of a rim of radiolucency surrounding the grafted defect will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.	minimum of 24 months post-operatively
Size of the defect as observed by CT	The size of the defect will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.	minimum of 24 months post-operatively
Bone trabeculation through the defect as observed by CT	Bone trabeculation through the defect will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.	minimum of 24 months post-operatively
Persistence of graft material through the lesion as observed by CT	Persistence of graft material through the lesion will be retrospectively recorded in the Case Report Form at the 6 week, 3, 6, 12 and 18 month timepoints based on review of x-rays as well.	minimum of 24 months post-operatively

Collaborators and Investigators

• Sponsor: Orthovita d/b/a Stryker

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: May 30, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (ESTIMATE): June 18, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 12, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases
• Other Study ID Numbers: 1101-0014