Evaluation of Vitoss With and Without BMA for Benign Cavitary Lesions

NCT02165943 | Unknown

• 1 other identifier: 1101-0014
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Presence of graft within the soft tissue as observed by CT

  minimum of 24 months post-operatively

• Presence of a rim of radiolucency surrounding the grafted defect as observed by CT

  minimum of 24 months post-operatively

• Size of the defect as observed by CT

  minimum of 24 months post-operatively

• Bone trabeculation through the defect as observed by CT

  minimum of 24 months post-operatively

• Persistence of graft material through the lesion as observed by CT

  minimum of 24 months post-operatively

Study Arms (2)

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 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

Interventions

Vitoss DEVICE

Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.

Vitoss Bone Graft with BMA; Vitoss bone graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthovita d/b/a Stryker: lead

Study Sites (1)

Upstate Orthopedics, LLC

Syracuse, New York, 13210, United States

Location

Related Publications (6)

• 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.

  PMID: 2537166 BACKGROUND

• 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.

  PMID: 8775710 BACKGROUND

• 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.

  PMID: 8442816 BACKGROUND

• 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.

  PMID: 3074162 BACKGROUND

• 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.

  PMID: 23324964 BACKGROUND

• 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.

  PMID: 2838207 BACKGROUND

MeSH Terms

Conditions

Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Timothy Damron, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 18, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

US (1)