Evaluation of Vitoss With and Without BMA for Benign Cavitary Lesions

Bone Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02165943
• Other study ID #: 1101-0014
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 30, 2014
• Last updated: June 12, 2014
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: Orthovita d/b/a Stryker
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Bone Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Upstate Orthopedics, LLC	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Orthovita d/b/a Stryker

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Damron TA, Lisle J, Craig T, Wade M, Silbert W, Cohen H. Ultraporous ß-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. — View Citation

Eggli PS, Müller 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. — View 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. — View Citation

Itokazu M, Matsunaga T. Arthroscopic restoration of depressed tibial plateau fractures using bone and hydroxyapatite grafts. Arthroscopy. 1993;9(1):103-8. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No