CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest

Zimmer Biomet

Status: Completed

Conditions: Spinal Fusions

Study type: Observational

Funder types: Industry

Identifiers

NCT00768924

2006-012

Details and patient eligibility

About

The CopiOs Bone Void Filler (BVF) is a synthetic bone graft material consisting of calcium phosphate dehydrate within lyophilized type I bovine collagen that has been formed into pads of various sizes for surgical implantation. Pre-clinical animal studies suggest that the bone healing strength of CopiOs to be equivalent to autograft.

Full description

Purpose of the study is to evaluate the in-vivo use of CopiOs bone void filler in a single site trial, providing pre and post-operative evaluations of subjects undergoing spinal fusion with autogenous bone graft, in whom the CopiOs has been used as a bone void filler in the post-harvest iliac crest.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is 18 years and older
• Patient must be an appropriate candidate for iliac crest bone harvesting during a spinal fusion.
• Patient must be skeletally mature.
• Patient has signed an IRB approved Informed Consent and HIPAA compliant waiver.

Exclusion criteria

• Patient is suffering from any co-morbidities that would excessively increase the risk of surgery, including but not limited to pulmonary or cardiac conditions.
• Patient is pregnant.
• Patient has a severe degenerative bone disease.
• Patient has systemic conditions which would affect bone or wound healing.
• Patient is unwilling or unable to follow postoperative instructions or cooperate in a follow-up program.
• Patient is suffering from mental illness, alcohol abuse or drug abuse.
• Patient has known allergies to bovine collagen.
• Patient has a history of multiple allergies.
• Patient has infection at the surgical site.
• Significantly impaired vascularity proximal to surgical site.
• Sites are in direct contact with articular space.
• Sites where stresses on void will exceed the load strength of fixation hardware.
• Patient has hypercalcemia.

Trial design

35 participants in 1 patient group

1

Description:

Spinal fusion patients