Pro Osteon Bone Void Filler Study | NCT00858598

Studies
Pro Osteon Bone Void Filler Study

NCT00858598

Sponsor

Zimmer Biomet

Status

Withdrawn

Last Update Posted

Jun 21, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Osteoarthritis
Revision Arthroplasty

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never started. Study suspended indefinitely.

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jul 2013Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Mar 9, 2009

First Submission Date that Met QC Criteria

Mar 9, 2009

First Posted Date

Mar 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2017

Last Update Posted Date

Jun 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was designed to observe the outcomes of Pro Osteon according to its cleared indications for use.

Detailed Description

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of Pro Osteon® as a Bone Void Filler. FDA has cleared this device via premarket notifications 510(k) K063346, K980817, and K990131. There will be no experimental or investigational devices used.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Pro Osteon		All patients in this pilot study will receive pro osteon as a bone void filler and will be enrolled according to the same inclusion / exclusion criteria.

Measure	Description	Time Frame
Radiographic Evaluation		3 Years

Measure	Description	Time Frame
Knee Society Score		3 Years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion criteria will be the same as the stated indications stated in the summary of the FDA approved 510(k) K063346, K980817, and K990131 application. These indications are stated below:

PRO OSTEON® 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
PRO OSTEON® 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e, the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PRO OSTEON® 500R can be combined with autogenous blood, and/or sterile fluids (saline or Ringer's solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Surgical techniques and patient care are to be standard for the surgeon participating in the protocol and should be maintained the same throughout the course of the data-collection.
All patients must sign an IRB-approved Informed Consent to be enrolled into the study.

Exclusion Criteria:

Exclusion criteria will be the same as the stated contraindications stated in the summary of the FDA approved 510(k) K063346, K980817, and K990131 application. These contraindications are stated below:

Pro Osteon® 500R Resorbable Bone Graft Substitute is contraindicated for fractures of the growth plate
For segmental defects
For indications which may be subjected to excessive impact or stresses
When there is significant vascular impairment proximal to the graft site
When there are metabolic or systemic bone disorders that affect bone or wound healing
In infected sites
When stabilization of the defect is not possible.
The use of Pro Osteon® 500R is also contraindicated in cases where intraoperative soft tissue coverage is not planned or possible.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who fit within the inclusion / exclusion criteria of the FDA cleared indications for use.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17403800	Background	Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
7890786	Background	Harris AI, Poddar S, Gitelis S, Sheinkop MB, Rosenberg AG. Arthroplasty with a composite of an allograft and a prosthesis for knees with severe deficiency of bone. J Bone Joint Surg Am. 1995 Mar;77(3):373-86. doi: 10.2106/00004623-199503000-00007.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases