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Pro Osteon Bone Void Filler Study

Pro Osteon Bone Void Filler Data Collection

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00858598
Acronym
PO
Enrollment
0
Registered
2009-03-10
Start date
2009-12-31
Completion date
2014-01-31
Last updated
2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Revision Arthroplasty

Keywords

Total Knee Arthroplasty, Revision, Tibial, Void, Bone Filler

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.

Interventions

None listed

Sponsors

Zimmer Biomet
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Radiographic Evaluation3 Years

Secondary

MeasureTime frame
Knee Society Score3 Years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026