Pro Osteon Bone Void Filler Study
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Revision Arthroplasty
Phase: N/A
Status: Not yet recruiting
Sponsored by: Biomet, Inc. Overall contact:
Megan A Lawson, BGS, Phone: 574-371-1183, Email: megan.lawson@biomet.com
Summary
This study was designed to observe the outcomes of Pro Osteon according to its cleared
indications for use.
Clinical Details
Official title: Pro Osteon Bone Void Filler Data Collection
Study design: Cohort, Prospective
Primary outcome: Radiographic Evaluation
Secondary outcome: Knee Society Score
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Megan A Lawson, BGS, Phone: 574-371-1183, Email: megan.lawson@biomet.com Additional Information
Related publications: 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. 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. Chapman MW: Bone grafting. Chapman MW, Madison M (eds.): Operative Orthopaedics. Philadelphia, JB Lippincott, 1993, pp 139-49 Lewonowski K, Dorr LD. Revision of cementless total knee arthroplasty with massive osteolytic lesions. J Arthroplasty. 1994 Dec;9(6):661-3. No abstract available. Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4. Amstutz HC, Thomas BJ, Jinnah R, Kim W, Grogan T, Yale C. Treatment of primary osteoarthritis of the hip. A comparison of total joint and surface replacement arthroplasty. J Bone Joint Surg Am. 1984 Feb;66(2):228-41.
Starting date: December 2009
Ending date: January 2014
Last updated: September 25, 2009
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