Pro Osteon Pilot Study - Full Text View

Sponsored by:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00858598

Purpose

This study was designed to observe the benefits of Pro Osteon when used in Tibial voids (areas where the bone has not grown beneath the knee). Many patients lose part of their tibia (beneath the knee) when they need to receive a knee revision surgery. This study will observe if there is potential benefit to filling that void with Pro Osteon.

Condition
Osteoarthritis Revision Arthroplasty

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Pro Osteon Tibial Void Filler Pilot Study

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Radiographic healing - obliteration of interfacial line between bone/implant [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Turnover rate (20%, 40%, etc) Secondary Endpoints Knee Society Score UCLA Activity Score [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	May 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Pro Osteon All patients in this pilot study will receive pro osteon as a tibial void filler and will be enrolled according to the same inclusion / exclusion criteria.

Detailed Description:

The number of revision knee surgeries is expected to rise significantly in the coming decades1. A major complication of revision surgery is the loss of bone stock that results from the removal of old components or as a corollary to the process that has created the need for the revision (i.e. infection, osteolysis, loosening). The loss of bone stock is handled primarily by filling the space with PMMA bone cement. Other options include the use of morselized or bulk bone graft or metallic bulk augments2.

Bone cement, sometimes augmented with bone screws, has been shown to be successful. However, the bone cement cannot be resorbed and would need to be removed in the case of a future revision. Autograft or allograft can be resorbed and may lead to a restoration of bone stock. However, graft materials can be difficult and expensive to procure and, in the case of allografts, come with some risk of disease transmission3. Metallic bulk augments provide structural integrity to the host bone and are readily available. However, like bone cement, these void fillers cannot be remodeled into bone. While it is expected that porous metal augments will provide excellent stability due to their porous nature, revision could be extremely difficult due to the same porosity. Pro Osteon® void fillers ("Pro Osteon® ") have the advantage of being readily available and resorbable. Pro Osteon® has been used extensively in spinal reconstructions and to a lesser extent in the morselized form in total joint arthroplasty4. It is expected that the material will behave in a similar manner as when used in other sites, but the performance of bulk Pro Osteon® in total knee revision arthroplasty is unknown. It will be important to quantify important characteristics such as remodeling time.

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of Pro Osteon® as a Tibial 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who fit within the inclusion / exclusion criteria, and need a tibial knee revision.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858598

Contacts

Contact: Megan A Lawson, BGS	574-371-1183	megan.lawson@biomet.com
Contact: Ken Beres, MD	1-800-348-9500 ext 1691	ken.beres@biomet.com

Sponsors and Collaborators

Biomet, Inc.

More Information

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.

Responsible Party:	Biomet Manufacturing, Inc ( Ken Beres, MD )
Study ID Numbers:	US 6
Study First Received:	March 9, 2009
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00858598 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Total Knee Arthroplasty
Revision
Tibial
Void
Bone Filler

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 06, 2009