Pro Osteon Bone Void Filler Study

Osteoarthritis Clinical Trial

— PO  

Official title:

Pro Osteon Bone Void Filler Data Collection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00858598
• Other study ID #: US 6
• Status: Withdrawn
• Phase: N/A
• First received: March 9, 2009
• Last updated: June 19, 2017
• Start date: December 2009
• Est. completion date: January 2014

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Revision Arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

References & Publications (6)

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. — View Citation

Chapman MW: Bone grafting. Chapman MW, Madison M (eds.): Operative Orthopaedics. Philadelphia, JB Lippincott, 1993, pp 139-49

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. — View Citation

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. — View Citation

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. — View Citation

Lewonowski K, Dorr LD. Revision of cementless total knee arthroplasty with massive osteolytic lesions. J Arthroplasty. 1994 Dec;9(6):661-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Evaluation		3 Years
Secondary	Knee Society Score		3 Years