Pro Osteon Bone Void Filler Study

NCT00858598 | Withdrawn

• 1 other identifier: US 6
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoarthritis; Revision Arthroplasty

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Radiographic Evaluation

  3 Years

Secondary Outcomes (1)

• Knee Society Score

  3 Years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Related Publications (6)

• 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.

  PMID: 17403800 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.

  PMID: 7890786 BACKGROUND

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

  BACKGROUND

• Lewonowski K, Dorr LD. Revision of cementless total knee arthroplasty with massive osteolytic lesions. J Arthroplasty. 1994 Dec;9(6):661-3. doi: 10.1016/0883-5403(94)90121-x. No abstract available.

  PMID: 7699380 BACKGROUND

• 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.

  PMID: 2805470 BACKGROUND

• 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.

  PMID: 6693450 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: December 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: June 21, 2017

Record last verified: 2017-06