Frequently Asked Questions 

 

Q: Why should I send my valuable implants to DARF? 

The DARF Center is an independent test laboratory with many clinical and university affiliations. Our mission statement focuses on the facts regarding clinical and retrieval phenomena and presenting that in independent and public forums. However, we are also heavily involved assisting industrial clients with projects run on a confidential, contractual basis. Therefore our expertise can be delivered on many fronts as required.

 

Q: What capabilities does DARF have? 

The DARF Center houses three suites designed for exploration of retrieved implants. These include state of the art analytical instruments; a) scanning electron microscope (Zeiss MA 15), b) Energy Dispersive Spectrometer for chemical analyses (Bruker EDS), c) 3-D contour measurement by CMM instrumentation (Mitotoyo, Legex 322) and surface roughness studies (Zygo; NewView 600 white light interferometer) and Martell software studies of implant wear on clinical radiographs. In addition the DARF Center works in close collaboration with the Peterson Tribology Laboratory located in the Dept. of Orthopedics at Loma Linda University, for hip and knee wear and debris studies. Additionally, the DARF Center has a worldwide network of laboratory contacts.

 

Q: What experience does DARF staff have? 

Directors of the DARF Center include Dr. Thomas K Donaldson and Dr Ian C Clarke. 

For over 40 years Dr Clarke has supervised hip and knee wear studies designed to assist the regulatory approval processes in various countries. Dr Clarke has held professorial appointments at UCLA, USC and currently at LLUMC (Loma Linda University Medical Center). His publication list includes many journal and chapter references on both clinical, biomechanical and biomaterials aspects of total joint replacements. Dr. Donaldson has been actively involved in hip and knee Arthroplasty since 1991. His passion for better serving his patient’s needs led to the partnership with Dr. Clarke and ultimately forming the Donaldson Arthritis Research Foundation. With over 10,000 joint replacements performed, Dr. Donaldson contributes to the continuing improvement of the surgical process. He routinely provides educational presentations to a worldwide audience.

 

Q: Has DARF presented or published any of these studies? 

DARF directors singularly and in collaboration with other professionals have published numerous studies over the years since founding DARF. Recently published studies include the following:

1. Donaldson, T., McPherson, E., Burgett, M., Clarke, I.C. MOM Failure Modes: An In-Depth Look at Metal Ions and Implant Wear. Reconstructive Review 2014; March: 33-37. 

2. Clarke, I.C., Lazennec, J.Y., Brusson, A., Savisaar, C., Bowsher, J.G., Burgett, M., Donaldson, T.K. Risk of Impingement and Third-body Abrasion With 28-mm Metal-on-metal Bearings. Clin Orthop Relat Res, 471 (2013). 

3. Clarke, I.C., Donaldson, T.K., Burgett, M., Smith, E.J., Bowsher, J.G., Savisaar, C., John, A., Lazennec, J.Y., McPherson, E., Peters, C.L. Normal and Adverse Wear Patterns Created In-vivo on MOM Surfaces - a retrieval study representing four vendors. M. Kurtz, S.A. Greenwald, W.M. Mihalko, J.A. Lemons (Eds.) ASTM Symposium on Metal-on-Metal Total Hip Replacement Devices, ASTM International, West Conshohocken, PA, 2013 pp. 157-192. 

 

Q: How much does premarket or postmarket retrieval testing cost? 

There is no charge for the initial receipt report. Charges for subsequent reports are based on the degree of detail and the tests required. Domestic and International collaborators receive special consideration. Please contact our staff at (909) 882-5867 ext. 122 or via email to c.brooks@darfcenter.org to discuss your special needs. We will work to accommodate you and your organization.

 

Q: What person do I call for lead-times and fees? 

Contact our staff at (909) 882-5867 ext. 122 or via email to c.brooks@darfcenter.org to discuss your special needs. We will work to accommodate you and your organization.

 

Q: How do I send the implant? 

Follow our instructions in the Implant Retrieval section of this web site. We recommend using a shipping service that will provide you with insurance, a shipping receipt, shipment tracking and a delivery receipt. In the USA, these services include FedEx and UPS. DHL transfers to the USPS for delivery upon entering the US and therefore we cannot recommend using them.

 

Q: Can I ship internationally to DARF? 

Yes. We recommend using a shipping service that will provide you with insurance, a shipping receipt, shipment tracking and a delivery receipt. These services include FedEx and UPS. DHL transfers packages to USPS upon entering the US and therefore we cannot recommend using them.

 

Q: Will there be a guarantee of chain of custody? 

Drs Clarke and Donaldson have many years experience in tracking implants and maintaining the chain of custody. Our staff is aware of the importance and trained to protect your valuable implant(s). Upon receipt we photograph the exterior of the package prior to opening. On opening, we photograph the interior of the package, and then inventory the contents. Photographic documentation accompanies all steps

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Q: Will there be a guarantee of non-destructive studies? 

All studies performed at the DARF Research Center are non-destructive.

 

Q: Will there be a guarantee of security/confidentiality? 

We comply with HIPAA. Our center is a secure facility with limited access to only those with direct need or purpose.

 

Q: What reports will I get back and when? 

We provide up to five levels of reporting as noted on the Reporting page.

 

Q: What format are the reports in? 

Each report is provided in a MS PowerPoint formatted document. Upon request we are able to convert the documents to PDF. A sample report is provided under Reporting.

 

Q: What type of payments are accepted? 

We accept payment in US dollars via PayPal, Visa, MasterCard or company check.