Hip and Knee Patients Unknowingly Participate in Clinical Trials

Philadelphia, PAAlthough Larry had a hip replacement last year and Sherry had two knee replacements in 2007, they both have similarities: their hip and knee implants are metal-on-metal devices; both "baby boomers" are facing revision surgery; and they are both filing hip and knee replacement defective product claims against the manufacturers. And according to one medical device expert, they both unknowingly participated in medical device manufacturers' clinical trials.

According to Lana Keeton, patients with hip and knee replacements are, or have been, the clinical trials. "Instead of having thousands of injured patients out there, human clinical trials should have been completed prior to implanting any hip replacement into anyone."

Dr. Huddleston, an orthopedic surgeon at the Hip and Knee Institute, says as much regarding Johnson & Johnson's recently developed "cross-linked" polyethylenes. "It will take at least ten years of human usage before we will be sure that cross-linking is a true improvement," he is quoted as saying on the Institute's Web site.

Not only are hip and knee replacements loosening and causing patients severe pain and possibly replacement surgery; there are reports that metal-on-metal devices can release cobalt or chrome ions from the joint, and may cause blood poisoning and more. Regarding this issue, the Institute states: "If you are allergic to any metals you need to let Dr. Huddleston know." But you may not know you are allergic until you have a metal device implanted in your body! Again, patients may unwittingly be part of a clinical trial with this potentially life-threatening issue.

Back to Sherry, age 52. She has had "significant constant pain" in both knees and hasn't had a good night's sleep since her surgeries. "I cannot climb even a couple steps without a cane or hand rail because of the pain and weakness," she says. "I find it difficult to sit for any length of time in even the most comfortable of office chairs. I have no insurance or savings left after repeated unemployment over the past four years; I can't take a retail, sales or coffee shop job to help make ends meet because I cannot stand to be on my feet for hours at a time."

Larry, 55, has been told by his orthopedic surgeon that his hip replacement is loose and it has to be replaced. But he is reluctant to go through another painful surgery and four months of physical therapy. "I got this metal-on-metal hip because it was supposed to last longer than the others, and it was supposedly designed for "boomers" who are more active," he says. Larry is also worried that the loose implant could be releasing metal debris into his body. "I guess I have no choice," he says, "but this time I'm going to ask about a ceramic model, or something that has stood the test of time."

The FDA recently sent 145 orders to 21 medical device manufacturers requiring them to start post-market studies of hip implants. As of May 2011, these companies must give research protocol to the FDA that "addresses specific safety issues related to these devices. Data from the studies conducted will enable the agency to better understand these devices and their safety profiles." Meanwhile, manufacturers such as J&J are introducing new devices to the market, still without clinical trials.