The growing American Joint Replacement Registry now contains 19,000 Procedures

Registry has data on 19,000 TJA procedures and plans for more growth (AAOS)     Momentum is building,” said David G. Lewallen, MD, chair of the American Joint Replacement Registry (AJRR) board of directors, during an AJRR informational session at the 2012 AAOS Annual Meeting. “Multiple entities have committed to the effort.” Reflecting on “lessons learned,” Dr. Lewallen [...]

HSS releases archive of Failed Joint Replacements providing tips for better Hip Replacement outcomes

  Archive of Failed Joint Replacements Provides Tips to Building a Better Hip Replacement (press release) A study by Hospital for Special Surgery researchers has provided the first comprehensive look at just how metal-on-metal total hip replacements are failing in patients around the country. Made possible by what is thought to be the largest archive of failed joint [...]

Stryker Biotech Has Dodged all OP-1 Prosecutions Except One – Mark Phillips, the former president

   Stryker Pays $15M Fine in a DOJ Settlement After Unapproved OP-1 Clinical Study OP-1 Prosecutions Down To One (Walter Eisner @ OTW) The Boston Globe reported on January 20 that prosecutors dropped felony conspiracy and fraud charges against two remaining Stryker Biotech OP-1 sales reps on trial in Boston. Judge George O’Toole, Jr. of the [...]

FDA issues guidance on IDEs for knee cartilage repair/replacement

          FDA issues guidance on IDEs for knee cartilage repair/replacement devices and drugs (MassDevice) The FDA issues new guidance on proper submissions for investigational device exemption and investigational new drug applications for products intended to repair or replace knee cartilage. The FDA this week issued new guidance on getting clearance for clinical trials of [...]

Stryker pays $15M fine in a DOJ Settlement after Unapproved OP-1 Clinical Study

         Stryker Reaches Settlement with the U.S. Attorney’s Office (press release) Kalamazoo, Michigan – January 18, 2012 – Stryker Corporation (NYSE:SYK) announced today that Stryker Biotech has reached a settlement with the U.S. Attorney’s Office for the District of Massachusetts.  As part of the settlement, Stryker has agreed to plead to one misdemeanor [...]

Knee Replacement Surgery Incidence Soars In Those Over Age 50

  Knee Replacement Surgery Incidence Soars In Those Over Age 50 (Medical News Today) Researchers in Finland found that annual cumulative incidences of partial and total knee arthroplasty, commonly known as knee replacement surgery, rose rapidly over a 27-year period among 30 to 59 year-olds in that country, with the greatest increase occurring in patients aged [...]

Old Implants Have Edge On New Implants

      Old Implants Have Edge On New (Biloine Young @ OTW) It is back to the drawing board for new hip and knee prosthesis. Reason? A five-year Australian study has found that the newer hip and knee replacement joints are performing no better—and sometimes worse—than the older, less expensive devices. The study concluded that [...]

Cemented polished stems preserve femur in young patients receiving THA

     Cemented polished stems preserve femur in young patients receiving THA (OrthoSuperSite) The use of cemented polished stems may help preserve the femur in young patients undergoing total hip arthroplasty, according to Australian researchers. Bogdan Solomon, MD, presented his team’s findings at the SICOT XXV Triennial World Congress 2011, in Prague. “Total hip replacement performed in young patients has [...]

Senators Ask Medtronic about their Post-Market Device Tracking regarding Infuse

        Senators press Medtronic for device info (Star Tribune) WASHINGTON – Three U.S. senators have asked Fridley-based Medtronic Inc. to supply detailed information about how the company keeps track of its medical devices after they go to market. In a six-page letter that strikes an investigational tone, Sens. Charles Grassley, R-Iowa, Herb Kohl, [...]

4 Former Synthes Executives Sentenced to Prison Time for Unapproved Bone Cement study

        Sentencing… Michael Huggins (ex-COO @ Synthes) 9 months jail time currently under appeal Thomas Higgins (ex-Sr VP @ Synthes) 9 months jail time Richard Bohner (ex-VP @ Synthes) 8 months jail time John Walsh (ex-Director Clin/Reg @ Synthes)  5 months jail time Ex-Synthes Exec Bohner Sentenced To 8 Months In Prison In Bone-Cement Case (WSJ [...]

Medtronic Infuse Woes Prompt Subpoena from California Attorney General

          Medtronic Infuse Woes Prompt Subpoena from California Attorney General (NewsInferno) Medtronic, Inc. has disclosed that the California Attorney General issued a subpoena to the company in October as part of an investigation into its Infuse bone graft product. In its latest 10-Q filing, Medtronic said it was fully cooperating with the California probe, [...]

Nationwide Study to Determine if Spinal Discs can be Regenerated with a Stem Cell Injection

         Definitive Back-Pain Study? (Biloine Young @ OTW) Can a single injection of stem cells repair and regenerate diseased lumbar discs? That question may soon be answered by the first of its kind nationwide study that will test the safety and efficacy of the use of mesenchymal precursor cells (MPCs) to replace bone, [...]

Research in Orthopedics: Managing Conflicts of Interest to Maintain Objectivity and Integrity of Results

      Research in Orthopedics: Managing Conflicts of Interest to Maintain Objectivity and Integrity of Results (Laura Miller @ Beckers) Chapters are: Introduction Recognizing conflicts of interest What orthopedic research stands to lose Why research is important Maintaining integrity in the peer-review process Read entire article at Beckers

Yale Review of Infuse Study to Begin – “Does Infuse work? and Is Infuse safe?”

           Did Medtronic Sell and Unsafe Product? (Star Tribune – Business) Krumholz Begins Infuse Study  (Bilione Young @ OTW) A doctor who Forbes Magazine called “the most powerful doctor you never heard of” is the one hired by Medtronic, Inc. to evaluate and render a verdict on its product Infuse. In their examination and study [...]

Large diameter metal-on-metal hip replacements yield high failure rate, corrosion

          Large diameter metal-on-metal hip replacements yield high failure rate, corrosion (OrthoSuperSite) One recent investigation from U.K. researchers has found an “unacceptable” high rate of failure among large diameter, hybrid metal-on-metal hip replacements studied, according to results presented at the British Orthopaedic Association and Irish Orthopaedic Association Combined Meeting 2011 in Dublin. According to study author Ben JRF [...]

Did Medtronic sell an unsafe product?

           Did Medtronic sell an unsafe product? (Star Tribune – Business) Under fire, the company looks to a top researcher to answer questions about its big seller Infuse. For Dr. Harlan Krumholz, numbers tell stories. The pioneering Yale University cardiologist’s medical sleuthing — called “outcomes research” — involves studying how sick people [...]

Million-dollar payments to Orthopedic surgeons raise questions

    Study evaluates industry payments to orthopedic surgeons (press release) Million-dollar payments to surgeons raise questions (Reuters Health) Orthopedic surgeons have received hundreds of millions of dollars from joint implant manufacturers in recent years, according to a report released Monday. In 2007, five device makers said they had paid surgeons more than $198 million, with 43 [...]

3 US multi-center stem cell trials are underway – injecting cells into the disc, the annulus and the fractured vertebra

     Spine Stem Cell Trials Underway (written by Bilioine Young @ OTW) Dr. Hyun Bae, co-director of the spine fellowship program at Cedars-Sinai Spine Center, Los Angeles, was among the first surgeons to use growth factor tissue engineering for intervertebral discs and multilevel artificial disc replacements for both the lumbar and cervical spine. Now he [...]

Expanding Orthopedics initiates study to measure Pedicle Screw performance in Germany

  Pedicle Screw Study Launched (written by Biloine Young @ OTW) Expanding Orthopedics Inc. (EOI), based in Israel, has launched a post-market study in Europe of its XPED Expanding Pedicle Screw System for spinal fusion. Up to 50 patients will be enrolled in the multi-center study which will be led by the spine team of [...]

Study: Patients with pain after Total Knee Replacement are more likely to have a poor outcomes

      Pain After TKR Ominous Sign (written by Biloine Young @ OTW) Experiencing pain before knee replacement surgery can be a trial, but being in pain following the surgery can be a disaster. Dr. Jeffrey N. Katz, professor of medicine and orthopedic surgery at Harvard Medical School, has found that patients who experience severe [...]

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