Hip Resurfacing News

Waqqy is a 17 year old teenager who needed a hip resurfacing. He went to Mr. McMinn of the UK and due to bone problems, he had 2 surgeries and ended up with a MOM THR. He has put together a great video talking about hip resurfacing and his THR.

 

Click on the arrow to start the video

 

Operation Vacation -Big Savings Have More Overseas Travelers Mixing Surgery With Sightseeing

 

By Cindy Loose Washington Post Staff Writer Sunday, September 9, 2007

 

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On learning he needed heart surgery last spring, Larry Shaw's first question was: How much?

 

The surgeon's fee, between $1,500 and $2,000, was within Shaw's means as a self-insured businessman. But the angioplasty, including placement of a thin tube in a clogged artery, would require a one-night hospital stay. He called the closest major medical center to his Dallas home. Estimated charge: $47,000, not including anesthesia.

 

Shaw's next calls were to Thailand and India.

 

The price at Bangkok's private Bumrungrad International Hospital: $6,400, including a two-night stay, surgeon's fees, anesthesiologist and drugs. The Apollo hospital in New Delhi: $4,600.

 

A few weeks later, in late June, Shaw and his wife, Kathy, are more than 9,000 miles from home, walking the marble floors of a Bangkok hospital lobby that looks like the entrance to a newly renovated Hilton. Shaw, by economic necessity, is joining an ever-growing trend: medical travel, sometimes referred to as medical tourism.

 

The reputation of outstanding U.S. hospitals has long drawn wealthy patients from around the world. But today, traffic also heads in the opposite direction. It's a trend that quietly has been expanding well beyond facelifts, tummy tucks and dental crowns to embrace all sorts of non-emergency treatments.

 

Most American patients are seeking significantly lower prices. But some go abroad for treatments not yet available or not yet widely practiced in the United States. Others head overseas for the personalized service emphasized by high-end private hospitals working to appeal to an international clientele.

 

"There is a fierce, pitched battle for medical tourists, who are the highest-value tourists in terms of how long they stay and money spent," says Ruben Toral, marketing director of Bumrungrad Hospital. "Governments in Southeast Asia and now in Dubai view it as an important extension of regular tourism."

 

Medical travelers logged an estimated 19 million trips and spent $20 billion in 2005; the numbers are expected to more than double by 2010, according to Tourism Research and Marketing, a London consulting firm. Thailand last year served 1.4 million medical tourists, including 65,000 Americans, some of whom were already living abroad. Singapore and India also have a strong network of hospitals drawing foreign tourists, as does Malaysia.

 

Other parts of Asia rushing to develop medical tourism: South Korea, Taiwan and the Philippines. Brazil, Costa Rica and Mexico also attract Americans seeking cosmetic surgery or dentistry, but "the infrastructure isn't in place for extensive, invasive procedures," says Josef Woodman, author of a how-to guide called "Patients Beyond Borders: Everybody's Guide to Affordable, World-Class Medical Tourism."

 

A medical tourist, as opposed to a medical traveler, will use some of his or her savings on medical care to enjoy a holiday abroad. Take Dana Updyke, 62, of Los Angeles, who was recently on a ferry between Phuket and the Phi Phi Islands. She had come to Thailand several weeks earlier for a hip resurfacing, a less-invasive alternative to a hip replacement that is not yet widely practiced in the United States. After recuperating in a five-star hotel on the beach, a stone's throw from a satellite hospital Bumrungrad operates in Phuket, she was ready to move from one Thai tourist destination to an even more exotic one.

 

Some international hospitals broker deals with resorts. The Apollo Chennai in India, for example, staffs the ritzy Taj Fisherman's Cove on the Bay of Bengal with an intern and nurses prepared to do routine follow-up care.

 

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Study: Surface replacement arthroplasty may offer advantages over THA

Canadian investigators said hip resurfacing resulted in greater patient activity after 2 years.

By Robert Trace
1st on the web (September 19, 2007)
September 2007

SEOUL — Total hip arthroplasty is an established procedure with well-documented complication rates and clinical results, but surface replacement arthroplasty may offer additional clinical benefits to many patients, according to a group of Canadian researchers.

"We decided in 2003 to do a comparative study of hip resurfacing, or surface replacement arthroplasty (SRA), to the gold standard of total hip arthroplasty (THA), since we were not aware of any direct prospective studies out there comparing the two procedures," said Pascal-André Venditolli, MD, of the Maisonneuve-Rosemont Hospital in Quebec.

He and his colleagues randomly assigned 210 hips to receive uncemented metal-on-metal THA (103 hips) or a hybrid metal-on-metal SRA (107 hips). All surgeries were performed by three orthopedic surgeons, who used a posterior approach.

The researchers prospectively collected perioperative and postoperative data, and analyzed the clinical data for a minimum of 2 years.

Postop complications included three isolated traumatic dislocations and one recurrent dislocation in the THA group, which required acetabular cup revision. Two SRAs required revision for late head collapse. No postop femoral neck fractures occurred in the SRA group, he said.

There was one case of loosening at 6 months postop in the resurfacing group, which had shifted varus. There were also two cases of deep venous thrombosis in both patient groups, he said.

Although the investigators did not report a significant difference in surgical time between the two procedures, patients' length of stay in the hospital was significantly shorter for the SRA group compared to the THA patients — 5 days vs. 6.1 days for the THA group (P=.001).

"There was also a significant difference in return to work: 96% of the SRA patients returned to their previous work within 1 year vs. 83% in the THA group," Venditolli said.

Although patients in both groups demonstrated a high satisfaction rate and achieved similar WOMAC and Merle d'Aubigné functional scores, "SRA patients had better UCLA activity scores (7.1 vs. 6.3; P=.037) and returned to heavier activities (P=.035)" after 2 years, he said.

"This randomized study shows that SRA and THA present a similar complication rate, but distinctive complications," Venditolli said. "It also suggests that SRA results in better function and improved patient activity in comparison to THA.

"However, the effect of long-term fixation related to increased activity levels is unknown. Long-term follow-up is necessary to determine the survivorship of SRA over THA," he said.

For more information:

Vendittoli P-A, Lavigne M, Lusignan D, Roy A-G. A randomized study comparing surface replacement arthroplasty to total hip arthroplasty: 2-4 years follow-up. F028-2. Presented at the 15th Triennial Congress of the Asia Pacific Orthopaedic Association. Sept. 9-13, 2007. Seoul.

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Comparative Arthroplasty Alternatives for the Young Arthritic
By Thomas P. Schmalzried, MD
ORTHOPEDICS 2007; 30:756
September 2007

Thomas P. Schmalzried

Hip resurfacing is embraced by patients. In principle, the attraction is similar to smaller incisions: patient satisfaction is related to the degree of invasion of their body.

Hip resurfacing is driven by the Internet, with an Internet pro-resurfacing culture perceiving total hip replacement (THR) as an older technology and an older person’s operation. This perspective is fueled by the historical risk of dislocation, traditional activity restrictions, and concerns of component loosening with bone loss leading to morbid revision THR. There is a paucity of patient awareness regarding the outcomes of current-generation THR. In fact, there is a paucity of studies comparing current-generation THR and total resurfacing.

Indications for Total Hip Resurfacing
Total resurfacing and THR are not directly competing technologies. The indications for hip resurfacing are more limited. Not all patients who are candidates for THR are good candidates for resurfacing .

Categorically, total hip resurfacing should be considered for those patients at increased risk for failure of THR. Historically, such patients are young and healthy, with men being at greater risk than women. Patients who have been told they are too young for THR have embraced resurfacing. The operative parameters for conversion of a failed resurfacing to THR are similar to those for a primary THR.(1)

With current technology, the acetabular component size and position are essentially the same for total resurfacing and THR.2 The issues are on the femoral side and include:

Bone Density. The risk of femoral neck fracture following resurfacing is related to bone density, with an increased risk in women and men >65 years.3,4
Head-to-Neck Ratio. Because resurfacing occurs around the femoral neck, it is technically helpful to have a head-to-neck ratio >1.2.
Femoral Offset and Limb Length. With resurfacing, femoral offset and limb length cannot be changed to a practically significant degree; therefore, these parameters should be close to normal (>120° neck-shaft angle and limb-length difference within 1 cm).2
Focal Defects. Because focal defects undermine support for the component, large necrotic segments or cystic defects are undesirable.5
Hips that have all 4 of these criteria are arthritic hip grade (AHG) A, which is basically a normal hip with no cartilage. Grade B hips lack 1 factor, grade C hips lack 2 factors, and grade D hips lack 3 factors.6

Clinical Results

In our series of more than 350 consecutive total hip resurfacings(7),  there have been no femoral neck fractures. After a 2-year minimum follow-up, AHG was significantly associated with preoperative Harris Hip score (A>B>C), occurrence of mild to moderate postoperative pain (A<B & C), and hip range of motion. In other words, hips with a lesser degree of secondary arthritic changes had a higher AHG and a better outcome. The mean UCLA activity score was 8.2, but activity scores were higher for higher hip grades. These data support the selection criteria and also support relatively early intervention.

During the same period, we compared our first 50 consecutive hip resurfacings in 50 patients to 44 THRs performed in 35 patients.7 Surgeries were performed by the same surgeon using a posterior approach. The same postoperative protocol was followed in both groups with no activity restrictions; minimum follow-up was 2 years.

As one might expect, there were differences between the two groups. Average age was 46 years for resurfacing patients versus 55 years for THR patients. Resurfacing patients were predominantly men and taller, and had a lower body mass index.

Resurfacing patients had a lower preoperative Harris Hip score (ie, reported more pain), but they had a higher preoperative UCLA activity score and greater preoperative range of motion. The resurfacing patients had a lower mean ASA score (ie, better general health).

On average, it took 18% longer to perform the surface replacements than the THRs. However, total blood loss was 250 cc lower with the resurfacings (despite a larger exposure), probably because there was no femoral canal violation or bleeding. Less transfusions were given in the resurfacing group because of the lower blood loss and the better general health status of the patients. There was no significant difference in the length of hospital stay between the two groups.(7)

With regard to outcomes, hip resurfacing patients had the same 2-year Harris Hip score (97 versus 96). Hip resurfacing patients had greater functional improvement, resulting in a greater increase in the Harris Hip score. The resurfacing patients also had a greater increase in UCLA activity score and a higher postoperative SF-12 physical score. There was no difference between the groups in postoperative range of motion. In fact, the THR group had greater improvement. There was one dislocation in each group.

The bottom line is both technologies performed very well in our series. Because patient characteristics are the main determinant of outcome, we must be careful with simple technology-based comparisons.(7)

References 1. Ball ST, Le Duff MJ, Amstutz HC. Early results of conversion of a failed femoral component in hip resurfacing arthroplasty. J Bone Joint Surg Am. 2007; 89:735-741.
2. Silva M, Lee KH, Heisel C, Dela Rosa MA, Schmalzried TP. The biomechanical results of total hip resurfacing arthroplasty. J Bone Joint Surg Am. 2004; 86:40-46.
3. Shimmin AJ, Back D. Femoral neck fractures following Birmingham hip resurfacing: a national review of 50 cases. J Bone Joint Surg Br. 2005; 87:463-464.
4. Australian Orthopaedic Association National Joint Replacement Registry 2006. Available at: www.dmac.adelaide.edu.au/aoanjrr/ .
5. Amstutz HC, Beaule PE, Dorey FJ, Le Duff MJ, Campbell PA, Gruen TA. Metal-on-metal hybrid surface arthroplasty: two to six-year follow-up study. J Bone Joint Surg Am. 2004; 86:28-39. 7. Fowble VA, dela Rosa MA, Schmalzried TP. A comparison of total hip resurfacing and total hip replacement patients and outcomes. Clin Orthop Relat Res. In press.

Correspondence should be addressed to: Thomas P. Schmalzried, MD, Joint Replacement Institute at St Vincent Medical Center, S. Mark Taper Bldg, 2200 W Third St, Ste 120, Los Angeles, CA 90057.

Comparative Arthroplasty Alternatives for the Young Arthritic READ COMPLETE ARTICLE

 

Estimates of Healthcare-Associated Infections

CDC strives to understand how healthcare-associated infections happen and to develop appropriate interventions. A new report from CDC updates previous estimates of healthcare-associated infections. In American hospitals alone, healthcare-associated infections account for an estimated 1.7 million infections and 99,000 associated deaths each year. Of these infections:

• 32 percent of all healthcare-associated infection are urinary tract infections
• 22 percent are surgical site infections
• 15 percent are pneumonia (lung infections)
• 14 percent are bloodstream infections

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Osteonecrosis Of The Femur - Hip Resurfacing Surgery, Alternatives to Hip Replacement
By Alampallam Venkatachalam

 

Osteonecrosis is a condition due arising from a diminution of blood supply to bone. It affects most importantly the upper end of the femur. If left untreated it progresses to bony collapse and arthritis. The causes are many like alcohol abuse, steroid intake, Caisson's disease, Gaucher's disease.

 

The patient can experience sudden pain in the hips which radiates to the knee and can be confused for knee pain. Gait is painful. In early cases, x- rays are negative and MR scans are diagnostic. Treatment in the early stages is controversial and there are no clear guidelines.

 

Prolonged bed rest and crutch walking have not been shown to relieve pain or halt progression of the disease.

 

Treatment in late cases

 

Core decompression does ameliorate symptoms. It is minimally invasive and does not involve a replacement. If it fails then a replacement is possible at a later date.

 

Treatment in late cases with advanced destruction

 

Treatment is by a total hip replacement if bony destruction is extensive. A partial or total surface hip replacement is done if destruction is confined to the surface cartilage alone. Since it occurs in young individuals, a Surface Hip replacement is a better option as it conserves bony stock and a total hip replacement can still be done at a later date. Resurfacing of the hip is restricted to those cases of osteo necrosis where the amount of destruction is less than 30 percent of the head. Where it exceeds thirty percent, a new type of hip prosthesis called the Proxima hip is available in Chennai. This Proxima hip is an uncemented metal on metal large diameter bearing. It has been performed for avascular necrosis and other conditions like ankylosing spondylitis, post traumatic arthritis following acetabular fracture. Vascularised fiblar graft is done with the help of a microvascular surgeon.

 

The author trained with eminent Hip experts in Cambridge, Manchester and Livepool. He performs Hip replacements, Hip resurfacing, Proxima hip replacements, Osteotomies, Fracture fixation, Core decompression, Birmingham replacements at Bharathiraja hospital. Visit http://www.hipsurgery.in and http://www.kneeindia.com Contact him at 00 91 9282165002

 

Article Source: http://EzineArticles.com/?expert=Alampallam_Venkatachalam
http://EzineArticles.com/?Osteonecrosis-Of-The-Femur---Hip-Resurfacing-Surgery,-Alternatives-to-Hip-Replacement&id=185317

2007-09-19 22:47:00

Nanotechnology diamond ice coatings could improve knee prostheses and solar cells

There is a huge demand for medical implants for almost every body part you can think of. As we have reported here before, the market for medical implant devices in the U.S. alone is estimated to be $23 billion per year and it is expected to grow by about 10% annually for the next few years. Implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, tissue and spinal orthopedic implants, hip replacements, phakic intraocular lenses and cosmetic implants will be among the top sellers. Current medical implants, such as orthopedic implants and heart valves, are made of titanium and stainless steel alloys, primarily because they are biocompatible. Unfortunately, in many cases these metal alloys with a life span of 10-15 years may wear out within the lifetime of the patient. With recent advances in industrial synthesis of diamond and diamond-like carbon film bringing prices down significantly, researchers are increasingly experimenting with diamond coatings for medical implants. On the upside, the wear resistance of diamond is dramatically superior to titanium and stainless steel. On the downside, because it attracts coagulating proteins, its blood clotting response is slightly worse than these materials and the possibility has been raised that nanostructured surface features of diamond might abrade tissue. That's not something you necessarily want to have in your artificial knee or hip joints (although some of the currently used implant materials cause problems as well). Researchers have now run simulations that show that thin layers of ice could persist on specially treated diamond coatings at temperatures well above body temperature. The soft and hydrophilic ice multilayers might enable diamond-coated medical devices that reduce abrasion and are highly resistant to protein absorption.

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Study: Surface replacement arthroplasty may offer advantages over THA

Canadian investigators said hip resurfacing resulted in greater patient activity after 2 years.

By Robert Trace
1st on the web (September 19, 2007)
September 2007

SEOUL — Total hip arthroplasty is an established procedure with well-documented complication rates and clinical results, but surface replacement arthroplasty may offer additional clinical benefits to many patients, according to a group of Canadian researchers.

"We decided in 2003 to do a comparative study of hip resurfacing, or surface replacement arthroplasty (SRA), to the gold standard of total hip arthroplasty (THA), since we were not aware of any direct prospective studies out there comparing the two procedures," said Pascal-André Venditolli, MD, of the Maisonneuve-Rosemont Hospital in Quebec.

He and his colleagues randomly assigned 210 hips to receive uncemented metal-on-metal THA (103 hips) or a hybrid metal-on-metal SRA (107 hips). All surgeries were performed by three orthopedic surgeons, who used a posterior approach.

The researchers prospectively collected perioperative and postoperative data, and analyzed the clinical data for a minimum of 2 years.

Postop complications included three isolated traumatic dislocations and one recurrent dislocation in the THA group, which required acetabular cup revision. Two SRAs required revision for late head collapse. No postop femoral neck fractures occurred in the SRA group, he said.

There was one case of loosening at 6 months postop in the resurfacing group, which had shifted varus. There were also two cases of deep venous thrombosis in both patient groups, he said.

Although the investigators did not report a significant difference in surgical time between the two procedures, patients' length of stay in the hospital was significantly shorter for the SRA group compared to the THA patients — 5 days vs. 6.1 days for the THA group (P=.001).

"There was also a significant difference in return to work: 96% of the SRA patients returned to their previous work within 1 year vs. 83% in the THA group," Venditolli said.

Although patients in both groups demonstrated a high satisfaction rate and achieved similar WOMAC and Merle d'Aubigné functional scores, "SRA patients had better UCLA activity scores (7.1 vs. 6.3; P=.037) and returned to heavier activities (P=.035)" after 2 years, he said.

"This randomized study shows that SRA and THA present a similar complication rate, but distinctive complications," Venditolli said. "It also suggests that SRA results in better function and improved patient activity in comparison to THA.

"However, the effect of long-term fixation related to increased activity levels is unknown. Long-term follow-up is necessary to determine the survivorship of SRA over THA," he said.

For more information:

Vendittoli P-A, Lavigne M, Lusignan D, Roy A-G. A randomized study comparing surface replacement arthroplasty to total hip arthroplasty: 2-4 years follow-up. F028-2. Presented at the 15th Triennial Congress of the Asia Pacific Orthopaedic Association. Sept. 9-13, 2007. Seoul.

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Metal-metal Hip Resurfacing Offers Advantages Over Traditional Arthroplasty in Selected Patients

By Robert L. Barrack, MD
ORTHOPEDICS 2007; 30:725
September 2007

Total hip arthroplasty (THA) is among the most successful interventions in medicine. It is the best option for most patients with end-stage arthritis of the hip. However, THA has some limitations, and problems with THA are far from nonexistent. Revisions account for almost 20% of hip cases in the United States, and this number is growing.1 These revision cases pose a greater risk for patients.

Avoiding the need for revision would be a substantial benefit, and diminishing the morbidity should revision become necessary would be equally important. Potential problems also exist in performing a THA in many young, active patients, and hip resurfacing offers advantages in many of these areas.

Indications and Advantages of Hip Resurfacing
Managing Femoral Deformity and Suboptimal Anatomy

An uncommon, but useful indication for hip resurfacing is for patients with proximal femoral deformity, in whom a total hip can be difficult if not impossible (Figure 1). More commonly, suboptimal anatomy is an issue, as with patients in whom even the smallest stem requires reaming, which puts patients at long-term risk for stem fracture (Figure 2). Conversely, a large canal presents problems for implanting a cementless stem (Figure 3).


Avoiding Stress Shielding

The presence of a femoral stem inevitably causes some degree of thigh pain, which is more common with larger stems.2 Stress shielding occurs over time from nonphysiologic hoop stresses. The long-term sequelae include bone loss, thigh pain, and stem fracture. The only hip arthroplasty associated with maintaining or increasing bone density is metal-metal hip resurfacing.3

Preventing Limb-length Difference and Dislocation

The major long-term complications of THA leading to more morbidity, dissatisfaction, and lawsuits are limb lengthening and dislocation. With hip resurfacing, the incidence of dislocations is markedly less than with THA. In the Medicare database, 4% of THA patients experience a dislocation in the first 6 months following surgery.4

Retaining Bone Stock for Future Revisions

Another major advantage of hip resurfacing is retaining bone stock for future revisions. Conversion to a THA is more similar to a primary than a revision procedure in terms of operative time, blood loss, and clinical success.5

Enabling Patients’ Return to a High Activity Level

The most compelling argument in favor of hip resurfacing is activity level. The fastest growing segment of the THA marketplace is patients <55 years. These patients want to maintain an active lifestyle, and they shun limitations.

In a study completed this year, a survey of the leading hip surgeons in the United States was performed regarding what activities they recommend to their patients. Activities prohibited by approximately 80%, even with the new bearing surfaces or large metal heads, included virtually every activity that required any impact.6

In contrast, surgeons generally do not limit activities after hip resurfacing. In a recently published study, following hip resurfacing, 92% of patients participated in sports, and none gave up their preferred sport.7 This high level of activity apparently does not compromise the clinical result. In a study of 446 hips in patients <55 years who were given no activity restrictions, 90% of patients returned to sports, and there was only 1 revision in 2 to 8 years of follow-up.8

We are now dealing with a new generation of hip patients. They are more informed and involved, educated, and active. The concepts of maintaining bone and less activity restriction resonate with them. They know others who have had hip replacement, and they have researched all of the available data on hip replacement, including the data on new bearing options. A high percentage of these patients have rejected THA and prefer the resurfacing concept.

Conclusion
Resurfacing is not for every patient or for every surgeon. However, it offers substantial advantages in properly selected patients. Because of this, metal-metal hip resurfacing has become the fastest growing arthroplasty procedure in the world in recent years outside the United States. With the US Food and Drug Administration granting approval in 2006 for one component, and approval for a second component pending, this trend will continue for the foreseeable future.

References

Zhan C, Kaczmarek R, Loyo-Berrios N, Sangl J, Bright RA. Incidence and short-term outcomes of primary and revision hip replacement in the United States. J Bone Joint Surg Am. 2007; 89:526-533.
Vresilovic EJ, Hozack WJ, Rothman RH. Incidence of thigh pain after uncemented total hip arthroplasty as a function of femoral stem size. J Arthroplasty. 1996; 11:304-311.
Kishida Y, Sugano N, Nishii T, Miki H, Yamaguchi K, Yoshikawa H. Preservation of the bone mineral density of the femur after surface replacement of the hip. J Bone Joint Surg Br. 2004; 86:185-189.
Phillips CB, Barrett JA, Losina E, et al. Incidence rates of dislocation, pulmonary embolism, and deep infection during the first six months after elective total hip replacement. J Bone Joint Surg Am. 2003; 85:20-26.
Ball ST, Le Duff MJ, Amstutz HC. Early results of conversion of a failed femoral component in hip resurfacing arthroplasty. J Bone Joint Surg Am. 2007; 89:735-741.
Klein GR, Levine BR, Hozack WJ, et al. Return to athletic activity after total hip arthroplasty. Consensus guidelines based on a survey of the Hip Society and American Association of Hip and Knee Surgeons. J Arthroplasty. 2007; 22:171-175.
Narvani AA, Tsiridis E, Nwaboku HC, Bajekal RA. Sporting activity following Birmingham hip resurfacing. Int J Sports Med. 2006; 27:505-507.
Daniel J, Pynsent PB, McMinn DJ. Metal-on-metal resurfacing of the hip in patients under the age of 55 years with osteoarthritis. J Bone Joint Surg Br. 2004; 86:177-184.
Author
Dr Barrack is from the Department of Orthopedic Surgery, Washington University School of Medicine, Barnes-Jewish Hospital, St Louis, Mo.

“Orthopaedic Crossfire” is a registered trademark of A. Seth Greenwald, DPhil(Oxon).

Correspondence should be addressed to: Robert L Barrack, MD, Dept of Orthopedic Surgery, Washington University School of Medicine, One Barnes-Jewish Hospital Plaza, 11300 W Pavilion, St Louis, MO 63110.

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Study results outline dabigatran etexilate as potential thromboprophylaxis therapy for patients undergoing total hip replacement surgery

 

RIDGEFIELD, Conn., Sept. 13 /PRNewswire/ -- Boehringer Ingelheim today announced that the September 15 issue of The Lancet will publish results from the RE-NOVATE study, which investigated dabigatran etexilate as a potential therapy for patients undergoing total hip replacement surgery(1). The results from this study demonstrate that both doses (220mg and 150mg) of the oral direct thrombin inhibitor, dabigatran etexilate, administered for a median of 33 days, were non-inferior to injectable enoxaparin in reducing the risk of venous thromboembolism (VTE) after total hip replacement surgery with similar safety.

 

The primary endpoint of this trial was a composite consisting of total venous thromboembolic events and all-cause mortality during treatment, which occurred in 6.0% of the 220mg group and 8.6% of the 150mg group taking dabigatran etexilate, versus 6.7% of the enoxaparin group. Importantly, a pre-specified secondary outcome of major venous thromboembolism and venous thromboembolism-related mortality was also similar between groups, occurring in 3.1% of the 220mg group and 4.3% of the 150mg group taking dabigatran etexilate, versus 3.9% of the enoxaparin group.

 

Anticoagulation-related bleeding is the primary safety concern during hip replacement surgery, since major bleeding into the replaced joint can have a detrimental impact on clinical outcome(2). Generally, few major bleeding events were reported, occurring at 2.0% in the 220mg group and 1.3% in the 150mg group for dabigatran etexilate, versus 1.6% in the enoxaparin group. Notably about half of all major bleeding events started after surgery and before the first dose of dabigatran etexilate. There were no major bleeding events reported after hospital discharge in the dabigatran etexilate groups.

 

Data from frequent liver function monitoring showed that the frequency of increases in liver enzyme concentrations with dabigatran etexilate is low during the entire extended treatment period. Results showed that alanine aminotransferase (ALT) elevation greater than three times the upper limit of normal occurred in 5.3% enoxaparin group, as compared to 3.0% in the 150mg group and 3.0% in the 220mg group taking dabigatran etexilate. Similarly, the incidence of acute coronary events was low, with no significant differences between all groups.

 

Current treatment guidelines recommend that patients undergoing knee or hip replacement surgery receive thromboprophylaxis (treatment to prevent VTE) with low molecular weight heparin (LMWH), fondaparinux or warfarin for at least 10 days after surgery. For patients undergoing hip replacement surgery, extended thromboprophylaxis for up to 28-35 days is recommended.(3) The RE- NOVATE study was designed consistent with these guidelines.

 

About dabigatran etexilate

 

Dabigatran etexilate is an investigational oral direct thrombin inhibitor that specifically and reversibly inhibits thrombin, the key enzyme for blood clot formation, and is currently in phase 3 development. In the RE-NOVATE study, dabigatran etexilate was dosed once a day without routine coagulation monitoring. Patients in the study received a fixed dose of dabigatran etexilate and were not titrated during the duration of the study.

 

Further studies investigating dabigatran etexilate

 

Dabigatran etexilate is being investigated in multiple phase 3 trials that are designed to investigate the oral direct thrombin inhibitor as a potential treatment and prophylaxis for several thromboembolic disease conditions. The phase 3 clinical trial program is expected to involve more than 27,000 patients from Asia, Australia, Europe, the Americas, and South Africa.

 

Boehringer Ingelheim Pharmaceuticals, Inc.

 

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

 

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and approximately 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

 

In 2006, Boehringer Ingelheim posted net sales of US $13.3 billion (10.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development. For more information, please visit http://us.boehringer-ingelheim.com.

 

References
1. Lancet ref
2. Lotke PA, Lonner JH. Deep venous thrombosis prophylaxis: better living through chemistry-in opposition. J Arthroplasty 2005;20:15-7
3. Geerts WH, Pineo GF, Heit JA et al. Prevention of Venous Thromboembolism: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126:338-400

Web site: http://us.boehringer-ingelheim.com/

 

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