Monday, May 7, 2012

Conventional Hip Replacement Alternative

Wright Conserve, a family of synthesized hip implants, was structured with metallic ball and cup bearings to employ a bone sparing technique. Wright Medical Technology Inc. is the manufacturer and distributor of the all-metal implant.  The BFH Technology, as named by Wright, is the type of technology these medical devices are currently utilizing.  BFH Technology or Big Femoral Head, mimics the femoral bone's dimensions in order to deliver better range of motion, and lessen the possibility of joint dislocation. Its metal to metal structure was devised for added durability to avoid premature implant wear.




The Wright Conserve series is composed of two hip resurfacing systems:

Conserve Partial Resurfacing Implant - this process, by the name itself, does not completely work on the entire hip bone but reuses the well-conditioned pelvic bone socket replacing only the femoral bone (the ball-shaped bone at the top of the thigh) with a metallic component of the same shape.

Conserve PLUS Total Resurfacing Implant - is composed of 2 metallic materials: a ball-shaped metal devised to mimic the femoral bone, and a metallic shallow cup that serves as a replacement to the damaged socket of the pelvic bone.

Although two components of this system possess a slight difference, they both work on achieving the same goal.  The Wright conserve system minimally invades a recipient's body by not replacing the hip bone albeit conserving it giving way to the reconstruction of its anatomical biomechanics providing improvement with stability, greater mobility, and reducing disability and trauma, as opposed to having the hip bone including its socket taken out and substituted with an implant that may be made separately of plastic, metal, and ceramic with traditional hip replacement.

Wright Conserve gained clearance to be made available to the market through the 510 (k) process, a pre-market notification process by the United States Food and Drug Administration.

An FDA device approval process, also referred to as the 510 (k) process, requires all Class III medical devices, and some Class I and II devices to submit a pre-market notification. The device is made eligible to enter the market once proven as "substantially equivalent" as safe and effective as another lawfully marketed device.

Wright Conserve was reportedly linked to a number of possible health problems despite being a good alternative to conventional hip replacement.

Recipients of the implant may be made vulnerable to the following serious health risks:

•    Femoral bone fracture
•    Femoral neck thinning
•    Heterotopic ossification - formation of an unnecessary bone around the hip leading to immobility
•    Avascular necrosis - deterioration of the bone due to lack of blood supply

URL References:

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/overview/default.htm
http://www.wmt.com/conserve/physicians/learnaboutconserve/default.asp
http://www.wmt.com/bigfemoralhead/physicians/advantages.asp
http://www.medicinenet.com/total_hip_replacement/article.htm