Originally Posted by Win1894
(Post 2019760)
Sorry about the length. There is some good advice here and also some bad or misleading information that I would like to respond to having spent 40 years in the orthopedic business. I was mainly involved in a corporate R&D capacity for total hip and knee total joint devices, regularly testified to FDA panels regarding clearance of implant devices, worked with many prominent orthopedic surgeons developing state of the art implant procedures, and lastly consulted on many lawsuits against companies and surgeons regarding total joint arthroplasty failures.
Stem Cell therapies: May offer some relief on very early stages of osteoarthritis. I believe that only autogenous stem cell (harvested from the patient’s body) procedures don’t need FDA clearance, all other do and they should only follow a controlled FDA approved clinical study. If you are bone-on-bone (as determined by a simple AP x-ray), stem cell therapies will do nothing for you so don’t waste your money.
Side Approach: Over the years total joint surgical techniques have been successfully developed to reduce the amount of ancillary tissue damage (and trauma) incurred during the implantation procedure. This process has included the development of more refined instrumentation (by implant producers) available to the surgeon. Regarding total knee procedures the quadriceps muscle group were never severed. At most a ‘lateral release’ of the quads may have been performed in some more highly deformed patients’ knees in order to re-establish the proper biomechanics to the joint. Depending upon the level of knee deformity presented to the surgeon this may still be done in some instances. Mainly, it keeps the patella from dislocating laterally off the knee joint during ambulation. Anyway, over the years the surgical incision has been modified slightly to reduce ancillary tissue trauma. This results in less post surgical pain and therefore a faster recovery. Virtually all total knee systems today are placed using tissue sparing surgical approaches.
Post surgical rehab (PT): Do it, and don’t push the transition back into active sports or other highly physical activities. You will jeopardize the total joint arthroplasty. If the implants lose their fixation to the bone there is only one solution - surgical reconstruction. While the reduced pain may allow it the biology definitely favors a slow metered approach to pre-surgical activity levels. Slowly build up the musculature and other tissues spanning the operated joint. Bike riding, swimming, and walking are the best. Impact sports are never recommended by the folks that develop joint replacement devices. Every implant sold in the US comes with what is called a package insert. It contains all the contra-indications, precautions, and warnings for the device. Pre surgery have your doctor give you a copy and read it. Changing your lifestyle slightly away from competitive sports will enhance the longevity of your total joint arthroplasty. Also, to the best of your ability keep your weight down. Even small decreases in body weight reduce the stress on the total joint by a multiple of that decrease.
Painful Arthroplasty: Sometimes, even the best surgeons have patients who are subject to chronic joint pain. It’s less common than it used to be as surgical techniques and device designs have improved. Also, unfortunately, infections can occur following surgery but usually at a rate of less than 1%. They are difficult to treat and may require the removal of devices, treatment with an antibiotic laced spacer, and then total joint re-implantation after the infection has cleared.
Custom made devices: Unless you have a severe joint deformity the range of off-the-shelf sizes offered by manufacturers can successfully accommodate the vast majority of patients.
Lastly the comment by Wallflower (post #27): Utter nonsense. In the US all medical devices are cleared for sale by the FDA. This is a rigorous process of which I’ve been involved in many. There was never an easy path and all new devices including total joint devices must go through an FDA approved clinical study to prove safety and efficacy. Then the company request for marketing clearance to the FDA is scrutinized by FDA experts as well as FDA panel. The panel consists of independent (non FDA, non corporate) experts (Ph.Ds and MDs) in the field of the specialty such as orthopedics. For many devices the clinical study and clearance process may take many years. Additionally, device manufacturers are regularly visited by FDA field personnel. Their visit may take a week where they can go through all your manufacturing records and scrutinize all your quality processes to assure that you meet the myriad of requirements and standards for good manufacturing practices. If you don’t meet certain standards or are engaging in non approved practices they have the legal power to shut you down. Hope this helps. Good luck.
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