The document discusses the historical development of metallic biomaterials for orthopedic applications like hip replacements. It describes how early surgeon-scientists in the 19th century began systematically studying tissue-metal interactions and used available metallic materials to treat patients. This led to advances like cobalt-chromium alloys and paved the way for modern biomaterials pioneers like Charnley to develop successful prostheses. The field of biomaterials science emerged from this evolutionary process driven by the need to relieve pain and improve joint function.
Independent Solar-Powered Electric Vehicle Charging Station
Narayan Biomaterials.ppt
1. The Development of
Metallic Biomaterials
Roger J Narayan MD PhD
Associate Professor,
North Carolina State University and the
University of North Carolina
2. Abstract
• Man’s intrinsic desire to be active propelled the
development of biomaterials. Hip joint replacement surgery
is of the most revolutionary advances in modern
orthopaedic surgery, which both relieves pain and improves
function. The development of metallic biomaterials has
emerged as the result of a process of evolution in a
Darwinian manner. By the middle of the nineteenth century,
physicians began performing systematic studies in order to
better understand tissue-metal interaction. Unfortunately,
the development of metallic biomaterials was limited by a
lack of knowledge about durable and biocompatible
materials. This historical review illustrates how surgeon-
scientists who used off-the-shelf metallic biomaterials to
treat their patients. The modern field of biomaterials
science owes a great deal to these pioneering surgeons.
4. Common Reasons for Hip Replacement
Condition Incidence
• osteoarthritis 60 percent
• fracture-dislocations 11 percent
• rheumatoid arthritis 7 percent
• aseptic bone necrosis 7 percent
• revision of previous hip operations 6 percent
5. Bone replacement criteria include
the following:
• 1. Appropriate tissue-material interface
• 2. Non-toxic
• 3. Non-corrosive
• 4. Adequate fatigue life
• 5. Proper design
• 6. Proper density
• 7. Relatively inexpensive
• 8. Elastic and mechanical properties comparable to
those of bone
10. Hey-Groves examined use of metals to
immobilize fractures in a cat model
from page 4, Charles O. Bechtol, A. B.
Ferguson, and Patrick G. Laing, Metals and
Engineering in Bone and Joint Surgery,
Williams and Wilkins Company, Baltimore,
1959.
11. Sherman observed failure of metal plates
from page 5, Charles O. Bechtol, A. B.
Ferguson, and Patrick G. Laing, Metals and
Engineering in Bone and Joint Surgery,
Williams and Wilkins Company, Baltimore,
1959.
12. Zierold showed cobalt-chromium alloy
superior to high carbon steel
from page 8, Charles O. Bechtol, A. B.
Ferguson, and Patrick G. Laing, Metals and
Engineering in Bone and Joint Surgery,
Williams and Wilkins Company, Baltimore,
1959.
13. Mold arthroplasty using glass,
Viscaloid, Pyrex, Bakelite, and Vitallium
from page 201, P. G. Laing, Clinical Experience
with Prosthetic Materials: Historical
Perspectives, Current Problems, and Future
Directions, in Corrosion and Degradation of
Implant Materials ASTM STP 684, ASTM, West
Conshohocken, 1979.
14. Early Moore Prostheses
from page 14, Raymond G. Tronzo,
Surgery of the Hip Joint, Lea and
Febiger, Philadelphia, 1973.
19. Today, there are many new frontiers in
biomaterials engineering, including:
• 1. Porous Coatings
• 2. Bioactive Ceramics
• 3. Bulk Metallic Glasses
• 4. Tissue Engineering
20. Conclusions
• The development of metallic biomaterials has
emerged as the result of a process of evolution.
• By the middle of the nineteenth century,
physicians began performing systematic studies in
order to better understand tissue-metal
interaction.
• Surgeon-scientists originally used off-the-shelf
metallic biomaterials to treat their patients.
• The modern field of biomaterials science owes a
great deal to these pioneering surgeons.
Editor's Notes
The hip is the largest joint in the body. It is a ball-and-socket joint capable of various movements including abduction, adduction, extension, flexion, circumduction, and rotation.
Portions of the ilium, pubis, and ischium combine on the lateral surface of the hip bone (also known as the innominate bone) to form the acetabulum, or the horse-shoe shaped socket of the hip joint (from the Latin acetabulum, meaning “vinegar cup”). The acetabulum is further deepened by the fibrocartilaginous acetabular labrum, a rim of tissue extending from the acetabular margin. This socket articulates with the hemispherical head of the femur. The discontinuity in the non-articular inferior aspect of the bony rim of the joint socket (the acetabular notch) is bridged by the transverse acetabular ligament. The ligamentum teres extend from the notch to the fovea on the femoral head. The capsule consists of an external fibrous layer and an internal synovial layer. Itbcovers the ligamentum teres and a pad of fat contained in the acetabular fossa. Distally, capsular fibers and accompanying blood vessels extend to the femoral head and neck.
According the American Academy of Orthopaedic Surgeons, approximately 120,000 hip replacement operations are performed each year in the United States. The high frequency of hip joint replacements can be attributed to the fact that loss of function of the hip joint produces such a severely handicapping condition. Problems with hips are related to the demands on the joint brought about by an upright posture for which evolution has not kept pace. Loads on hip joints as high as 1400 lb must be carried without plastic deformation or fracture.
Prosthetic replacement of the hip is considered when the acetabulum or the head of the femur is damaged by degenerative or destructive conditions . These conditions include:
1. Osteoarthritis (also known as degenerative joint disease)
2. Rheumatoid arthritis and juvenile rheumatoid arthritis
3. Ankylosing spondylitis
4. Avascular necrosis
5. Salvage procedures
6. Persistent pain
Preserved skeletons show that osteoarthritis and rheumatoid disease have afflicted man since before recorded history. The use of materials as constituents of surgical implants is not new. Substitutions of bone parts for repairing seriously damaged portions of the human body have been recorded since the pre-Christian era. Bronze or copper were utilized in circumstances requiring the assembly of fractured bone parts. A major factor impeding success was the accumulation of toxic copper ions in the liver, brain, and other body tissues once the implant had completely dissolved. In the Inca civilization, some operations were carried out in which bone fragments removed during these operations were replaced in their original position. Unfortunately, substances suitable for implantations other than bronze or copper were not developed until the mid-eighteenth century. Thus, for most of human history, prostheses were external.
An early joint repair surgery credited to John Rhea Barton of of Lancaster, Pennsylvania. He hoped to make a stiff joint movable and painless via some type of surgical process. Unreported unsuccessful attempts probably had been made by his contemporaries. The patient was a sailor with a hip joint that was fused (ankylosed) in adduction, internal rotation, and flexion due to nonunion of fracture. Three months after the 1826 surgery, the patient walked with a cane and had functional mobility. The patient died of pulmonary tuberculosis ten years after the operation; however, he enjoyed a pain-free joint until his death.
Barton JR. On the treatment of ankylosis, by the formation of artificial joints. N. Amer. Med. Surg. J. 1827; 3:279-292.
Fortunately, the sailor had willed his body to Barton, thereby becoming both the world’s first implant donor. An autopsy examination revealed that the patient’s hip had returned to a fused position. Many arthroplasties were attempted shortly after this, but these usually resulted in disaster due to postoperative infection. In 1829, Levert made the first study of tissue tolerance to metal. After a series of experiments on dogs involving gold, silver, and lead, and platinum wires, he determined that platinum wire was the least irritating and best tolerated.
In the mid-nineteenth century, it was still believed that metal was one source of hospital gangrene. Lister's thesis “On the Antiseptic Principle in the Practice of Surgery” served as a landmark in the explosive development of surgery. Lister himself successfully sutured fractured patella bones with silver wire in 1885. Ten years later, Lane proved that the hazards originally associated with the use of metals could be reduced to a safe level when proper surgical technique was used. The “Lane technique” demonstrated aseptic precautions prevented infection during bone surgery.
Although Americans remained wary of metallic biomaterials, systematic biocompatibility testing were being performed in Europe. In 1913, Hey-Groves performed a thorough study of tissue tolerance to metals in peg, plate, and screw forms. He came to the following conclusions:
1. Nickel-plated steel has no irritating effect on the tissues.
2. Magnesium acts as a powerful stimulant to bone formation.
3. Aseptic materials are readily tolerated by the tissues.
Hey-Groves EW. An experimental study of the operative treatment of fractures. Brit. J. Surg. 1913; 438: 501.
Sherman (Allegheny Ludlum Steel Corporation, Pittsburgh) examined steel bone plates using a dog model. He found that the bone plates fractured at the junction of the central metal bar and the first screw hole. Sherman also noted that high carbon steels possessed good elastic properties but low ductility. He observed that ideal steel for a bone plate is “one that has a sufficient elastic limit with greatest ductility so that in case a strain should be exerted we would have a bending of the plate instead of a break. . .The addition of vanadium to a high carbon steel intensifies the hardening elements making the steel more dense and tough thereby increasing the elastic ratio; i.e., ratio between the elastic limit and elongation...lt would take great force to bend a vanadium plate sufficiently to break it.” Sherman also altered the plate design; for example, he patterned his plates after eye bars used in bridge construction, and reduced the number of screw eyes. Sherman’s design created a stronger plate that incidentally used less steel. His work put the internal fixation of bone fractures using metallic implants on a scientific basis.
Sherman WD. Vanadium steel plates and screws. Surg. Gync. & Obst. 1912; 14: 629.
Zierold studied the interaction between bone and various metals, including gold, silver, aluminum, zinc, lead, copper, nickel, high carbon steel, low carbon steel, stellite, copper, aluminum alloy, magnesium, and iron, in 1924. He used dogs as experimental animals in this work; he examined histological sections of bone as well as X-rays of implants in order to better understand implant-tissue interaction. Gold, silver, stellite, lead, and aluminum seemed to be well-tolerated; on the other hand, zinc, copper, nickel, high carbon steel, low carbon steel, aluminum alloy, magnesium, and iron appeared to interfere with bone repair. Stellite, a cobalt-chromium alloy, was shown to be the best-tolerated metal. Around that time, Venable and his co-workers performed biochemical analyses of tissues, which demonstrated that ion transfer between dissimilar implant metals did occur in accordance with electromotive force. Their studies demonstrated that cobalt-chromium alloy was “essentially nonelectrolytic.” Cobalt-chromium alloy was soon used in nails, cups, and other medical prostheses. The discovery of the first “ideal” orthopaedic alloy dramatically increased the use of metallic biomaterials.
Zierold A. Reaction of bone to various metals. Arch. Surg. 1924; 9: 365.
In 1923, Marius Smith-Petersen removed a piece of glass that had been imbedded in a man's scalp for one year and noticed the shiny nature of the residual space, which resembled a joint cavity. This surface looked like an appropriate surface for an artificial joint. He attempted to design a loose-fitting cup to be placed between the head of the femur and the acetabulum. The synthetic cup would mold the shape and the topology of regenerating cartilage. He first glass molds broke within several months or years after implantation. The broken molds were replaced by fresh molds. Then he turned to celluloid (Viscolloid), which produced an excessive tissue reaction. Pyrex, like glass, exhibited occasional breakage. In 1938, Smith-Petersen’s dentist, John Cooke, suggested that he turn to Vitallium. This material eventually became the material of choice in joint replacement.
Smith-Petersen MN. Evolution of mould arthroplasty of the hip joint. J. Bone Joint Surg. 1948; 13: 59-73.
The first report of a metallic replacement for the femur appeared in literature in 1942. In 1940, Bohlman and Moore removed a large malignant giant cell tumor from the upper end of the femur of a patient. They inserted a prosthesis to replace the whole upper third of the shaft of the femur. Bohlman soon followed the lead of Venable and Stuck and created implants using cobalt-chromium alloy.
Moore AT and Bohlman HR. Metal hip joint, a case report. J. Bone Joint Surg. 1943; 25: 688-692.
Venable CS, Stuck WG, Beach A. The effects on bone of the presence of metals; based upon electrolysis. An experimental study. Ann. Surg. 1937; 105: 917.
The acrylic femoral head implant developed in 1946 by Jean and Robert Judet of Paris. After the head and the neck of the femur were removed, the prosthesis was inserted through a hole in the remainder of the neck. The device consisted of a polymethylmethacrylate femoral head attached to a polymethylmethacrylate stem. The joint formed by this procedure was much more stable than that formed by the Smith-Petersen procedure, because the prosthesis had a closer fit with the surrounding anatomic structures. However, problems included squeaking, tissue reactivity with polymethylmethacrylate, loosening, wear, pain, and implant failure.
In the 1940’s, metallurgical researchers developed a low-cost method for purifying titanium. This metal and its high performance, high strength-to- weight ratio alpha-beta alloy (Ti-6wt%Al-4wt%V) was immediately pressed into medical use. In an early biocompatibility study, Bothe demonstrated a much more favorable histological response to titanium than to other materials. Jergesen examined screws and plates containing more than 99.6 per cent elemental titanium. There was no histological evidence of bone necrosis or delayed osteotomy healing vedwas obser in the experimental animals; however, approximately one-third of the tissues exhibited limited discoloration.
Judet, J., and Judet, R.: The use of an artificial femoral head for arthroplasty of the hip joint. J. Bone Joint Surg., 3213:166-173, 1950.
Bothe RT, Beaton LE, and Davenport HA. Reaction of Bone to Multiple Metallic Implants. 1940; 71: 598-602.
Jergensen FH. Studies of Various Factors Influencing Internal Fixation as a Method of Treatment of Fractures of the Long Bones. Report to National Research Council. Washington (DC), 1951.
The late Sir John Charnley lead three significant advances during the 1960’s that catapulted total hip replacement into the modern era of incredible progress:
1. the introduction of the metal-UHMWPE bearing couple
2. the use of methyl methacrylate for fixation
3. the reduction of postoperative sepsis due to the use of laminar flow and body exhaust systems, prophylactic antibiotics, and antibiotics placed in bone cement.
In the 1950’s, Charnley discovered that natural joints exhibit boundary lubrication. He then attempted to find a synthetic material with similarly low frictional properties. His first choice, polytetrafluoroethylene, exhibited very poor in vivo wear properties. Unfortunately, these issues only became evident after a large clinical trial involving polytetrafluoroethylene implants had begun. More than three hundred polytetrafluoroethylene implants had to be revised due to poor wear properties, necrosis, and implant loosening.
In 1962, a salesman from the German plastics manufacturer Ruhr Chemie brought polyethylene gears that were used in the nearby weaving factory to Charnley’s biomechanical laboratory. Charnley noted that: (a) polyethylene had good wear characteristics, and (b) polyethylene was capable of being lubricated by synovial fluid. The use of methylmethacrylate cement for attaching the implant to the surrounding bone and polyethylene revolutionized the practice of raised the success rate of joint replacement surgery to an exceptionally high level (>90%).
Charnley's total hip replacement is considered the gold standard for joint replacement; few changes have been made to prosthesis design in past forty years. This design employs a metal-on polyethylene combination to reduce friction and self-curing bone cement to provide fixation. However, the Charnley prosthesis does have several disadvantages. One was an unacceptable rate of wear (about 200 µm/year). Metallic and, more commonly, polymeric wear particles cause a severe foreign-body reaction in the tissues that surround the prosthesis.
