Abstract：
:The current study reviews the early history of surgeon-initiated trial and error development in hip joint arthroplasty and the subsequent methodological evolution to proper criteria for hypothesis testing using bioengineers and other research scientists. The interplay and relationships to industry, universities, scientific organizations, and the Food and Drug Administration with respect to device development in hip arthroplasty are reviewed. The ethics of and responsibilities to involved parties are outlined, citing the history of many contemporary developments. Examples are provided from the evolution and introduction of unsuccessful innovations, and the problems inherent in the current methodology of the approval process from the Food and Drug Administration using the 5-10K, Investigative Device Exemption, and the Pre-Market Approval protocols. The pros and cons of randomized trials for devices are outlined with the conclusion that they are not appropriate for device introduction. The proper, rational methodology for introduction of new devices is a phased-in clinical trial process after pertinent bench testing. Finally, the ethical dilemmas created by managed care are addressed. Industry involvements of the surgeon-spokesmen are cited.
journal_name
Clin Orthop Relat Resjournal_title
Clinical orthopaedics and related researchauthors
Amstutz HCsubject
Has Abstractpub_date
2000-09-01 00:00:00pages
23-30issue
378eissn
0009-921Xissn
1528-1132pub_type
杂志文章abstract：:Fractures of the femur in two women, ages 17 and 27, were treated with Brooker-Wills nails. While the distal deployment device was inserted into the nail in one patient, the tip of the driver/inserter broke into the proximal end of the distal deployment device. This complicated the extraction of the nail and the dista...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1993-05-01 00:00:00
abstract：BACKGROUND:Rotator cuff repair is a successful treatment in terms of patient satisfaction and pain relief regardless of the repair method. Although arthroscopic repair is commonly thought to be less painful than open or miniopen repair, studies disagree on this point. QUESTIONS/PURPOSES:We wished to compare the result...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：10.1007/s11999-014-3715-6
更新日期：2014-09-01 00:00:00
abstract：:The factors which determine the rate and amount of acetabular growth in congenital dislocation of the hip are ill-understood. A prospective radiological study has been devised in order to assess the influence of the age of congruity, femoral anteversion and neck/shaft angles on acetabular growth. To be included, the c...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1976-09-01 00:00:00
abstract：:The unstable intertrochanteric/subtrochanteric fracture, as identified by the modified Müller classification, should be considered a separate entity with its own problems. It can be highly unstable; none of the orthopedic appliances has been designed with this fracture in mind. Compression screws yield better results ...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1990-03-01 00:00:00
abstract：:To understand the mechanism of injury and classify fractures of the talus requires knowledge of the anatomy of the hindfoot, its function and the nature of the traumatic forces. The talus has an irregular shape with articular surfaces for tibia, fibula, calcaneus and navicular. It functions as a complex universal join...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1976-11-01 00:00:00
abstract：:Traditional imaging methods used in the detection and evaluation of metastatic bone disease lack either sensitivity (plain radiography) or specificity (bone scintigraphy). Magnetic resonance imaging now has been shown to be the most sensitive imaging technique available for the detection of bone metastases. On T1-weig...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章,评审
doi：
更新日期：1995-03-01 00:00:00
abstract：:Malignant tumors around fracture fixation implants have been reported sporadically for many years. Recently, however, reports of sarcomatous degeneration around a standard cemented hip arthroplasty and around cobalt-chromium-bearing hip arthroplasties raise new questions of the malignant potential of metallic ends pro...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1987-03-01 00:00:00
abstract：:Thirty intraarticular calcaneal fractures were studied by computed tomography and then treated with a variety of closed methods. A classification of the fractures was devised according to the amount of displacement of the posterior facet. Follow-up evaluation showed that Type I fractures recovered function and healed ...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1993-05-01 00:00:00
abstract：:Pain in the anterior knee has become synonymous with patella chondromalacia. However, pain also is the first sign of a tumor of the patella. Tumors of the patella are rare, but they often are mistaken for other benign lesions. Benign tumors of the patella are more frequent than malignant tumors (73% versus 27%). The m...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：10.1097/00003086-200108000-00007
更新日期：2001-08-01 00:00:00
abstract：BACKGROUND:Clinical research in orthopaedics typically reports the presence of an association after rejecting a null hypothesis of no association using an alpha threshold of 0.05 at which to evaluate a calculated p value. This arbitrary value is a factor that results in the current difficulties reproducing research fin...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章,评审
doi：10.1097/CORR.0000000000000843
更新日期：2019-10-01 00:00:00
abstract：:When inserting screws into a vertebral pedicle, the surgeon usually exposes the back part of the vertebra and uses his or her anatomic knowledge to align the drill in the proper direction. A slight error in direction may result in an important error in the position of the tip of the screw. This is done with no direct ...
journal_title：Clinical orthopaedics and related research
pub_type： 临床试验,杂志文章
doi：10.1097/00003086-199704000-00011
更新日期：1997-04-01 00:00:00
abstract：:Periosteal osteosarcoma is a surface lesion without evidence of medullary involvement. This report extends the Mayo Clinic series of periosteal osteosarcoma cases from 11 to 22 cases. In a review of demographic information from our 22 cases and from 30 additional cases, referred only for pathologic diagnosis, the aver...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1987-06-01 00:00:00
abstract：BACKGROUND:The navigation system was introduced to orthopaedic surgery in the 1990s. More recently, CT-based navigation systems have been used more commonly in spine and joint replacement surgery because of their precision. QUESTIONS/PURPOSES:The aim of our study was to evaluate the accuracy and efficacy of navigation...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：10.1007/s11999-011-2094-5
更新日期：2012-01-01 00:00:00
abstract：:Two hundred cases of intracapsular femoral neck fractures have been treated with a multiple parallel pin technique similar to that originated by Austin Moore. The technique employs a personally designed guide which facilitates insertion of multiple parallel pins. The fixation obtained satisfactorily resists shear stre...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1978-11-01 00:00:00
abstract：:The histopathologic changes leading to rotator cuff rupture are gradual and progressive. Incomplete tears can be observed in the articular or bursal surface. These partial lesions are infrequently demonstrated with arthrography or bursography. Although structural variations in cuff integrity can be demonstrated with u...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章,评审
doi：
更新日期：1990-05-01 00:00:00
abstract：:This report is a prospective review of 450 low-friction arthroplasties (LFAs) performed by a single surgeon from 1972 to 1983 in a community hospital. The clinical results show sustained quality of the result over a maximum follow-up period of 11 years. The radiologic review shows a slight increase in the number and s...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1986-10-01 00:00:00
abstract：:To learn about the changes appearing in hip muscles after an above-knee amputation, 3-dimensional reconstructions of the hip and thigh region of 12 patients with above-knee amputations were made based on transverse magnetic resonance images. In all patients, the amputations were done at least 2 years before the study ...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1995-10-01 00:00:00
abstract：:The absolute treatment of extensively involved cases of Legg-Calvé-Perthes disease (LCPD) remains unsolved. The basic principle of adequate containment of the capital femoral epiphysis in its acetabulum while minimizing the disability time is widely accepted, but the definition of adequate containment and methods of a...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1980-07-01 00:00:00
abstract：:After permanent loss of the sciatic nerve, most patients eventually have problems with the insensate skin and need transitibial amputation. The authors have designed a long medial sensate myocutaneous flap down to the foot based on the saphenous branch of the femoral nerve that resulted in good sensation over the enti...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1998-02-01 00:00:00
abstract：:Nineteen patients had a severe neurologic deficit and persistent dysesthetic pain after total hip replacement. During surgery their limbs had been lengthened by 1.3 to 4.1 cm. Patients with other reasons for nerve injury such as hematoma, dislocation, or direct operative trauma were excluded. Also excluded were patien...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：10.1097/00003086-200401000-00027
更新日期：2004-01-01 00:00:00
abstract：:The aseptically loosened prosthesis provided a means for investigating the in vivo and in vitro activity of the cells associated with the loosening process in seven dogs. The cells were isolated and maintained in culture for sufficient periods of time so that their biologic activity could be studied as well as the eff...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1990-12-01 00:00:00
abstract：BACKGROUND:Three-dimensional imaging (CT and MRI) is the gold standard for detecting femoral head-neck junction malformations in femoroacetabular impingement, yet plain radiographs are used for initial diagnostic evaluation. It is unclear, however, whether the plain radiographs accurately reflect the findings on three-...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：10.1007/s11999-012-2510-5
更新日期：2012-12-01 00:00:00
abstract：:The techniques used in fixation of the femoral prosthesis in total hip replacement are often based on empiricism and raise questions about: venting the medullary canal with a catheter during the insertion of cement; the inclusion of blood into cement during insertion with possible deleterious effects; recementing a pr...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：10.1097/00003086-197509000-00018
更新日期：1975-09-01 00:00:00
abstract：:A human osteosarcoma cell line, HuO9, was established from a tumor that was heterotransplanted into athymic nude mice. Antiserum against nude mouse spleen cells was added to the early passage cultures to eliminate the host fibroblastic cells. The cell line retained a high activity of liver/bone/kidney-type alkaline ph...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1990-10-01 00:00:00
abstract：BACKGROUND:Postanesthesia care is a costly component of overall surgical care. In the ambulatory setting, regional anesthesia has been shown for multiple surgical procedures to either decrease postanesthesia care unit (PACU) length of stay (LOS) or completely bypass it altogether. This has not been demonstrated in a la...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：10.1007/s11999-013-3336-5
更新日期：2014-05-01 00:00:00
abstract：:Major vascular, nonthromboembolic complications of total hip arthroplasty are rare: only 23 have been reported over the last 20 years. This is a report of two additional cases. In an 84-year-old woman, the external iliac artery was lacerated following removal of the acetabular component. Two such injuries have been re...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1984-06-01 00:00:00
abstract：:Patients with cystic fibrosis have an increased risk for developing kyphosis and scoliosis. The risk for both kyphosis and scoliosis increases with age. The severity of kyphosis did not appear greater in the older age groups. Patients with retarded bone age may be more likely to have a significant spinal deformity. Th...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1978-03-01 00:00:00
abstract：:Three cases of an isolated femoral component failure of a hip surface replacement were treated by use of a press-fit bipolar prosthesis to articulate with the retained acetabular cup. At two to three years post-surgery (average, 31 months), these three conversions had good clinical function and maintained an acceptabl...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1986-07-01 00:00:00
abstract：:Osteochondral autografts of femoral condyles in dogs were frozen at different cooling velocities after exposure to either glycerol or dimethyl sulfoxide to determine the freezing regimen best suited for preservation of intact cartilage. Autografts were also subjected to hypothermic storage in tissue culture media for ...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：
更新日期：1985-07-01 00:00:00
abstract：BACKGROUND:For patients with failed surgical treatment of an infected TKA, salvage operations such as arthrodesis or above-knee amputation (AKA) may be considered. Clinical and institutional factors associated with AKA and arthrodesis after a failed TKA have not been investigated in a large-scale population, and the ut...
journal_title：Clinical orthopaedics and related research
pub_type： 杂志文章
doi：10.1007/s11999-017-5285-x
更新日期：2017-12-01 00:00:00
