Improved cartilage repair after treatment with low-intensity pulsed ultrasound.

Low-intensity pulsed ultrasound accelerates bone healing via upregulation of cartilage formation and maturation phases of endchondral bone formation. The current authors evaluated the effect of ultrasound therapy on the repair of full-thickness osteochondral defects. Bilateral, 3.2 mm diameter by 5.0 mm deep osteochondral defects were created in the patellar groove of 106 adult male New Zealand rabbits. The defects were treated with daily low-intensity pulsed ultrasound therapy on the right knee. The left knee was not treated. In Part I, the effect of ultrasound therapy was evaluated at 4, 8, 12, 24, and 52 weeks after surgery. In Part II, the effect of the length of treatment (5, 10, or 40 minutes of daily ultrasound therapy) compared with standard 20 minute therapy was evaluated. The repair cartilage was evaluated and graded on a standard scale for the gross and histologic appearance. Ultrasound treatment significantly improved the morphologic features and histologic characteristics of the repair cartilage compared with nontreated controls. Earlier, better repair with less degenerative changes at later times was observed in defects treated with ultrasound. Doubling the treatment time to 40 minutes daily significantly increased the histologic quality of the repair cartilage. In the current animal model, daily low-intensity pulsed ultrasound had a significant positive effect on the healing of osteochondral defects.

The effect of osteogenic protein-1 on the healing of segmental bone defects treated with autograft or allograft bone.

BACKGROUND: Large amounts of bone graft are frequently used to elicit the healing of bone defects resulting from reconstructive procedures. Autograft and allograft bone are often used, but each has its limitations. Bone morphogenetic proteins (BMPs) improve the healing of segmental bone defects treated with autograft or allograft. The objective of the present study was to determine the effect of implantation of a recombinant osteogenic protein-1 (OP-1) in combination with bone graft on the healing of a critical-sized (2.5-cm) segmental defect in canine ulnae. METHODS: Either autograft bone, allograft bone, osteogenic protein-1 (OP-1) mixed with type-1 bovine collagen, or various combinations of OP-1 and collagen (OP-1 device) mixed with allograft or autograft were implanted in the segmental bone defects. The combinations included 67% bone graft with 33% OP-1 device and 33% bone graft with 67% OP-1 device. The healing of the defects was assessed with radiographic, biomechanical, and histological studies. The animals were killed at twelve weeks postoperatively. RESULTS: The use of the OP-1 device alone or any combination of autograft or allograft bone and the OP-1 device demonstrated improved healing on radiographic, mechanical, and histological studies compared with that demonstrated after use of autograft or allograft bone alone. The highest radiographic and histological grades and the greatest mechanical strength were achieved with the use of 33% allograft and 67% OP-1 device, although no significant differences were observed among the different groups containing the OP-1 device. At twelve weeks postoperatively, the defects treated with any amount of the OP-1 device obtained greater mechanical strength than that obtained by autograft bone alone. CONCLUSIONS: Major bone defects may be treated with allograft bone combined with the OP-1 device, instead of autograft alone, to avoid complications associated with the use of autograft. The combination of allograft bone and the OP-1 device resulted in optimum healing of the defect, according to the radiographic, mechanical, and histological parameters measured in this study. CLINICAL RELEVANCE: The combination of freeze-dried allograft bone with the OP-1 device is an attractive graft material for the treatment of large bone defects. Although similar results were observed when autogenous bone graft was used in combination with the OP-1 device, the results of the present study suggest that allograft, because of its relatively unlimited supply, can be substituted without reduced efficacy. In addition, avoiding the need to harvest autogenous bone eliminates the additional operative time and risk associated with a second surgical procedure.

Biomechanical testing and clinical experience with the OMEGA-21 spinal fixation system.

The role of spinal instrumentation is to provide mechanical stability, obtain and maintain anatomic alignment, and promote fusion. The American Society for Testing and Materials (ASTM) introduced guidelines and procedures so that biomechanical properties of different implant designs could be compared in a consistent manner. Combined with biomechanical analyses, clinical evaluation allows the safety and efficacy of a spinal implant system to be determined before construction. The objective of our study was to determine the biomechanical properties and clinical performance of the OMEGA-21 Spinal Fixation System. Static and dynamic (fatigue) biomechanical testing was performed per ASTM guidelines and recommendations on individual components and on the system assembled in a corpectomy model. Clinical and radiographic evaluation of 57 consecutive patients with indications for instrumented spinal arthrodesis of the lower dorsal lumbar and sacral segments of the spine was performed at a mean follow-up of 31.9 months. Static and fatigue testing revealed superior biomechanical properties of the individual components and of the assembled system. The mechanical-strength values of the system were comparable with maximum reported values for existing implant designs. At final clinical follow-up, 86% of patients obtained relief of their symptoms; 84% considered their clinical results to be excellent or good. Ninety-one percent of patients satisfied radiographic criteria for bony fusion. There were 5 implant-related complications: 2 misplaced screws (2 patients), local pain above the implant (2 patients), and 2 broken expansive screws (1 patient). Biomechanical and clinical results indicate that the OMEGA-21 system is feasible and performs well as a spinal instrumentation system for the lower dorsal, lumbar, and sacral spine.

Low-intensity pulsed ultrasound improves spinal fusion.

BACKGROUND CONTEXT: Increasing the incidence of solid bony fusion is a primary goal in spine surgery. Daily low-intensity pulsed ultrasound therapy has been shown to improve and accelerate the bone healing process. PURPOSE: The purpose of this study was to evaluate the efficacy of daily low-intensity pulsed ultrasound therapy to improve the rate and quality of spinal fusion. STUDY DESIGN: Canine fusion model prospective study. PATIENT SAMPLE: Fourteen adult male dogs were used. OUTCOME MEASURES: Radiographic grading of plain films, computed tomography (CT) and magnetic resonance imaging (MRI), gross palpation, torsional stiffness and histologic grading were used to determine the presence or absence of fusion. METHODS: Posterior noninstrumented bilateral fusions were evaluated at the L2-L3 and L5-L6 levels. Treatment with low-intensity pulsed ultrasound for 20 minutes per day over the fusion site (stimulated) was compared with fusion sites that received no stimulation (nontreated controls) at 6 and 12 weeks after surgery. Plain film radiographs, CT and MRI, mechanical torsion testing and histologic examination were performed. RESULTS: At 6 weeks, ultrasound treated sites were more frequently fused compared with nontreated controls, although the difference in fusion rate was not statistically significant. At 12 weeks after surgery complete radiographic and histologic fusion occurred in 100% of ultrasound-treated sites. In the nontreated control sites 78% had achieved complete radiographic fusion and 44% had complete histologic fusion. Compared with control sites, the histological and mechanical fusion rate was significantly greater in ultrasound-treated sites (P<.05) at 12 weeks. A statistically significant increase in mechanical stiffness in ultrasound-treated sites was also found at 12 weeks after surgery. CONCLUSIONS: Low-intensity pulsed ultrasound therapy may be a useful means to ensure successful spine fusion.

Lumbosacral fixation using expandable pedicle screws. an alternative in reoperation and osteoporosis.

BACKGROUND CONTEXT: Pedicle screw fixation in osteoporotic bone and in revision of previous pedicle screw fixation cases presents a significant challenge to spine surgeons. Biomechanical tests have shown that a pedicle screw that expands within the vertebrae body can substantially improve fixation in the presence of compromised bone. PURPOSE: To review the clinical and radiographic results with the use of expandable pedicle screws. STUDY DESIGN: One hundred forty-five patients received one or more expandable pedicle screws from the Omega21 spinal fixation system (EBI, L.P., Parsippany, NJ) to obtain thorocolumbar or lumbosacral stabilization. PATIENT SAMPLE: The indications for use of the expandable screws were osteoporosis (21 cases), reoperation of previous pedicle instrumentation (27 cases), intraoperative screw relocation (17 cases), construct reinforcement (23 cases), and sacral anchoring to avoid the necessity of anterior penetration of the sacral cortex (57 cases). OUTCOME MEASURES: The presence of radiographic fusion and complications arising from the instrumentation were reviewed at a mean follow-up period of 35 months (range, 24-72 months). METHODS: A retrospective clinical and radiographic review was performed. Fusion was evaluated based on anterior-posterior and lateral radiographs as well as dynamic radiographs in flexion and extension. RESULTS: Radiographic evidence of fusion was obtained in 125 of the 145 cases (86%). Eighty-six percent of patients with osteoporosis and 89% of reoperations fused. There were no instances of screw loosening or pullout of the expandable screws. Screw breakage occurred in four patients (2.8%), including three patients where fusion was not obtained. In six patients the expandable screws were removed without difficulty after fusion because of local discomfort. CONCLUSION: The results of this study have shown that expandable pedicle screws can be efficacious in cases in which pedicle screw fixation is difficult and adds a valuable tool to the growing armamentarium of spinal instrumentation.

The Otto Aufranc Award. Strut allograft healing to the femur with recombinant human osteogenic protein-1.

Allograft struts are used to reinforce the deficient proximal femur in hip arthroplasty or for fixation of a periprosthetic fracture. Although the use of strut grafts wired or cabled to the proximal femur generally has been successful, the time for healing is slow. The purpose of the current study was to determine whether cortical strut graft healing to the femur could be enhanced by the addition of recombinant human osteogenic protein-1. Fourteen adult dogs underwent bilateral onlay allograft strut procedures to the midfemur using stainless steel cables. In each animal one femur received 500 mg of osteogenic protein-1 device (2.5 mg recombinant human osteogenic protein-1/g Type I collagen) interposed between the graft and host bone. The results showed that the healing of cortical strut grafts to the femur was enhanced dramatically by the addition of the osteogenic protein-1 device. The sites treated with osteogenic protein-1 had significantly greater radiographic, histologic, and microradiographic scores at all times. Rapid formation of new bone and graft incorporation was observed in sites treated with the osteogenic protein-1 device. Strut healing with the osteogenic protein-1 device at 4 weeks postoperative was superior to the healing in control sites at 8 weeks. Improving and accelerating the course of cortical strut graft healing should provide a substantial clinical benefit in lowering the risk of graft nonunion and fracture and shorten the time of protected weightbearing and functional disability.

Biomechanical evaluation and preliminary clinical experience with an expansive pedicle screw design.

The advantages of pedicle screw fixation depend on their ability to retain bony purchase until the fusion mass is stable. Osteoporotic bone and removal and replacement of pedicle screws in revision procedures substantially reduce screw mechanical fixation strength and can lead to clinical failure. The objective of this study was to determine if an expansive pedicle screw design could be used to improve biomechanical fixation in bone of compromised quality. Axial mechanical pullout testing was performed on paired expansive and conventional pedicle screws placed in fresh, unembalmed cadaveric vertebrae. Bone mineral density measurements (made using a dual-energy X-ray absorption meter) were used to characterize bone quality. A preliminary clinical and radiographic evaluation of 14 patients was also performed at a minimum 2-year follow-up. The mean axial pullout force in bone of all qualities was increased 30% when the expansive pedicle screw design was used. This included an appropriate 50% increase in pullout force in bone of poor quality (low bone mineral density). The preliminary clinical and radiographic results were supportive of the biomechanical design rationale and mechanical testing. The results were similar to those expected for spinal instrumentation using pedicle screws, even though compromised bone was present in two thirds of the cases in which the expansive screw was used.

Histologic analysis of implant sites after grafting with demineralized bone matrix putty and sheets.

Grafting to restore lost alveolar bone is frequently used to enable placement of endosseous implants and improve cosmesis. Conflicting reports concerning the osteoinductivity of demineralized bone matrix (DBM) and historical use of synthetic bone graft substitutes has limited the use of DBM in oral and maxillofacial applications. Implant placement after bone grafting provides the unique opportunity to biopsy and histologically evaluate new bone formation. Bone grafting of the mandible or maxilla was performed to fill extraction sockets and restore ridge structures in a consecutive series of eight patients. DBM prepared as malleable putty (Grafton DBM Putty) or flexible sheets (Grafton DBM Flex) was used. Biopsies were taken at reentry, and histologic analysis determined the amount and quality of regenerated bone. Extensive new bone formation and minimal residual bone graft matrix were observed at an average of 5 months postoperative. The pattern of new bone maturity and remodeling varied by patient and the time in situ. Putty and Flex regenerated excellent bone height and width for the placement of dental implants, were easy to handle intraoperatively, and readily conformed to bony defects.

Use of an osteoinductive biomaterial (rhOP-1) in healing large segmental bone defects.

OBJECTIVE: To assess the radiographic, histologic, and mechanical characteristics of new bone formation in large segmental bone defects treated with a new osteoconductive material, recombinant human osteogenic protein-1 (rhOP-1). DESIGN: In vivo animal study. INTERVENTION: Sixteen dogs (thirty-two limbs) with an ulna segmental defect (2.5 centimeters) were randomized to three treatment groups: rhOP-1, collagen alone, and no implant. MAIN OUTCOME MEASUREMENTS: Radiographic evidence of defect healing, mechanical testing (torsional strength) as compared with thirty-one control intact dog ulnas, and histologic analysis. RESULTS: At twelve weeks, complete radiographic healing was observed in twenty-five of twenty-eight defects (89 percent) treated with rhOP-1. The mechanical strength of the rhOP-1-treated defects at twelve weeks was 65 percent of that of intact ulnas. Histologic analysis revealed that defects treated with rhOP-1 were bridged with lamellar and woven bone that was in continuity with the host bone. CONCLUSIONS: The results indicate that osteoinductive materials, which have the ability to quickly fill and heal large defects, may have advantages over osteoconductive materials, which are typically used to fill smaller non-load-bearing bone voids.

Simian immunodeficiency virus (human HIV-II) transmission in allograft bone procedures.

STUDY DESIGN: Infection of rhesus monkeys (Macaca mulatta) with simian immunodeficiency virus (SIV, HIV-II) was used to study disease transmission in allograft bone. Four allograft bone processing techniques--fresh, fresh frozen, double freeze-thaw, and double freeze-thaw with chemical decontamination--were evaluated. OBJECTIVES: To determine if SIV could be transmitted in allograft bone and if processing techniques could be used to eliminate the potential for disease transmission. SUMMARY OF BACKGROUND DATA: Although the risk of HIV transmission in bone allograft was reported to be low, HIV transmission had occurred. In all cases, frozen allograft was used. Donor screening and serologic testing significantly reduced the risk of transmission, although a window of time existed in which an individual was infected but had not seroconverted. Experimental infection of rhesus monkeys with SIV induced a disease syndrome similar to AIDS and provided an ideal model to study disease transmission. METHODS: Corticocancellous cylinders were obtained aseptically from SIV-infected rhesus monkeys. The grafts were randomly placed into one of four processing groups and implanted into noninfected animals. The presence of SIV antibody was monitored by serologic testing. After the monkeys were killed, the graft sites were studied by histology. RESULTS: All animals receiving fresh allograft or allograft bone that had been subjected to either single or double -70 C freeze-thaw cycles became infected with SIV. Animals receiving allograft that had been subjected to a double freeze-thaw cycle and chemical decontamination were disease-free after 26 weeks when the animals were killed. CONCLUSIONS: The results show that SIV (HIV-II) can be transmitted in bone allograft procedures. Although freeze-thaw cycles and lavaging to remove blood elements can reduce the infectivity of a graft, it appears chemical decontamination is necessary to provide a high level of confidence in its safety.

Effect of recombinant human osteogenic protein-1 on healing of segmental defects in non-human primates.

The effect of recombinant human osteogenic protein-1 on the healing of segmental bone defects was studied in twenty-eight African green monkeys (Cercopithecus aethiops). A 2.0-centimeter osteoperiosteal defect was created in the middle of the ulnar shaft in fourteen animals and in the diaphysis of the tibia in the other fourteen. The ulnar defect was filled with an implant consisting of 1000 micrograms of recombinant human osteogenic protein-1 in 400 milligrams of bovine bone-collagen carrier in six animals, with collagen carrier alone in two animals, and with autogenous cancellous bone graft from the contralateral tibia and femur in six animals. The tibial defect was filled with 250, 500 (two tibiae), 1000, or 2000 micrograms of recombinant human osteogenic protein-1 in 400 milligrams of collagen carrier in five animals, with collagen carrier alone in one animal, and with autogenous cancellous bone graft in six animals; in the two remaining animals (controls), the tibial defect was left unfilled. The tibial defects were stabilized with an intramedullary Steinmann pin. All animals were killed at twenty weeks postoperatively. Healing of the defects was evaluated with biweekly radiographs, with histological examination, and with mechanical testing. Radiographically, all of the defects that had been treated with recombinant human osteogenic protein-1 exhibited new-bone formation, but they differed in the degree of healing and remodeling. Five of the six ulnae treated with recombinant human osteogenic protein-1 and four of the five tibiae treated with this substance exhibited complete healing at six to eight weeks, with bridging of the defect by new bone first observed at four weeks. The two unhealed defects both exhibited new-bone formation but incomplete union, which precluded mechanical testing. No defect that had been filled with collagen carrier or that had been left unfilled exhibited any signs of healing or major new-bone formation. None of the six ulnae that had been filled with autogenous bone graft exhibited complete healing, compared with five of the six tibiae that had been so treated. Histological evaluation of the defects treated with recombinant human osteogenic protein-1 revealed the formation of new cortices with areas of woven and lamellar bone and normal-appearing marrow elements at twenty weeks postoperatively. The tibial defects that had been treated with autogenous bone graft had a similar appearance. All control ulnar and tibial defects and all ulnar defects that had been treated with autogenous bone graft had fibrous union with little new-bone formation.(ABSTRACT TRUNCATED AT 400 WORDS)

Evaluation of recombinant human osteogenic protein-1 (rhOP-1) placed with dental implants in fresh extraction sites.

This study used the canine mandibular model to evaluate the efficacy of recombinant human osteogenic protein-1 (rhOP-1) for accelerating the healing of fresh dental extraction defects and in encouraging osseointegration of dental implants. Eight implants, four hydroxylapatite (HA)-coated and four non-coated, were placed in each mandible of four adult male mongrel dogs immediately after extraction of the eight premolars. The rhOP-1 was placed in all extraction sites with and without implants on the left side of the mandible. All animals were killed at 12 weeks postoperatively; histologic analysis was performed, including measurement of the new bone formation within the extraction defects, implant incorporation, and implant-bone interface characteristics, including percent bone and fibrous tissue apposition. Extraction sites treated with rhOP-1 were completely filled with new bone and were well incorporated with the host bone at 12 weeks post-operative. New bone had filled the untreated defect sites; however, the amount, density, and degree of remodeling were less than was observed in rhOP-1 sites. Small increases in osseointegration and adjacent new bone formation were apparent surrounding implants placed with rhOP-1. However, good initial implant fit and the small amount of rhOP-1 delivered to the site in this model may have mitigated any large differences. The results of this study demonstrate that new bone formation can be induced around and adjacent to a dental implant placed in a fresh extraction site with a recombinantly produced bone inductive protein.

Bone ingrowth into a porous-coated total shoulder component retrieved postmortem.

An uncemented porous-coated humeral component, which functioned in vivo for over 2 1/2 years, was retrieved postmortem and examined histologically. Radiographs of the specimen revealed close approximation to the endosteal cortex medially and laterally. Apposition was limited or absent anteriorly and posteriorly. The overall extent of bone ingrowth was approximately 11% of the available pore volume with over 95% of ingrowth occurring in the medial and lateral quadrants. Bone ingrowth was limited anteriorly and posteriorly to regions in which spot welds were identified radiographically. There were no loose beads or coating failure observed.

A biomechanical comparison of intramedullary nailing systems for the humerus.

This study evaluated the rotational and bending stability of three interlocking nail systems in paired cadaveric humeri. The Russell-Taylor Humeral Interlocking Nail, the Seidel Humeral Locking Nail, and the True-Flex Humeral Nail were mechanically tested in torsion and four-point bending. The Russell-Taylor and the Seidel interlocking nails are reamed systems that rely on proximal interlocking screws and distal screws or phalanges respectively for rotational stability. However, axillary nerve damage may result during proximal screw placement, and these systems exhibit low resistance to rotation. The True-Flex intramedullary nail is an unreamed system that relies on cross-sectional geometry to achieve rotational stability. By not relying on interlocking screws for stability, nerve damage associated with the screw placement may be eliminated. However, the results indicate the cross-sectional geometry of the True-Flex nail is not able to provide the same degree of static locking as the Russell-Taylor or Seidel interlocking nails. Humeri implanted with the Russell-Taylor and Seidel nails also had a significantly greater torsional stiffness than the True-Flex nail. As expected, humeri implanted with the Russell-Taylor and Seidel nails also had a significantly greater bending stiffness than the True-Flex nail in both anterior-posterior and medial-lateral bending.

The effect of surface macrotexture on the mechanical and histologic characteristics of hydroxylapatite-coated dental implants.

The interface attachment strength and histology of HA-coated endosseous dental implants with surface texturing added to allow for mechanical interlocking of the implant to bone were evaluated in the canine mandibular model. Twenty-two adult mongrel dogs received eight implants (four per side) placed into healed extraction sites. Fifteen weeks post-implantation, the implants were evaluated mechanically by axial pull-out and torsional testing. Following testing, the specimens were evaluated quantitatively for histologic parameters of bone apposition, HA-coating thickness, and mode of interface failure. The addition of surface macrotexture (threads, grooves, and dimples) was not found to have a significant effect on axial pull-out strength compared with smooth implant controls. Similarly, mechanical testing in torsion failed to reveal any significant effect on implant-bone interface attachment due to surface macrotexture. Interface failure occurred primarily at the HA/substrate interface in all implant designs. Examination of HA-coating thickness revealed non-uniform coatings, particularly in the surface-textured designs. Although bone growth into the surface textures was observed in some cases, often only minimal or a thin osseous layer on the HA coating was observed. This factor most likely contributed to the lack of significant additional interface attachment strength in the textured designs. The reduction in areas of complete implant incorporation may also have exposed the HA coating to high interfacial loads and may be responsible for the greater HA coating break-up and presence of particles observed in the textured designs.

An in vivo analysis of an elliptical dental implant design.

The interface attachment strength and histology of an elliptical hydroxylapatite-coated (HA) endosseous dental implant were compared with those of an otherwise identical cylindrical dental implant. The implant designs were tested in two canine in vivo models: healed mandibular extraction sites and the femoral unicortical plug. The implants were evaluated 15 weeks post-implantation. The elliptical geometry of the dental implant was not found significantly to enhance axial pull-out strength or torsional implant-bone interface attachment in either in vivo model. The cylindrical implant absorbed more energy to failure in both the mandible and the femur; however, the difference was not statistically significant. Differences in the interface shear attachment strength between the two models (mandible and femur) were statistically significant when the maximum load to failure was normalized by the actual bone contact surface area. In all cases, femoral values were significantly greater. Examination of HA-coating thickness revealed uniform coatings on both implant types which were well maintained in vivo. Mechanical failure occurred primarily at the metal substrate-HA interface in each type of implant in both models. The amounts of bone apposition to both implants in both models were identical. Coating break-up and inflammatory response to the particulate debris were minimal.