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Biomedical subjects

K Søballe

Publications and source records attributed to K Søballe.

At least 19 recordsLinked to original sources
PubMed2006

Bone remodelling around HA-coated acetabular cups : a DEXA study with a 3-year follow-up in a randomised trial.

This study was designed to investigate bone remodelling around the cup in cementless THA. Previous studies indicate an advantage of better sealing of the bone-prosthesis interface by HA/TCP coating of implants, inhibiting polyethylene-induced osteolysis. One hundred patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy versus Trilogy Calcicoat (HA/TCP coated). The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric), with a modular 28-mm CrCo head. The Harris Hip Score (HHS) and bone mineral density (BMD) determined by DEXA scanning were used to study the effect. Measurements revealed no difference between the two groups after 3 years either in the clinical outcome or in terms of periprosthetic bone density. Patients with a body mass index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodelling.

Absorptiometry, Photon↗
PubMed2006

Efficacy of multimodal optimization of mobilization and nutrition in patients undergoing hip replacement: a randomized clinical trial.

BACKGROUND: The aim of this trial was to assess the effects of optimization of mobilization and nutrition on patients undergoing primary total hip replacement (THR). METHODS: Seventy-nine patients undergoing elective primary THR were recruited prospectively. After randomization, one group received optimized pre-operative information and enforced mobilization and nutrition, another group received conventional peri-operative care. Epidural anaesthesia and post-operative epidural analgesia with local anaesthetics and opioids were used in all cases. Outcome related to length of stay, complications, pain, mobilization, energy intake, and physical activities of daily living (PADL). RESULTS: Although mobilization and nutrition were highly significantly increased in the intervention group, the reduction in length of stay was moderate (7.0 vs. 8.0 days P = 0.019). We found no differences between groups in relation to complications or pain. In the intervention group, the median day of independence in PADL was the third post-operative day (2 : 6 day) and the fourth post-operative day (2 : 7 day) in the control group. The difference was not significant. CONCLUSION: Compared with conventional care, optimal and aggressive nutrition and mobilization resulted in a very moderate reduction in length of stay. There were no differences regarding pain, complications or time until independence in PADL.

Activities of Daily Living↗
PubMed2006

Patient-related predictors of implant failure after primary total hip replacement in the initial, short- and long-terms. A nationwide Danish follow-up study including 36,984 patients.

We examined the association between patient-related factors and the risk of initial, short- and long-term implant failure after primary total hip replacement. We used data from the Danish Hip Arthroplasty Registry between 1 January 1995 and 31 December 2002, which gave us a total of 36 984 patients. Separate analyses were carried out for three follow-up periods: 0 to 30 days, 31 days to six months (short term), and six months to 8.6 years after primary total hip replacement (long term). The outcome measure was defined as time to failure, which included re-operation with open surgery for any reason. Male gender and a high Charlson co-morbidity index score were strongly predictive for failure, irrespective of the period of follow-up. Age and diagnosis at primary total hip replacement were identified as time-dependent predictive factors of failure. During the first 30 days after primary total hip replacement, an age of 80 years or more and hip replacement undertaken as a sequela of trauma, for avascular necrosis or paediatric conditions, were associated with an increased risk of failure. However, during six months to 8.6 years after surgery, being less than 60 years old was associated with an increased risk of failure, whereas none of the diagnoses for primary total hip replacement appeared to be independent predictors.

Adolescent↗
PubMed2005

Particle migration and gap healing around trabecular metal implants.

Bone on-growth and peri-implant migration of polyethylene particles were studied in an experimental setting using trabecular metal and solid metal implants. Cylindrical implants of trabecular tantalum metal and solid titanium alloy implants with a glass bead blasted surface were inserted either in an exact surgical fit or with a peri-implant gap into a canine knee joint. We used a randomised paired design. Polyethylene particles were injected into the knee joint. In both types of surgical fit we found that the trabecular metal implants had superior bone ongrowth in comparison with solid metal implants (exact fit: 23% vs. 7% [p=0.02], peri-implant gap: 13% vs. 0% [p=0.02]. The number of peri-implant polyethylene particles was significantly reduced around the trabecular metal implants with a peri-implant gap compared with solid implants.

Aluminum↗
PubMed2005

Prospective bone density changes after periacetabular osteotomy: a methodological study.

We used computed tomography (CT) and 3D design-based sampling principles (stereology) to estimate changes in acetabular bone density after periacetabular osteotomy. We included six consecutive patients with hip dysplasia in the study. Baseline density was measured within the first 7 days following periacetabular osteotomy and compared with bone density 2 years later. Double measurements were performed on three patients, and the coefficient of error of the mean was estimated to 0.05. Bone density in zone 1 increased significantly in the anteromedial quadrant as well as in the posteromedial quadrant of the acetabulum. In the anterolateral and the posterolateral quadrant, bone density was unchanged. In zone 2 and 3, bone density was unchanged 2 years postoperatively. We suggest that the observed increase in bone density medially represents a remodelling response to an altered load distribution after osteotomy. The method used is a precise tool to estimate changes in acetabular bone density.

Acetabulum↗
PubMed2005

No effect of platelet-rich plasma with frozen or processed bone allograft around noncemented implants.

We compared processed morselized bone allograft with fresh-frozen bone graft around noncemented titanium implants. Also, the influence of platelet-rich plasma (PRP) in combination with bone allograft was evaluated. Analysis was based on implant fixation and histomorphometry. PRP was prepared by isolating the buffy coat from autologous blood samples. Bone allograft was used fresh-frozen or processed by defatting, freeze drying, and irradiation. Cylindrical hydroxyapatite-coated titanium implants were inserted bilaterally in the femoral condyles of eight dogs. Each implant was surrounded by a 2.5-mm concentric gap, which was filled randomly according to the four treatment groups--group 1: fresh-frozen bone allograft; group 2: processed bone allograft; group 3: fresh-frozen bone allograft + PRP; group 4: processed bone allograft + PRP. Histological and mechanical evaluation demonstrated no influence of bone allograft processing. Even though the level of platelet in PRP was 7.7 times that found in whole blood, we found no improvement of bone formation or implant fixation by adding PRP.

Animals↗
PubMed2005

Joint space width in dysplasia of the hip: a case-control study of 81 adults followed for ten years.

In a longitudinal case-control study, we followed 81 subjects with dysplasia of the hip and 136 control subjects without dysplasia for ten years assessing radiological evidence of degeneration of the hip at admission and follow-up. There were no cases of subluxation in the group with dysplasia. Neither subjects with dysplasia nor controls had radiological signs of ongoing degenerative disease at admission. The primary radiological discriminator of degeneration of the hip was a change in the minimum joint space width over time. There were no significant differences between these with dysplasia and controls in regard to age, body mass index or occupational exposure to daily repeated lifting at admission. We found no significant differences in the reduction of the joint space width at follow-up between subjects with dysplasia and the control subjects nor in self-reported pain in the hip. The association of subluxation and/or associated acetabular labral tears with dysplasia of the hip may be a conditional factor for the development of premature osteoarthritis in mildly to moderately dysplastic hips.

Adult↗
PubMed2004

Early periprosthetic femoral bone remodelling using different bearing material combinations in total hip arthroplasties: a prospective randomised study.

The present study was performed to test the hypothesis that different bearing materials have an impact on femoral bone remodelling within the first year after a total hip arthroplasty. A total of 225 patients with osteoarthrosis of the hip or avascular necrosis of the femoral head were included in this randomised prospective study. All patients had an identical hybrid total hip arthroplasty (cemented BiMetric stem and cementless RingLoc acetabular cup) except for the bearing materials: polyethylene-on-zirconia (n = 78), CoCr-on-CoCr (n = 71), or alumina-on-alumina (n = 76). Bone mineral density (BMD) was measured with Dual-energy X-ray absorptiometry (DEXA) in seven Gruen zones adjacent to the femoral implant. The DEXA scan was performed within one week after surgery and was repeated one year postoperatively. There was no significant difference in periprosthetic BMD change between the three groups. After twelve months the relative BMD decrease was highest in the proximal part of the femur, - 6.2% in the greater trochanter region and - 12.7% in the lesser trochanter region. In the distal zones the relative BMD decrease was -5.3, -4.2, -2.1, -2.3, and -5.6%, respectively. The use of different bearing materials had no significant impact on femoral bone remodelling adjacent to the cemented hip stem within one year after surgery.

Aged↗
PubMed2004

Factors influencing hip joint space in asymptomatic subjects. A survey of 4151 subjects of the Copenhagen City Heart Study: the Osteoarthritis Substudy.

OBJECTIVE: The aims of the study were to investigate the distribution of hip joint space width (JSW) in asymptomatic subjects without radiologic evidence of degeneration, and investigate the influence of age, sex, physical parameters, occupational activity, and smoking on JSW. MATERIALS AND METHODS: The distribution of minimum JSW was determined in hip joints in standardized, weight-bearing pelvic radiographs of the Copenhagen City Heart Study: The Osteoarthritis Substudy cohort of 4151 subjects. Asymptomatic subjects without radiologic osteoarthritis were included (1018M/1554F). Occupational exposure to repeated daily lifting, smoking, and physical parameters were registered for each individual. RESULTS: Overall, female minimum JSW was significantly smaller compared with male JSW (P < 0.0001). Female minimum JSW decreased significantly with age (P < 0.0001), while male minimum JSW remained relatively unaltered throughout life (P(right) = 0319, P(left) = 0.18). Minimum JSW correlated positively with height, weight, and BMI, as did femoral head radius. Multiple logistic regression analysis revealed significant influence of sex and age on minimum JSW in females only. Positive or adverse effects of cigarette smoking on hip JSW were not documented. Type and duration of occupational exposure to repeated daily lifting did not affect hip JSW significantly. CONCLUSION: Minimum JSW decreased progressively with age in women, while it was unaltered in men. A history of smoking or different occupational exposure to repeated daily lifting did not influence minimum hip JSW significantly. Differences in body mass index, height or weight did not significantly influence minimum hip joint JSW.

Adult↗
PubMed2004

Platelet rich plasma and fresh frozen bone allograft as enhancement of implant fixation. An experimental study in dogs.

Platelet rich plasma (PRP) is an autologous source of growth factors. By application of PRP around cementless implants alone or in combination with bone allograft chips, early implant fixation and gap healing could be improved. We inserted two porous HA coated titanium implants extraarticularly in each proximal humerus of eight dogs. Each implant was surrounded by a 2.5 mm gap. Four treatments were block randomized to the four gaps in each dog: Treatment 1: empty gap, treatment 2: PRP, treatment 3: fresh frozen bone allograft, treatment 4: fresh frozen bone allograft+PRP. PRP was prepared from each dog prior to operation by isolating the buffycoat from centrifuged blood samples. Platelet count in PRP was increased 670% compared to baseline level. Calcium/thrombin was added to degranulate platelets and form a gel. Three weeks after surgery, push-out test and histomorphometri was performed. After three weeks, the non-allografted implants had poor mechanical properties. Bone grafting significantly increased implant fixation, bone formation in the gap and bone growth on the implant surface. We found no significant effect of PRP alone or mixed with bone allograft on implant fixation or bone formation. In conclusion, we showed the importance of bone allografting on early implant fixation and bone incorporation but we found no effect of PRP. More studies are needed to investigate the effect and possible clinical applications of platelet concentrates which are now being commercialised.

Animals↗
PubMed2004

In vivo gene delivery to articular chondrocytes mediated by an adeno-associated virus vector.

PURPOSES: (1) To investigate the efficiency of direct in vivo adeno-associated virus (AAV) vector-mediated gene transduction to chondrocytes in relation to normal and injured articular cartilage. (2) To evaluate the effects of ultra-violet light-activated gene transduction (LAGT) in chondrocytes in vivo. (3) To determine dissemination of active rAAV vector after intra-articular administration. METHODS: Rabbit knees with either normal or injured cartilage received an intra-articular injection with 1.5x10(12) infectious rAAV-eGFP particles. The right knees received rAAV-eGFP alone, whereas the left knees were given LAGT-treatment. The transduction efficiencies were determined at 1 and 3 weeks after infection by fluorescence-activated cell scanning. The occurrence of active shedding was monitored in serum and various tissues. RESULTS: After 1 week, 7% of the chondrocytes in normal cartilage were transduced by direct rAAV transduction technique. Chondrocytes in cartilage defects demonstrated higher transduction rates compared to chondrocytes in normal cartilage. LAGT increased the cellular eGFP expression in the internal zones to 12%, but did not have any effect in the external zones in defects. Finally, infectious particles were not detected in either serum or tissue samples. CONCLUSIONS: Direct rAAV-mediated gene transfer in vivo to articular chondrocytes is possible. LAGT improves rAAV transduction of chondrocytes in vivo but appears to have a very limited range of effect induction. Expression of eGFP was not determined in other tissues than synovium and cartilage in the treated joints.

Animals↗
PubMed2002

Effects of short-term alendronate treatment on the three-dimensional microstructural, physical, and mechanical properties of dog trabecular bone.

The bisphosphonate, alendronate, is well known for its potent inhibition of osteoclast-mediated bone resorption. It has been used clinically for the treatment of osteoporosis and has also recently been used to reduce osteolysis around prostheses in a canine revision model of implant loosening (femoral condyle). In this study, the effects of alendronate on trabecular bone properties were assessed in dogs at an oral dose of 0.5 mg/kg per day over a 12 week period, and compared with control dogs. Cubic cancellous bone specimens were produced from lumbar vertebrae (L-1 and L-2) and bilateral proximal humeri. These specimens were scanned using a high-resolution microcomputed tomography (micro-CT) system. From accurate data sets, three-dimensional microstructural properties were calculated and physical and mechanical properties were determined. Treatment with alendronate increased bone volume fraction by 9.5%, 7.7%, 7.4%, and 18.4%, respectively, in L-1, L-2, humeral greater tuberosity, and humeral head trabecular bone. In the lumbar vertebrae, the alendronate-treated trabeculae were thicker and lower in bone surface-to-volume ratio. In the greater tuberosity, the alendronate-treated trabeculae were thicker, lower in bone surface-to-volume ratio, and less anisotropic. In the humeral head, the alendronate-treated trabeculae were thicker, less anisotropic, lower in surface density, and showed decreased trabecular separation. Alendronate significantly increased apparent density and collagen density in the lumbar vertebrae and humeral heads, and significantly decreased collagen concentration in the vertebrae. In the lumbar vertebrae, Young's modulus in the cephalocaudal direction, ultimate stress, and failure energy were significantly increased in the alendronate-treated group. The changes in mechanical properties in the humeral head trabecular bone were similar to those seen in the lumbar vertebrae. Our results demonstrate that alendronate increases the mechanical properties of healthy canine trabecular bone after short-term treatment. The physical and microstructural changes of trabecular bone are consistent with the significantly increased mechanical properties.

Alendronate↗
PubMed2002

Bone ingrowth in the presence of particulate polyethylene. Synergy between interface motion and particulate polyethylene in periprosthetic tissue response.

We have investigated whether the presence of polyethylene (PE) alone is sufficient to cause an aggressive periprosthetic tissue response, or whether certain mechanical interface conditions can allow bone to grow while in the presence of PE. An experimental implant was loaded in the presence and absence of particulate PE under stable and unstable conditions. Bone with a thin, discontinuous fibrous membrane formed in both groups of stable implants, either in the presence or absence of PE. By contrast, a continuous fibrous membrane consistently formed in both groups of unstable implants. The membrane consisted of loose fibrous connective tissue when PE was absent, and dense connective tissue with macrophages and a synovial lining when PE was present. In this model, if the interface was stable, the presence of PE was not sufficient to prevent the formation of bone or to produce a phagocytic tissue response. Only when the interface was unstable did a fibrous membrane form, and only then in the presence of PE.

Animals↗
PubMed2001

Loading improves anchorage of hydroxyapatite implants more than titanium implants.

Roentgen Stereophotogrammetric Analysis (RSA) studies have shown that the quality of the early fixation of implants has a dominant effect on their long-term function. To evaluate methods to improve their fixation, we examined the influence of mechanical loading and surface coating on the quality of the bone-implant interface. We compared the fixation of a cylindrical, stable 6.0 mm implant initially surrounded by a 0.75 mm concentric gap, after 4 weeks of loaded or unloaded conditions. Two types of surfaces were analyzed: plasma sprayed hydroxyapatite (HA) and plasma sprayed titanium (Ti). The histomorphometric evaluation showed that HA implants had greater bone coverage than Ti implants, and this coverage was further increased under loaded conditions only for HA. Furthermore, loading reduced the fibrous tissue coverage for the HA implants, while it increased fibrous tissue coverage for Ti implants. These findings were in agreement with pushout results showing that HA implants had greater shear strength, stiffness, and energy than Ti implants, and (except for energy) these parameters were further increased under loaded conditions only for HA. In addition, because the two implant surfaces exhibited a different relative response to load, it is important to evaluate new surfaces under the more clinically relevant loaded condition.

Animals↗
PubMed2001

Effect of osteogenic protein 1/collagen composite combined with impacted allograft around hydroxyapatite-coated titanium alloy implants is moderate.

This study evaluated the effects of osteogenic protein 1/collagen composite (OP-1/col) mixed with impacted allograft around hydroxyapatite (HA)-coated titanium alloy implants in a canine model. The aim of the study was to test different doses of OP-1 growth factor in a collagen composite for stimulatory effect on allograft incorporation around an implant. Unloaded implants were inserted in each proximal humerus of 16 skeletally mature dogs. The cylindrical implants (4 x 9 mm) coated with HA were initially surrounded by a 3-mm gap into which allograft mixed with OP-1/col was impacted. Two different doses of OP-1 were investigated. In eight animals 325 mg OP-1 protein and 130 mg bovine collagen type I as carrier were mixed with the allograft chips. This composite is identical to the clinically used OP-1 device called Novus. In another eight animals a lower dose of 65 mg OP-1 protein and 130 mg bovine collagen type I was used. Control implants placed in the contralateral humerus were surrounded by allograft mixed with collagen carrier only. The dogs were euthanized at 6 weeks. Implant fixation was determined by push-out testing. Bone ingrowth and bone formation were evaluated by quantitative histomorphometry on serial sections of the bone-implant interface. Impacted allograft together with low-dose OP-1 enhanced bone volume in a zone adjacent to HA-coated titanium alloy implants. The high dose had no effect on bone formation. Mechanical fixation, bone ingrowth, and bone volume in the gap near the original trabecular bone were unaffected by both low and high OP-1/col composite. In this model and observation period, the low dose of OP-1/col composite mixed with impacted allograft has a moderate effect on bone healing around HA-coated implants and no effect on implant fixation.

Animals↗
PubMed2001

Transforming growth factor-beta1 adsorbed to tricalciumphosphate coated implants increases peri-implant bone remodeling.

Increasing experimental interest has emerged for the use of growth factors to stimulate bone healing and bone formation in various clinical situations. We and others have demonstrated that recombinant human transforming growth factor-beta1 (rhTGF-beta1) adsorbed onto tricalcium phosphate (TCP)-coated implants can improve mechanical fixation and bone ongrowth. The present study evaluated bone remodeling in newly formed bone and adjacent trabecular bone around TCP-coated implants with and without rhTGF-beta1 adsorption. Unloaded cylindrical grit-blasted titanium alloy implants coated with TCP were inserted bilaterally into the femoral condyles of 10 skeletally mature mongrel dogs. The implants were initially surrounded by a 2 mm gap. Implants with 0.3 microg rhTGF-beta1 were compared with implants without growth factor. The dogs were sacrificed after six weeks. Bone remodeling was evaluated by histomorphometry on Goldner-stained undecalcified sections. The bone volume in the gap was increased significantly from 17.6% in the control group to 25.6% in the rhTGF-beta1 group (p = 0.03). Also bone surface was increased in the rhTGF-beta1 group. The osteoclast covered surfaces were increased from 3.6% in the control group to 5.9% in the rhTGF-beta1 group (p = 0.02). In the surrounding trabecular bone no significant changes in bone remodeling parameters was demonstrated. This study suggests that rhTGF-beta1 adsorbed onto TCP-ceramic coated implants accelerates repair activity in the newly formed bone close to the implant, but it does not seem to influence bone remodeling in preexisting bone at a greater distance from the implant.

Adsorption↗
PubMed2001

A controlled experimental model of revision implants: Part I. Development.

We investigated the roles of particulate matter with unstable implant, in engendering the aggressive tissue response associated with implant loosening in humans. This study serves as a basis for establishing a controlled animal model to reproduce the conditions present after implant loosening. The model includes a 6 mm polymethylmethacrylate (PMMA) cylinder concentrically pistoning 500 microm under load in a 0.75-mm circumferential gap, inserted into canine medial femoral condyles for 8 weeks. We evaluated two size concentrations of polyethylene: type A particulate polyethylene (0.5-12 microm), and type B particulate polyethylene (0.5-50 microm; 85% < 12 microm). The following three treatment groups were investigated in 28 unstable implants in 14 dogs: (1) without polyethylene (control), (2) with type A polyethylene, and (3) with type B polyethylene. We found an aggressive periprosthetic membrane, similar to that seen at revision in humans, only in the unstable implant with polyethylene. The features of this membrane included macrophages with intracellular polyethylene, a dense fibrous membrane with a synovial-like lining layer, and a sclerotic neocortex. The size distribution of the polyethylene did not alter the tissue response. An unstable implant without polyethylene resulted in a benign, quiescent membrane with loose fibrous connective tissue. The model creates a revision cavity analogous to that seen in revision joint arthroplasty, and merits further studies of revision joint replacement.

Animals↗