Ebbe Stender Hansen

Hydroxyapatite coating enhances fixation of porous coated implants: A comparison in dogs between press fit and noninterference fit

Intimate contact at the bone-porous surface interface is not always achievable in noncemented prosthetic implantation. We investigated the effect of hydroxyapatite (HA) coating on skeletal attachment in noninterference fit 4 weeks after implantation in 6 mature dogs. The push-out test of HA-coated implants surrounded by a 1-mm gap showed a twofold increased shear strength and fivefold increased shear stiffness compared with titanium alloy (Ti) coated implants. The fixation of Ti implants was reduced by two thirds when inserted in a gap as compared with press fit, whereas HA-coated implants in gap showed anchorage close to implants in press fit. Only minor differences were found between HA and Ti implants in press fit. Histomorphometric analysis showed a significant increase in bone in direct contact to HA-coated implant as compared with Ti implants inserted both in gap and press fit. The study indicates that tightness of surgical fit is an important factor for sufficient fixation of the implant. However, our results demonstrate that hydroxyapatite coating almost eliminates the negative influence of noninterference fit between bone and unloaded implant.

Hydroxyapatite coating modifies implant membrane formation. Controlled micromotion studied in dogs.

We studied the influence of controlled micromovements between bone and porous titanium alloy implants with and without hydroxyapatite coating. A dynamically loaded unstable device producing approximately 150-microns axial translation of knee implants during each gait cycle was developed. Stable implants served as controls. Matched stable and unstable implants with either porous titanium (Ti) or hydroxyapatite (HA) coating surrounded by a gap of 0.75 mm were inserted into the weight-bearing regions of the medial femoral condyles in 14 mature dogs. Histologic analysis after 4 weeks showed a fibrous membrane surrounding both types of implants subjected to micromovements, whereas various amounts of bone ingrowth was obtained in the stable implants. The membrane around unstable HA implants was thinner than that around unstable Ti implants. Islands of fibrocartilaginous tissue characterized the membrane around unstable HA implants, whereas fibrous connective tissue surrounded unstable Ti implants. The collagen concentration of the fibrous membranes was higher around unstable HA implants compared with Ti implants. Instability reduced the shear strength of the implants. However, the shear strength of unstable HA implants exceeded that of the Ti implants, both unstable and stable. The greatest shear strength was obtained by stable HA implants, i.e., tenfold greater than that of stable Ti implants. The gap-healing capacity around stable HA implants increased toward the HA surface, and was greater than that around Ti implants. Our study demonstrates that micromovements between bone and implant inhibit bone ingrowth and lead to the development of a fibrous membrane. The superior fixation of unstable HA implants compared with unstable Ti implants may be ascribed to the presence of fibrocartilage, a higher collagen concentration, and radiating orientation of collagen fibers in the membrane. The strongest mechanical anchorage and the greatest amount of bone ingrowth was obtained by stable implants coated with hydroxyapatite.

Long-Term Functional Outcome of Pedicle Screw Instrumentation as a Support for Posterolateral Spinal Fusion : Randomized Clinical Study With a 5-Year Follow-up

Study Design. A prospective randomized clinical study with a 5-year follow-up. Objectives. To analyze the long-term effect of supplementary transpedicular screw fixation on reoperation rate and functional outcome. Summary of Background Data. Within the past few years the benefit of supplemental pedicle screw fixation has been questioned as a standard procedure in lumbar spinal fusion surgery. The long-term effect of supplemental pedicle screw fixation is still unknown. Methods. From 1992 through 1994 a total of 129 patients with severe chronic low back pain were randomly selected for either supplemental pedicle screw fixation (instrumented) or no pedicle screw instrumentation (noninstrumented) posterolateral spinal fusion. The Dallas Pain Questionnaire, Low Back Pain Rating Scale, and a questionnaire concerning work status assessed the outcome. Results. A 5-year follow-up of 93% showed that the instrumented group had a 25% reoperation rate (removal of instrumentation with and without second fusion) compared with a reoperation rate of 14% in the noninstrumented group (fusion and decompression) (P < 0.03). A total of 51% were capable of working after 5 years compared with 40% before surgery. There was no difference in work capacity between the two groups at any point of observation. Overall, there was no significant difference between the instrumented and noninstrumented groups in regard to functional outcome as measured by both the Dallas Pain Questionnaire and Low Back Pain Rating Scale. When analyzing diagnostic subgroups at the 5-year follow-up, patients with isthmic spondylolisthesis had a significantly better outcome by use of a posterolateral fusion without supplemental instrumentation compared with an instrumented fusion (P < 0.03). However, patients with primary degenerative instability improved significantly more when instrumentation supported the posterolateral spinal fusions (P < 0.02). To the question “was it worth it?” 67% answered “yes” in the instrumented group whereas 70% did so in the noninstrumented groups (not significant). Conclusion. The long-term functional outcome of posterolateral spinal fusion improved significantly for boththose with and without pedicle screw instrumentation, with a global 70% satisfaction reported by the patients. Patients with isthmic spondylolisthesis Grades 1 and 2 with noninstrumented fusion had superior long-term outcomes after posterolateral spinal fusion in comparison with an instrumented fusion. In contrast, patients diagnosed as having primary degenerative instability improved significantly when the posterolateral fusion was supported by instrumentation. In actuality, pedicle screw instrumentation increased reoperation rate compared with noninstrumented posterolateral fusion.

Smoking as a Predictor of Negative Outcome in Lumbar Spinal Fusion

Study Design. A review of the smoking habits in 426 patients who had been followed prospectively for 2 years after a lumbar spinal fusion procedure was conducted. Objective. To analyze the effect of pre- and postoperative smoking on clinical and functional outcome after lumbar spinal fusion. Summary of Background Data. Several animal models have shown a negative effect of nicotine on spinal fusion. At this writing, the clinical effect of nicotine on spinal fusion has not been fully clarified. Methods. The study comprised 426 patients who underwent lumbar spinal fusion between 1993 and 1997. These patients received a mailed questionnaire regarding their tobacco consumption before and after their surgery. All other data, including preoperative clinical and functional status, were collected prospectively during a 2-year follow-up period. To assess functional outcome, the Dallas Pain Questionnaire was used. Results. The questionnaire was answered by 396 patients (93%). Of these patients, 54.5% (20% more than the background population) were smokers before the operation. Smoking of more than 10 cigarettes daily before the operation and attempted fusion at two or more levels increased the risk of nonunion: odds ratio, 2.01 (P < 0.016) and odds ratio, 3.03 (P < 0.001), respectively. Smoking cessation increased fusion rates to near those of nonsmokers. Smoking had no influence on functional outcome, as assessed by the Dallas Pain Questionnaire, but preoperative smoking predicted a negative answer to the question “Would you undergo the same treatment again, now that you know the result?” (odds ratio, 1.65;P < 0.054). Conclusions. Smoking was shown to have a negative effect on fusion and overall patient satisfaction, but no measurable influence on the functional outcome as assessed by the Dallas Pain Questionnaire.

Migration of hydroxyapatite coated femoral prostheses. A Roentgen Stereophotogrammetric study

We allocated randomly 27 patients undergoing 28 primary uncemented total hip replacements (THR) to receive prosthetic components of similar design with either plasma-sprayed titanium alloy (Ti) coating (n = 13) or hydroxyapatite (HA) coating (n = 15). After some exclusions, 15 of the patients (15 THR; 7 with HA- and 8 with Ti-coating) were followed by roentgen stereophotogrammetric analysis at 3, 6 and 12 months to measure migration of the femoral component. Twenty-six of the patients (26 THR) were followed clinically and by conventional radiography. All the femoral components had migrated at 3 months. From 3 to 12 months, the migration of Ti-coated components continued whereas the HA-coated components had stabilised. At 12 months there was significantly less migration of the HA-coated components (p < 0.05). The maximum subsidence was 0.2 mm in both groups. The Harris hip score was equal in the two groups preoperatively but at follow-up it was better in the HA-coated group (p < 0.05) and visual analogue scale scores showed that they had less pain (p < 0.05).

Recombinant human vascular endothelial growth factor enhances bone healing in an experimental nonunion model

The re-establishment of vascularity is an early event in fracture healing; upregulation of angiogenesis may therefore promote the formation of bone. We have investigated the capacity of vascular endothelial growth factor (VEGF) to stimulate the formation of bone in an experimental atrophic nonunion model. Three groups of eight rabbits underwent a standard nonunion operation. This was followed by interfragmentary deposition of 100 microg VEGF, carrier alone or autograft. After seven weeks, torsional failure tests and callus size confirmed that VEGF-treated osteotomies had united whereas the carrier-treated osteotomies failed to unite. The biomechanical properties of the groups treated with VEGF and autograft were identical. There was no difference in bone blood flow. We considered that VEGF stimulated the formation of competent bone in an environment deprived of its normal vascularisation and osteoprogenitor cell supply. It could be used to enhance the healing of fractures predisposed to nonunion.

Recombinant bone morphogenetic protein-7 as an intracorporal bone growth stimulator in unstable thoracolumbar burst fractures in humans: preliminary results.

Abstract The study presented here is a pilot study in five patients with unstable thoracolumbar spine fractures treated with transpedicular OP-1 transplantation, short segment instrumentation and posterolateral fusion. Recombinant bone morphogenetic protein-7 in combination with a collagen carrier, also referred to as OP-1, has demonstrated ability to induce healing in long-bone segmental defects in dogs, rabbits and monkeys and to induce successful posterolateral spinal fusion in dogs without need for autogenous bone graft. Furthermore OP-1 has been demonstrated to be effective as a bone graft substitute when performing the PLIF maneuver in a sheep model. Five patients with single-level unstable burst fracture and no neurological impairment were treated with intracorporal OP-1 transplantation, posterior fixation (USS) and posterolateral fusion. One patient with osteomalacia and an L2 burst fracture had an additional intracorporal transplantation performed proximal to the instrumented segment, i.e. OP-1 into T 12 and autogenous bone into T 11. Follow-up time was 12–18 months. On serial radiographs, Cobb and kyphotic angles, as well as anterior, middle and posterior column heights, were measured. Serial CT scans were performed to determine the bone mineral density at fracture level.In one case, radiographic and CT evaluation after 3 and 6 months showed severe resorption at the site of transplantation, but after 12 months, new bone had started to fill in at the area of resorption. In all cases there was loss of correction with regard to anterior and middle column height and sagittal balance at the latest follow-up. These preliminary results regarding OP-1 as a bone graft substitute and stimulator of new bone formation have been disappointing, as the OP-1 device in this study was not capable of inducing an early sufficient structural bone support. There are indications to suggest that OP-1 application to a fracture site in humans might result in detrimental enhanced bone resorption as a primary event.

Circumferential Fusion Improves Outcome in Comparison With Instrumented Posterolateral Fusion : Long-term Results of a Randomized Clinical Trial

Study Design. Prospective randomized clinical study with a 5- to 9-year follow-up period. Objective. The aim of the present study was to analyze the long-term outcome with respect to functional disability, pain, and general health of patients treated by means of circumferential lumbar fusion in comparison with those treated by means of instrumented posterolateral lumbar fusion. Summary of Background Data. Circumferential fusion has become a common procedure in lumbar spinal fusion both as a primary and salvage procedure. However, the claimed advantages of circumferential fusion over conventional posterolateral fusion lack scientific documentation. (The primary report with a 2-year follow-up has been published in Spine in 2002.) Methods. From April 1996 to November 1999, a total of 148 patients (mean age, 45 years) with severe chronic low back pain were randomly selected for either posterolateral lumbar fusion (titanium Cotrel-Dubousset) or circumferential lumbar fusion (instrumented posterolateral fusion with anterior intervertebral support by a Brantigan cage). The primary outcome measure was the Dallas Pain Questionnaire (DPQ). The secondary outcome measures were the Oswestry Disability Index, the SF-36 instrument, and the Low Back Pain Rating Scale. All measures assessed the endpoint outcomes at 5 to 9 years after surgery. Results. The available response rate was 93%. The circumferential group showed a significantly better improvement (P < 0.05) in comparison with the posterolateral group with respect to all four DPQ categories: daily activities, work/leisure, anxiety/depression, and social interest. The Oswestry Disability Index supported these results (P < 0.01). General health, as assessed by means of the SF-36, also showed significantly better physical health (P < 0.01) in the circumferential group, whereas no significant difference was found with respect to mental health compared with the posterolateral group. The circumferential group experienced significantly less back pain (P < 0.05) in comparison with the posterolateral group. In regard to leg pain, no significant difference was found. Conclusion. Circumferential lumbar fusion demands more extensive operative resources compared with posterolateral lumbar fusion. However, 5 to 9 years after surgery, the circumferentially fused patients had a significantly improved outcome compared with those treated by means of posterolateral fusion. These new results not only emphasize the superiority of circumferential fusion in the complex pathology of the lumbar spine but are also strongly supported in all of the validated questionnaires used in the study.

Gap healing enhanced by hydroxyapatite coating in dogs.

During prosthetic implantation, gaps between the implant surface and the surrounding bone may occur resulting in reduced implant stability. In these instances bone-conductive materials might augment the formation of hosting bone into the pores of the implant and insure earlier implant stabilization and fixation by bony ingrowth. Titanium-alloy cylinders with a porous-titanium-alloy plasma spray coating were implanted into the medial femoral condyles in six mature dogs. In another group of six dogs, matched in age, weight, and gender, hydroxyapatite (HA) coated implants were used. All implants were surrounded by a 1-mm gap. Unilateral osteopenia of the knee, with a 20% reduction of bone density as judged by computed tomography scanning, was induced by 12 weekly intraarticular injections of carrageenin into the right knee before surgery. Four weeks after implantation, the HA-coated implants were compared to the parent porous-titanium implants by mechanical testing and histomorphometry. A marked positive influence of HA coating on bone mineralization and the strength of the interfacial bone between the bone and implant was found. The increment in interface shear strength and shear stiffness was three- to fivefold in osteopenic bone and two-fold in control bone. Coating of an unloaded porous-titanium-coated implant with HA accelerates the rate of bone ingrowth and thereby provides relatively high, early interfacial shear strengths in the presence of an initial gap between bone and implant even in the presence of osteopenic host bone.

Effects of locally applied vascular endothelial growth factor (VEGF) and VEGF-inhibitor to the rabbit tibia during distraction osteogenesis.

Introduction: Therapeutic angiogenesis, a novel concept in tissue engineering, is neo‐formation of blood vessels in a tissue upon delivery of an angiogenic growth factor to the tissue. We hypothesised that therapeutic angiogenesis could enhance bone formation and challenged the hypothesis in an experimental model of distraction osteogenesis.