Novel radiopaque ultrahigh molecular weight polyethylene sublaminar wires in a growth-guidance system for the treatment of early-onset scoliosis:feasibility in a large animal study

\u3cp\u3eSTUDY DESIGN. In vivo analysis in an ovine model. OBJECTIVE. To evaluate the feasibility of radiopaque ultrahigh molecular weight polyethylene (UHMWPE) sublaminar wires in a growth-guidance spinal system by assessing stability, biocompatibility, and growth potential. SUMMARY OF BACKGROUND DATA. Several growth-guidance systems have been developed for the treatment of early-onset scoliosis. The use of gliding pedicle screws and metal sublaminar wires during these procedures can cause metal-on-metal debris formation and neurological deficits. Novel radiopaque UHMWPE wires are introduced to safely facilitate longitudinal growth and provide stability in a growth-guidance system for early-onset scoliosis. METHODS. Twelve immature sheep received posterior segmental spinal instrumentation; pedicle screws were inserted at L5 and radiopaque UHMWPE (bismuth trioxide) wires were passed sublaminarly at each level between L3 and T12 and fixed to dual cobalt-chromium rods. Four age-matched animals that were not operated were evaluated to serve as a control group. Radiographs were obtained to measure growth of the instrumented segment. After 24 weeks, the animals were killed and the spines were harvested for histological evaluation and high-resolution peripheral quantitative computed tomographic analysis. RESULTS. No neurological deficits occurred and all instrumentation remained stable. One animal died from an unknown cause. Substantial growth occurred in the instrumented segments (L5-T11) in the intervention group (27 ± 2 mm), which was not significantly different to the control group, (30 ± 4 mm, P = 0.42). High-resolution peripheral quantitative computed tomographic analysis clearly showed safe routing and fixation of the UHMWPE wires and instrumentation. Despite the noted growth, ectopic bone formation with the formation of bony bridges was observed in all animals. Histology revealed no evidence of chronic inflammation or wear debris. CONCLUSION. This study shows the first results of radiopaque UHMWPE sublaminar wires as part of a growth-guidance spinal system. UHMWPE sublaminar wires facilitated near-normal longitudinal spinal growth. All instrumentation remained stable throughout follow-up; no wire breakage or loosening occurred and no adverse local-tissue response to these wires was observed. Level of Evidence: N/A.\u3c/p\u3

Distal radius plate of CFR-PEEK has minimal effect compared to titanium plates on bone parameters in high-resolution peripheral quantitative computed tomography: a pilot study

\u3cp\u3eBACKGROUND: Carbon-fiber-reinforced poly-ether-ether-ketone (CFR-PEEK) has superior radiolucency compared to other orthopedic implant materials, e.g. titanium or stainless steel, thus allowing metal-artifact-free postoperative monitoring by computed tomography (CT). Recently, high-resolution peripheral quantitative CT (HRpQCT) proved to be a promising technique to monitor the recovery of volumetric bone mineral density (vBMD), micro-architecture and biomechanical parameters in stable conservatively treated distal radius fractures. When using HRpQCT to monitor unstable distal radius fractures that require volar distal radius plating for fixation, radiolucent CFR-PEEK plates may be a better alternative to currently used titanium plates to allow for reliable assessment. In this pilot study, we assessed the effect of a volar distal radius plate made from CFR-PEEK on bone parameters obtained from HRpQCT in comparison to two titanium plates.\u3c/p\u3e\u3cp\u3eMETHODS: Plates were instrumented in separate cadaveric human fore-arms (n = 3). After instrumentation and after removal of the plates duplicate HRpQCT scans were made of the region covered by the plate. HRpQCT images were visually checked for artifacts. vBMD, micro-architectural and biomechanical parameters were calculated, and compared between the uninstrumented and instrumented radii.\u3c/p\u3e\u3cp\u3eRESULTS: No visible image artifacts were observed in the CFR-PEEK plate instrumented radius, and errors in bone parameters ranged from -3.2 to 2.6%. In the radii instrumented with the titanium plates, severe image artifacts were observed and errors in bone parameters ranged between -30.2 and 67.0%.\u3c/p\u3e\u3cp\u3eCONCLUSIONS: We recommend using CFR-PEEK plates in longitudinal in vivo studies that monitor the healing process of unstable distal radius fractures treated operatively by plating or bone graft ingrowth.\u3c/p\u3

Effect of a cast on short-term reproducibility and bone parameters obtained from HR-pQCT measurements at the distal end of the radius

\u3cp\u3eBACKGROUND: High-resolution peripheral quantitative computed tomography (HR-pQCT) is a promising tool to assess the fracture-healing process at the microscale in vivo. Since casts are often used during fracture treatment, they might affect the assessment of bone density, microarchitectural, and biomechanical parameters and the short-term reproducibility of those parameters, e.g., as a result of beam-hardening. The aim of this study was to assess the effect of a plaster-of-Paris and/or fiberglass cast on bone parameters and on the short-term reproducibility of the HR-pQCT measurements of those parameters.\u3c/p\u3e\u3cp\u3eMETHODS: The effects of a cast on HR-pQCT-derived bone parameters were evaluated by comparing HR-pQCT scans of fifteen human cadaveric distal radial specimens from one male and fourteen female donors (median age, eighty-four years [range, sixty-two to ninety years] at the time of death) in three conditions: with a plaster-of-Paris cast, with a fiberglass cast, or without a cast. Short-term reproducibility was assessed using duplicate scans of the distal end of the radius in sixteen healthy volunteers without a fracture (nine men and seven women with a median age of twenty-six years; range, twenty-two to thirty-nine years) while wearing and not wearing a fiberglass cast.\u3c/p\u3e\u3cp\u3eRESULTS: Compared with measurements made with no cast, the plaster-of-Paris cast introduced a systematic error in the bone parameters ranging from -2.6% in trabecular separation to -9.8% in cortical thickness. Bone parameters were affected only marginally by fiberglass, with errors between -0.6% and -1.6% in trabecular separation and cortical thickness, respectively. Short-term reproducibility with a fiberglass cast was similar to that with no cast: approximately 1% for bone density parameters, 4% to 5% for microarchitectural parameters, and 3% to 4% for biomechanical parameters.\u3c/p\u3e\u3cp\u3eCONCLUSIONS: A plaster-of-Paris cast has a considerable effect on HR-pQCT measurements. A fiberglass cast only marginally affects the bone parameters, and the short-term reproducibility of HR-pQCT measurements in patients with a fiberglass cast is comparable with that in patients without a cast. In studies on fracture-healing using HR-pQCT, a fiberglass cast is desirable if immobilization is indicated. The use of a plaster-of-Paris cast should be avoided if possible; however, if not avoidable, corrections after the scan are desirable to adjust for the error introduced in the bone parameters.\u3c/p\u3

An automated algorithm for the detection of cortical interruptions on high resolution peripheral quantitative computed tomography images of finger joints

\u3cp\u3eOBJECTIVES: To introduce a fully-automated algorithm for the detection of small cortical interruptions (≥0.246mm in diameter) on high resolution peripheral quantitative computed tomography (HR-pQCT) images, and to investigate the additional value of manual correction of the automatically obtained contours (semi-automated procedure).\u3c/p\u3e\u3cp\u3eMETHODS: Ten metacarpophalangeal joints from seven patients with rheumatoid arthritis (RA) and three healthy controls were imaged with HR-pQCT. The images were evaluated by an algorithm according to the fully- and semi-automated procedure for the number and surface of interruptions per joint. Reliability between the fully- and semi-automated procedure and between two independent operators was tested using intra-class correlation coefficient (ICC) and the proportion of matching interruptions. Validity of single interruptions detected was tested by comparing it to visual scoring, as gold standard. The positive predictive value (PPV) and sensitivity were calculated.\u3c/p\u3e\u3cp\u3eRESULTS: The median number of interruptions per joint was 14 (range 2 to 59) and did not significantly differ between the fully- and semi-automated procedure (p = 0.37). The median interruption surface per joint was significantly higher with the fully- vs. semi-automated procedure (respectively, 8.6mm2 vs. 5.8mm2 and 6.1mm2, p = 0.01). Reliability was almost perfect between the fully- and semi-automated procedure for both the number and surface of interruptions (ICC≥0.95) and the proportion of matching interruptions was high (≥76%). Also the inter-operator reliability was almost perfect (ICC≥0.97, proportion of matching interruptions 92%). The PPV ranged from 27.6% to 29.9%, and sensitivity from 69.7% to 76.3%. Most interruptions detected with the algorithm, did show an interruption on a 2D grayscale image. However, this interruption did not meet the criteria of an interruption with visual scoring.\u3c/p\u3e\u3cp\u3eCONCLUSION: The algorithm for HR-pQCT images detects cortical interruptions, and its interruption surface. Reliability and validity was comparable for the fully- and semi-automated procedures. However, we advise the use of the semi-automated procedure to assure quality. The algorithm is a promising tool for a sensitive and objective assessment of cortical interruptions in finger joints assessed by HR-pQCT.\u3c/p\u3

Long-term functional outcome of distal radius fractures is associated with early post-fracture bone stiffness of the fracture region:an HR-pQCT exploratory study

\u3cp\u3eIdentifying determinants of long-term functional outcome after a distal radius fracture is challenging. Previously, we reported on the association between early HR-pQCT measurements and clinical outcome 12 weeks after a conservatively treated distal radius fracture. We extended the follow-up and assessed functional outcome after two years in relation to early HR-pQCT derived bone parameters. HR-pQCT scans of the fracture region were performed in 15 postmenopausal women with a distal radius fracture at 1-2 (baseline), 3-4 weeks and 26 months post-fracture. Additionally, the contralateral distal radius was scanned at baseline. Bone density, micro-architecture parameters and bone stiffness using micro-finite element analysis (μFEA) were evaluated. During all visits, wrist pain and function were assessed using the patient-rated wrist evaluation questionnaire (PRWE), quantifying functional outcome with a score between 0 and 100. Two-year PRWE was associated with torsional and bending stiffness 3-4 weeks post-fracture (R2: 0.49, p = 0.006 and R2: 0.54, p = 0.003, respectively). In contrast, early micro-architecture parameters of the fracture region or contralateral bone parameters did not show any association with long-term outcome. This exploratory study indicates that HR-pQCT with μFEA performed within four weeks after a distal radius fracture captures biomechanical fracture characteristics that are associated with long-term functional outcome and therefore could be a valuable early outcome measure in clinical trials and clinical practice.\u3c/p\u3

Early changes in bone density, microarchitecture, bone resorption, and inflammation predict the clinical outcome 12 weeks after conservatively treated distal radius fractures : an exploratory study

Fracture healing is an active process with early changes in bone and inflammation. We performed an exploratory study evaluating the association between early changes in densitometric, structural, biomechanical, and biochemical bone parameters during the first weeks of fracture healing and wrist-specific pain and disability at 12 weeks in postmenopausal women with a conservatively treated distal radius fracture. Eighteen patients (aged 64¿±¿8 years) were evaluated at 1 to 2 and 3 to 4 weeks postfracture, using high-resolution peripheral quantitative computed tomography (HR-pQCT), micro-finite element analysis, serum procollagen type-I N-terminal propeptide (P1NP), carboxy-terminal telopeptide of type I collagen (ICTP), and high-sensitive C-reactive protein (hsCRP). After 12 weeks, patients rated their pain and disability using Patient Rated Wrist Evaluation (PRWE) questionnaire. Additionally, Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire and active wrist range of motion was evaluated. Linear regression models were used to study the relationship between changes in bone parameters and in hsCRP from visit 1 to 2 and PRWE score after 12 weeks. A lower PRWE outcome, indicating better outcome, was significantly related to an early increase in trabecular bone mineral density (BMD) (ß -0.96 [95% CI -1.75 to -0.16], R2¿=¿0.37), in torsional stiffness (-0.14 [-0.28 to -0.004], R2¿=¿0.31), and to an early decrease in trabecular separation (209 [15 to 402], R2¿=¿0.33) and in ICTP (12.1 [0.0 to 24.1], R2¿=¿0.34). Similar results were found for QuickDASH. Higher total dorsal and palmar flexion range of motion was significantly related to early increase in hsCRP (9.62 [3.90 to 15.34], R2¿=¿0.52). This exploratory study indicates that the assessment of early changes in trabecular BMD, trabecular separation, calculated torsional stiffness, bone resorption marker ICTP, and hsCRP after a distal radius fracture provides valuable information regarding the 12-week clinical outcome in terms of pain, disability, and range of motion and validates its use in studies on the process of early fracture healing. © 2014 American Society for Bone and Mineral Research

An automated algorithm for the detection of cortical interruptions and its underlying loss of trabecular bone; A reproducibility study

\u3cp\u3eBackground: We developed a semi-automated algorithm that detects cortical interruptions in finger joints using high-resolution peripheral quantitative computed tomography (HR-pQCT), and extended it with trabecular void volume measurement. In this study we tested the reproducibility of the algorithm using scan/re-scan data. Methods: Second and third metacarpophalangeal joints of 21 subjects (mean age 49 (SD 11) years, 17 early rheumatoid arthritis and 4 undifferentiated arthritis, all diagnosed <1 year ago) were imaged twice by HR-pQCT on the same day with repositioning between scans. The images were analyzed twice by one operator (OP1) and once by an additional operator (OP2), who independently corrected the bone contours when necessary. The number, surface and volume of interruptions per joint were obtained. Intra- and inter-operator reliability and intra-operator reproducibility were determined by intra-class correlation coefficients (ICC). Intra-operator reproducibility errors were determined as the least significant change (LSC\u3csub\u3eSD\u3c/sub\u3e). Results: Per joint, the mean number of interruptions was 3.1 (SD 3.6), mean interruption surface 4.2 (SD 7.2) mm\u3csup\u3e2\u3c/sup\u3e, and mean interruption volume 3.5 (SD 10.6) mm\u3csup\u3e3\u3c/sup\u3e for OP1. Intra- and inter-operator reliability was excellent for the cortical interruption parameters (ICC ≥0.91), except good for the inter-operator reliability of the interruption surface (ICC=0.70). The LSC\u3csub\u3eSD\u3c/sub\u3e per joint was 4.2 for the number of interruptions, 5.8 mm\u3csup\u3e2\u3c/sup\u3e for interruption surface, and 3.2 mm\u3csup\u3e3\u3c/sup\u3e for interruption volume. Conclusions: The algorithm was highly reproducible in the detection of cortical interruptions and their volume. Based on the LSC findings, the potential value of this algorithm for monitoring structural damage in the joints in early arthritis patients needs to be tested in clinical studies.\u3c/p\u3

Reliability of HR-pQCT derived cortical bone structural parameters when using uncorrected instead of corrected automatically generated endocortical contours in a cross-sectional study:the Maastricht study

\u3cp\u3eMost HR-pQCT studies examining cortical bone use an automatically generated endocortical contour (AUTO), which is manually corrected if it visually deviates from the apparent endocortical margin (semi-automatic method, S-AUTO). This technique may be prone to operator-related variability and is time consuming. We examined whether the AUTO instead of the S-AUTO method can be used for cortical bone analysis. Fifty scans of the distal radius and tibia from participants of The Maastricht Study were evaluated with AUTO, and subsequently with S-AUTO by three independent operators. AUTO cortical bone parameters were compared to the average parameters obtained by the three operators (S-AUTOmean). All differences in mean cortical bone parameters between AUTO and S-AUTOmean were < 5%, except for lower AUTO cortical porosity of the radius (− 16%) and tibia (− 6%), and cortical pore volume (Ct.Po.V) of the radius (− 7%). The ICC of S-AUTOmean and AUTO was > 0.90 for all parameters, except for cortical pore diameter of the radius (0.79) and tibia (0.74) and Ct.Po.V of the tibia (0.89), without systematic errors on the Bland–Altman plots. The precision errors (RMS-CV%) of the radius parameters between S-AUTOmean and AUTO were comparable to those between the individual operators, whereas the tibia RMS-CV% between S-AUTOmean and AUTO were higher than those of the individual operators. Comparison of the three operators revealed clear inter-operator variability. This study suggests that the AUTO method can be used for cortical bone analysis in a cross-sectional study, but that the absolute values—particularly of the porosity-related parameters—will be lower.\u3c/p\u3