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Background Now, using a suture-button device to treat distal tibiofibular syndesmotic injuries is overwhelming due to its advantages over screw fixation. Current systematic review was conducted to make a comparison between suture-button fixation and traditionally screw fixation in the treatment of syndesmotic injuries. The outcomes included functional outcomes, implant removal, implant failure, malreduction, post-operative complications (except implant failure and malreduction), and cost-effectiveness aspects. Method A literature search in the electronic databases of Medline, Embase, the Cochrane Library, Web of Science was conducted to identify studies until March 2017. The references of the included articles were also checked for potentially relevant studies. Only English articles were included. We followed the Preferred Reporting Items for Systematics reviews and Meta-Analysis (PRISMA) guidelines in this review. Results Finally, 10 studies were identified, encompassing a total of 390 patients. The mean American Orthopaedic Foot and Ankle Society ankle score (AOFAS) score of 150 patients treated with the suture-button device was 91.06 points, with an average follow-up of 17.58 months, and the mean AOFAS score of 150 patients treated with syndesmotic screws was 87.78 points, with an average follow-up of 17.73 months. Implant removal was reported in 5 of 134 (3.7%) patients treated with the suture-button device, and in 54 of 134 (40.2%) patients treated with the syndesmotic screw. No patient in the suture-button fixation group had implant failure, however the rate of implant failure in the screw fixation group was 30.9%. Malreduction was reported in 1 of 93 (1.0%) patients treated with the suture-button device, and in 12 of 95 (12.6%) patients treated with the syndesmotic screw. The rate of post-operative complications in the suture-button fixation group was 12.0% and 16.4% in the screw fixation group. There was only one publication demonstrated about cost-effectiveness aspects, it showed that patients treated with the suture-button device spent on average $1482 less and had a higher quality of life by 0.058 quality-adjusted life-year compared with patients who received fixation with 2 syndesmotic screws in supination-external rotation type 4 injuries. Conclusion Based on our research, though the suture-button fixation group had similar functional outcome (measured on the AOFAS score) and post-operative complication rate compared with the syndesmotic screw fixation group, the suture-button device could lead to better objective range of motion (ROM) measurements and earlier return to work. Besides, the suture-button fixation group had lower rate of implant removal, implant failure, and malreduction. However, high-quality randomized controlled trials with more uniformity in outcome reporting are desirable to determine the long-term effects and cost-effectiveness of the suture-button device.

Background Scaphoid fractures are the most common carpal fractures. They often need to be treated by surgery, where the use of a compression screw is the globally accepted gold standard. Surgeons may choose between different implant materials including titanium alloys, which remain in the body or are removed after healing. An alternative are biodegradable magnesium-based implants. Properties of magnesium alloys include high stability, osteoconductivity, potential reduction of infections and few artifacts in magnetic resonance imaging (MRI). The aim of this trial is to demonstrate non-inferiority of magnesium-based compression screws compared with titanium Herbert screws for scaphoid fractures. Methods The trial is designed as a multicenter, blinded observer, randomized controlled parallel two-group post market trial. Approximately 190 patients will be randomized (1:1) with stratification by center either to titanium or magnesium-based compression screws. Follow-up is 1 year per patient. Surgical procedures and aftercare will be performed according to the German treatment guideline for scaphoid fractures. The first primary endpoint is the patient-rated wrist evaluation (PRWE) score after 6 months. The second primary endpoint is a composite safety endpoint including bone union until 6 months, no adverse device effect (ADE) during surgery or wound healing and no serious ADE or reoperation within 1 year. The third primary endpoint is the difference in change MRI artifacts over time. Non-inferiority will be investigated for primary endpoints 1 (t-test confidence interval) and 2 (Wilson’s score interval) using both the full analysis set (FAS) and the per protocol population at the one-sided 2.5% test-level. Superiority of magnesium over titanium screws will be established using the FAS at the two-sided 5% test-level (Welch test) only if non-inferiority has been established for both primary endpoints. Secondary endpoints include quality of life. Discussion This study will inform care providers whether biodegradable magnesium-based implants are non-inferior to standard titanium Herbert screws for the treatment of scaphoid fractures in terms of wrist function and safety. Furthermore, superiority of magnesium-based implants may be demonstrated using MRI, which is used as surrogate endpoint for screw degradation. Trial registration DRKS, DRKS00013368 . Registered Dec 04, 2017.

Rod failure has been reported clinically in pedicle subtraction osteotomy (PSO) to correct flat back deformity. To characterize the fatigue life of posterior screw-rod constructs in the setting of PSO as a function of the severity of rod contour angle. A modified ASTM F1717 to 04 was used. Rods were contoured to the appropriate angle for the equivalent 20-, 40-, or 60-degree PSO angles. Testing was performed on a mechanical test frame at 400/40 N and 250/25 N, and specimens were cycled at 4 Hz to failure or run-out at 2,000,000 cycles. The effect of the screw-rod system on fatigue strength of curved rods was compared using Cox proportional hazards regression. At 400 N/40 N, Cox proportional hazards regression indicated that contouring rods from a 20-degree PSO angle to either 40 or 60 degrees significantly decreased fatigue life (hazard ratio = 7863.6, P = .0144). However, contouring rods from a 40-degree PSO angle to 60 degrees had no significant effect on the fatigue life (P > .05). At 250 N/25 N, Cox proportional hazards regression indicated that contouring rods from a 20-degree PSO angle to either 40 or 60 degrees significantly decreased fatigue life (hazard ratio = 7863.6, P = .0144). Furthermore, contouring rods from a 40-degree PSO angle to 60 degrees had a significant effect on the fatigue life (hazard ratio = 7863.6, P = .0144). Results suggest that in the setting of PSO, the fatigue life of posterior spinal fixation rods depends largely on the severity of the rod angle used to maintain the vertebral angle created by the PSO and is significantly lowered by rod contouring.

Finite element analysis is commonly used to assist in the development and evaluation of orthopedic devices. The physics of these models are simplified through approximations that enable more efficient simulations, without compromising the accuracy of the relative comparisons between implant designs or configurations. This study developed and evaluated a technique to approximate the behavior of a finely threaded screw using a smooth cylinder with the threads implicitly represented through interfacial contact conditions. This pseudo-threaded model was calibrated by comparing to simulations that explicitly modeled the thread geometry with frictional contact. A parametric analysis was performed with a single screw-in-bone system, five loading directions, and three Young׳s moduli that span the range of cancellous bone (200, 600, and 1,000MPa). Considering that screw cut-out from cancellous bone is a critical clinical issue in the osteoporotic proximal humerus, the pseudo-threaded model was compared with a bonded interface to examine three different screw configurations in a 3-part proximal humerus fracture across 10 patients. In the single screw-in-bone system, the pseudo-threaded model predicted the screw displacement of the explicitly threaded model with 1–5% difference and estimated the strain distributions and magnitudes more accurately than a bonded interface. Yet, the relative comparisons of implant stability across the three different screw configurations in the proximal humerus were not affected by the modeling choice for the bone–screw interface. Therefore, the bonded interface could serve as a more efficient methodology for making relative comparisons between implants that utilize the same thread profile.

The interference screw fixation method is used to secure a graft in the tibial tunnel during anterior cruciate ligament reconstruction surgery. However, several complications have been reported, such as biodegradable screw breakage, inflammatory or foreign body reaction, tunnel enlargement, and delayed graft healing. Using additive manufacturing (AM) technology, we developed a titanium alloy (Ti6Al4V) interference screw with chemically calcium phosphate surface modification technology to improve bone integration in the tibial tunnel. After chemical and heat treatment, the titanium screw formed a dense apatite layer on the metal surface in simulated body fluid. Twenty-seven New Zealand white rabbits were randomly divided into control and additive manufactured (AMD) screw groups. The long digital extensor tendon was detached and translated into a tibial plateau tunnel (diameter: 2.0 mm) and transfixed with an interference screw while the paw was in dorsiflexion. Biomechanical analyses, histological analyses, and an imaging study were performed at 1, 3, and 6 months. The biomechanical test showed that the ultimate pull-out load failure was significantly higher in the AMD screw group in all tested periods. Micro-computed tomography analyses revealed early woven bone formation in the AMD screw group at 1 and 3 months. In conclusion, AMD screws with bioactive surface modification improved bone ingrowth and enhanced biomechanical performance in a rabbit model.

Importance Fractures of the hip have devastating effects on function and quality of life. Intramedullary nails (IMN) are the dominant implant choice for the treatment of trochanteric fractures of the hip. Higher costs of IMNs and inconclusive benefit in comparison with sliding hip screws (SHSs) convey the need for definitive evidence. Objective To compare 1-year outcomes of patients with trochanteric fractures treated with the IMN vs an SHS. Design, Setting, and Participants This randomized clinical trial was conducted at 25 international sites across 12 countries. Participants included ambulatory patients aged 18 years and older with low-energy trochanteric (AO Foundation and Orthopaedic Trauma Association [AO/OTA] type 31-A1 or 31-A2) fractures. Patient recruitment occurred between January 2012 and January 2016, and patients were followed up for 52 weeks (primary end point). Follow-up was completed in January 2017. The analysis was performed in July 2018 and confirmed in January 2022. Interventions Surgical fixation with a Gamma3 IMN or an SHS. Main Outcomes and Measures The primary outcome was health-related quality of life (HRQOL), measured by the EuroQol–5 Dimension (EQ5D) at 1-year postsurgery. Secondary outcomes included revision surgical procedure, fracture healing, adverse events, patient mobility (measured by the Parker mobility score), and hip function (measured by the Harris hip score). Results In this randomized clinical trial, 850 patients were randomized (mean [range] age, 78.5 [18-102] years; 549 [64.6% female) with trochanteric fractures to undergo fixation with either the IMN (n = 423) or an SHS (n = 427). A total of 621 patients completed follow-up at 1 year postsurgery (304 treated with the IMN [71.9%], 317 treated with an SHS [74.2%]). There were no significant differences between groups in EQ5D scores (mean difference, 0.02 points; 95% CI, −0.03 to 0.07 points;P = .42). Furthermore, after adjusting for relevant covariables, there were no between-group differences in EQ5D scores (regression coefficient, 0.00; 95% CI, −0.04 to 0.05;P = .81). There were no between-group differences for any secondary outcomes. There were also no significant interactions for fracture stability (β [SE] , 0.01 [0.05];P = .82) or previous fracture (β [SE], 0.01 [0.10];P = .88) and treatment group. Conclusions and Relevance This randomized clinical trial found that IMNs for the treatment of trochanteric fractures had similar 1-year outcomes compared with SHSs. These results suggest that the SHS is an acceptable lower-cost alternative for trochanteric fractures of the hip. Trial Registration ClinicalTrials.gov Identifier:NCT01380444

Objectives To examine and compare the stability of buccal shelf mini-screws using self-drilling and pre-drilling implant placement techniques. Methodology It was a split-mouth, randomized controlled trial comprising of 7 patients, each receiving two buccal shelf bone screws. The screws were placed using a self-drilling protocol in one quadrant and a pre-drilling protocol in the opposing quadrant decided via coin toss randomization. Stability was examined at the time of placement and 1,2, 3 and 4 months thereafter, using the Resonance Frequency Analysis method with the Osstell Beacon TM device. The Implant Stability Quotient (ISQ) obtained was then compared and assessed between both quadrants. Friedman’s Two-Way Analysis of Variance and the Wilcoxon signed rank test were utilized for the intergroup comparison. A statistically significant result was defined as one with a p-value of less than 0.05. Results A statistically significant difference between the mean ISQ reading in the pre-drilling and self-drilling group was observed, indicating higher stability of bone screws placed with the pre-drilling protocol. The primary stability of the buccal shelf screws decreased after placement, but the secondary stability remained stable. Conclusion Buccal shelf bone screws placed with a pre-drilling protocol depicted greater primary and secondary stability as compared to the self-drilling protocol, as depicted by the ISQ readings obtained. Resonance Frequency Analysis can be used as a valuable tool to assess the stability of buccal shelf bone screws. Clinical relevance The use of buccal shelf screws has increased tremendously over the past few years due to their myriad applications and have now become an essential part of an orthodontist’s armamentarium. It is therefore essential for clinicians to be well-informed about all aspects of their use including insertion techniques. The results of this trial indicate that the pre-drilling protocol provides better stability and therefore treatment outcomes.

Surgery for intertrochanteric fractures using intramedullary hip nails (IHNs) is among the most common surgical procedures in the orthopedic field. Although IHNs provide good overall outcomes, they sometimes cause complications, such as loss of reduction and cut-out. Here, we investigated the usefulness of IHNs with an anterior offset (Best Fit Nail® [BFN]) in maintaining fragment reduction and ensuring proper lag screw position compared with conventional non-offset nails (Proximal Femoral Nail Antirotation® [PFNA]), using postoperative computed tomography (CT). Fifty consecutive patients with intertrochanteric fractures who underwent surgery with BFNs (BFN group) and 50 patients who underwent surgery with PFNAs (PFNA group) were retrospectively analyzed. Indices evaluated by postoperative CT were displacement distance of proximal fragment relative to distal fragment, reduction status (intramedullary, anatomical, and extramedullary types), lag screw direction, and angle between lag screw and femoral neck axis (deviation angle). Median [interquartile range] displacement distance was significantly smaller in the BFN group (0 [0, 0] mm) compared with the PFNA group (5.2 [3.6, 7.1] mm) (p<0.001). Reduction status was significantly better in the BFN group (anatomical type, 40 cases; intramedullary type, in 9 cases, and extramedullary type in 1 case) than in the PFNA group (anatomical type, 6 cases; intramedullary type, 43 cases; extramedullary type, 1 case) (p<0.001). Deviation of lag screw direction was observed in significantly fewer cases in the BFN group (20 cases; 40%) compared with the PFNA group (36 cases; 72%). Lag screw deviation angle was significantly smaller in the BFN group (-0.71°±4.0°) compared with the PFNA group (6.9°±7.1°). No adverse events related to surgery were observed in either group. Intertrochanteric fracture surgery using offset BFNs exhibited significantly smaller displacement distance, better reduction status, and higher frequency of no deviation with central lag screw position, compared with surgery using non-offset PFNAs.

The existence and importance of an accelerated adjacent segment disc degeneration (ASD) after lumbar fusion have previously not been demonstrated by RCTs. The objectives of this study were, to determine whether lumbar fusion in the long term accelerates degenerative changes in the adjacent disc and whether this affects the outcome, by using a prospective randomised design. A total of 111 patients, aged 18–55, with isthmic spondylolisthesis were randomised to exercise (EX, n  = 34) or posterolateral fusion (PLF, n  = 77), with ( n  = 37) or without pedicle screw instrumentation ( n  = 40). The minimum 10 years FU rate was 72%, with a mean FU time of 12.6 years (range 10–17 years). Three radiographic methods of ASD quantification were used, i.e. two digital radiographic measurement methods and the semi quantitative UCLA grading scale. One digital measurement method showed a mean disc height reduction by 2% in the EX group and by 15% in the PLF group ( p  = 0.0016), and the other showed 0.5 mm more disc height reduction in the PLF compared to the Ex group (ns). The UCLA grading scale showed normal discs in 100% of patients in the EX group, compared to 62% in the PLF group ( p  = 0.026). There were no significant differences between instrumented and non-instrumented patients. In patients with laminectomy we found a significantly higher incidence of ASD compared to non laminectomised patients (22/47 vs. 2/16 respectively, p  = 0.015). In the longitudinal analysis, the posterior and anterior disc heights were significantly reduced in the PLF group, whereas in the EX group only the posterior disc height was significantly reduced. Except for global outcome, which was significantly better for patients without ASD, the clinical outcome was not statistically different in patients with and without ASD. In conclusion, the long-term RCT shows that fusion accelerates degenerative changes at the adjacent level compared with natural history. The study suggests that not only fusion, but also laminectomy may be of pathogenetic importance. The clinical importance of ASD seems limited, with only the more severe forms affecting the outcome.

This is an experimental study on human cadaver spines. The objective of this study is to compare the pullout forces between three screw augmentation methods and two different screw designs. Surgical interventions of patients with osteoporosis increase following the epidemiological development. Biomechanically the pedicle provides the strongest screw fixation in healthy bone, whereas in osteoporosis all areas of the vertebra are affected by the disease. This explains the high screw failure rates in those patients. Therefore PMMA augmentation of screws is often mandatory. This study involved investigation of the pullout forces of augmented transpedicular screws in five human lumbar spines (L1–L4). Each spine was treated with four different methods: non-augmented unperforated (solid) screw, perforated screw with vertebroplasty augmentation, solid screw with vertebroplasty augmentation and solid screw with balloon kyphoplasty augmentation. Screws were augmented with Polymethylmethacrylate (PMMA). The pullout forces were measured for each treatment with an Instron testing device. The bone mineral density was measured for each vertebra with Micro-CT. The statistical analysis was performed with a two-sided independent student t test. Forty screws (10 per group and level) were inserted. The vertebroplasty-augmented screws showed a significant higher pullout force (mean 918.5 N, P  = 0.001) than control (mean 51 N), the balloon kyphoplasty group did not improve the pullout force significantly (mean 781 N, P  > 0.05). However, leakage occurred in some cases treated with perforated screws. All spines showed osteoporosis on Micro-CT. Vertebroplasty-augmented screws, augmentation of perforated screws and balloon kyphoplasty augmented screws show higher pullout resistance than non-augmented screws. Significant higher pullout forces were only reached in the vertebroplasty augmented vertebra. The perforated screw design led to epidural leakage due to the position of the perforation in the screw. The position of the most proximal perforation is critical, depending on screw design and proper insertion depth. Nevertheless, using a properly designed perforated screw will facilitate augmentation and instrumentation in osteoporotic spines.