nitinol and Pain

We sought to compare VeraCept (VC175), a novel nitinol intrauterine contraceptive (IUC) with 175 square-mm of copper surface area, to a copper T380S IUC.. We enrolled parous women into a randomized subject-blinded comparison of VC175 and a copper T380S in a 2:1 fashion at a single clinic. The primary outcomes were total adverse events and continuation at 12 months. We also examined pain on insertion, ease of placement, expulsion, tolerability and pregnancy. Subjective ratings were on a 5-point Likert scale (0, no pain to 5, worst pain). We followed subjects through 24-month follow-up.. We enrolled 300 women with 199 randomized to VC175 and 101 to the T380S. Insertion was successful in 198 subjects for VC175 and 100 for the T380S. Mean age was 25 years (range 18, 41), and median parity was 2 (range 1, 8), with 39% having only had Cesarean deliveries. No subjects developed clinical infection or reported serious adverse events. In the VC175 and T380S groups, mean pain at insertion was 1.4 and 2.4, respectively (p<.01). At the 12-month primary endpoint for VC175 and T380S, respectively, continuation was 84% and 68% (p<.002) with expulsions in 5.0% and 12.0% (p<.05) and removal for pain/bleeding in 3.5% and 17.0% (p<.01). At the 24-month visit for VC175 and T380S, respectively, continuation was 77% and 62% (p<.02 by log-rank). One ectopic pregnancy was identified at the 12-month follow-up in a VC175 user. No other pregnancies were diagnosed. With 297.3 and 132.4 woman-years, pregnancy rates were 0.3 and 0.0 per 100 woman-years for VC175 and T380S, respectively.. VC175 resulted in less pain at insertion, fewer expulsions and higher total continuation than the T380S, with similar contraceptive efficacy.. VC175 is a promising new intrauterine copper contraceptive on a nitinol frame that warrants further clinical trials.

Topics: Adolescent; Adult; Alloys; Contraception; Female; Humans; Intrauterine Device Expulsion; Intrauterine Devices, Copper; Pain; Pain Measurement; Parity; Patient Satisfaction; Pregnancy; Young Adult

To clinically evaluate the pain intensity during the week following initial placement of three different orthodontic aligning archwires.. A consecutive sample of 75 patients requiring upper and lower fixed orthodontic appliances were alternately allocated into three different archwires (0.014-inch superelastic NiTi, 0.014-inch thermoelastic NiTi or 0.014-inch conventional NiTi). Assessments of pain/discomfort were made on a daily basis over the first 7-day period after bonding by means of visual analog scale and consumption of analgesics. The maximum pain score was recorded. The possible associations between age, gender, degree of crowding, and teeth irregularity and the pain intensity were also examined. Demographic and clinical differences between the three groups were compared with chi-square test or analysis of variance (ANOVA) test.. No statistically significant differences were found in the pain intensity when the three aligning NiTi archwires were compared (P  =  .63). No significant differences in pain perception were found in terms of gender, age, lower arch crowding, and incisor irregularity. The intake of analgesics was the least in the superelastic NiTi group.. The three forms of NiTi wires were similar in terms of pain intensity during the initial aligning stage of orthodontic fixed appliance therapy. Gender, age, and the degree of crowding have no effect on the perceived discomfort experienced by patients undergoing fixed orthodontic treatment.

Topics: Alloys; Dental Alloys; Double-Blind Method; Female; Humans; Male; Malocclusion; Orthodontic Wires; Pain; Pain Measurement; Prospective Studies; Young Adult

Self-expanding metal stents are a promising alternative in the palliation of malignant esophageal obstruction, but the relative value of different stent types is not well established.. During a 3-year enrollment period in four different centers, 82 consecutive patients with malignant dysphagia without tumor recurrence after surgery or esophagorespiratory fistulas received either an uncovered Wallstent (44 patients) or a knitted nitinol stent (38 patients).. Age (median: 79 yr), sex (F:M = 33:67), dysphagia score (median: 3), Karnofsky score (median: 53), body mass index (median: 19), type of pretreatment, tumor stage, stricture length (median: 5.4 cm), and stricture location were comparable in both stent groups. After stent placement, median dysphagia score improved markedly in both groups by two points. Procedure-related mortality (16 vs 0%; p < 0.01), early complication rate (32 vs 8%; p < 0.01), and severe persistent pain after stent placement (23 vs 0%; p < 0.002) were higher in the Wallstent compared with the knitted nitinol stent group. In contrast, stent dysfunction (7 vs 32%; p < 0.005), reintervention rate (9 vs 34%; p < 0.005), and costs were lower in the Wallstent compared with the nitinol stent group.. In malignant esophageal obstruction, both stents markedly improved dysphagia. Uncovered Wallstents seem to cause more early severe complications than knitted nitinol stents. In contrast, stent dysfunction, reintervention rate, and costs appear to be higher in the nitinol stent group.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Body Mass Index; Costs and Cost Analysis; Deglutition Disorders; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Karnofsky Performance Status; Male; Middle Aged; Neoplasm Staging; Pain; Palliative Care; Retreatment; Stents; Surface Properties; Survival Rate

Thermoreactive nitinol Flexigrip has been developed to ensure better fixation than conventional wire closure. To verify the advantage of Flexigrip over the conventional wiring, we compared early sternal bone healing on computed tomography (CT).. A prospective cohort study enrolled the first consecutive 80 patients with wiring and the second consecutive 44 patients undergoing Flexigrip sternal closure. The primary endpoint was sternal healing evaluated quantitatively using a 6-point scale and measured gaps/offsets of the sternal halves at 6 levels on CT scans on the 14th postoperative day. Secondary endpoints included pain scores and sternal complications 1 month after surgery.. Compared with the patients of wiring, those who received Flexigrips showed higher 6-point scores at most sternum levels, less frequent gaps (52% vs 70%, p = 0.04), lower offsets (3.3 ± 0.9 mm vs 4.3 ± 0.7 mm, p <0.001) at the manubrium, and less frequent gaps (25% vs 43%, p = 0.04) and offsets (2.3% vs 24%, p = 0.002) at the middle of sternum. The pain scores and sternal complication rates were similar between both groups.. CT evaluation 2 weeks after surgery revealed that Flexigrip sternal closure showed less gaps and offsets of the sternal halves, suggesting faster sternal bone union when compared to the wiring.

Topics: Bone Wires; Humans; Pain; Prospective Studies; Sternotomy; Sternum; Surgical Wound Dehiscence; Treatment Outcome

Optimal orthodontic force results in maximum rate of tooth movement without tissue damage. Even though starting orthodontic treatment with a thicker archwire may shorten treatment duration, the evidence on the effect of using 0.018-inch NiTi as the first alignment archwire on pulpal blood flow (PBF) status is still scarce.. to record PBF changes and pain scores associated with using 0.018-inch NiTi as the first alignment archwire during fixed orthodontic treatment.. Patients were selected from subjects attending postgraduate orthodontic teaching clinics at Jordan University of Science and Technology. In total, forty healthy patients who exhibited mild lower arch crowding were included. A split-mouth trial design was used. Each patient received two archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch. Patients were assigned into one of two groups based on archwire sizes used. Group 1: 0.014-inch and 0.018-inch NiTi (Six males, 14 females aged 19.4±1.33 years) and Group 2: 0.016-inch and 0.018-inch NiTi (Seven males, 13 females aged 19.6±1.45 years). The archwire size group was randomly allocated with a 1:1 allocation ratio. A Laser Doppler Flowmeter was used to measure PBF at different time intervals (T0-T5). Pain scores were recorded using a visual analogue scale (VAS). A repeated measures ANOVA and a post-hoc Bonferroni comparison tests were conducted to examine differences at the different time points before and during orthodontic alignment.. For all studied archwire sizes, PBF decreased 20 minutes after their placement. Most PBF changes occurred within 24hours and continued to decrease until 72 hours after archwire placement where the maximum reduction was reached. Eventually, normal values were reverted within 1 month. PBF changes were similar between all alignment - groups.. Initial orthodontic alignment with 0.018-inch NiTi does not cause irreversible changes to pulpal vasculature or produces higher pain scores.

Topics: Alloys; Humans; Orthodontic Wires; Pain; Prospective Studies

Percutaneous transluminal angioplasty (PTA) with stent deployment of infrapopliteal arteries is an accepted but unproven therapy for patients with critical limb ischemia (CLI). We evaluated the safety and effectiveness of the Xpert™ self-expanding nitinol stent (Abbott Vascular, Redwood City, CA) in Rutherford Class 4-6 subjects with infrapopliteal lesions of 4-15 cm in length.. 120 patients (140 limbs, 212 implanted devices) underwent primary infrapopliteal nitinol stent deployment as part of this multicenter registry. The primary endpoint was 12-month amputation-free survival (AFS); secondary endpoints included limb salvage, target lesion revascularization (TLR), 6- month angiographic patency, and 6- and 12-month outcomes of wound healing and pain relief. Despite a 6-month binary stent restenosis rate of 68.5%, the 12-month AFS rate was 78.3%. Stratified according to baseline Rutherford classes 4, 5 and 6, the 12-month AFS rates were 100%, 77.3%, and 55.2%, respectively, and freedom from major amputation rates were 100%, 90.9%, and 70.1%, respectively. The 12-month freedom from major amputation rate and clinically driven TLR were 89.6% and 70.1%, respectively. The 6- and 12-month complete wound-healing rates were 49.0% and 54.4%, respectively. Rutherford class 4 patients had significant pain relief through 12-months (P<0.05).. Primary infrapopliteal nitinol stenting to treat CLI is safe and effective in improving 6-and 12-month clinical outcomes.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Constriction, Pathologic; Critical Illness; Female; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Pain; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Stents; Time Factors; Treatment Outcome; United States; Vascular Patency; Wound Healing

Hysteroscopic permanent tubal sterilization has recently been introduced, resulting in a non-invasive, safe and effective technique. The aim of this study was to assess the feasibility of outpatient hysteroscopic tubal sterilization using a nitinol-dacron intratubal device without anaesthesia and to assess patient procedure compliance.. We untertook a prospective study of 36 consecutive cases of outpatient hysteroscopic tubal sterilization using a nitinol-dacron intratubal device without anaesthesia. Tubal sterilization was performed by placing the device with the aid of a 5.2-mm continuous-flow operative hysteroscope. At the end of the procedure women were asked to rate the pain experienced on a visual analogue scale (VAS) (0, no discomfort to 100, severe discomfort). Successful device placement was assessed after 3 months by hysterosalpingography and diagnostic hysteroscopy.. Successful bilateral placement was obtained in 32 patients (88.9%); in one (2.8%) the placement was monolateral; and in three (8.3%) the procedure failed. Mean operating time was 8.6 +/- 5.3 min. A mean VAS of 36.1 +/- 23.9 was recorded.. The nitinol-dacron intratubal device is safe, appears to be effective long-term, is non-invasive and can be used in the outpatient setting without anaesthesia. Low-level discomfort was experienced by the patients. Limitations of its use include that it is not effective immediately, it is irreversible, it requires special equipment and training, and it is difficult to use in cases of uterine anomalies. We conclude that this method may be offered to all woman asking for permanent tubal sterilization, particularly those who refuse or have contraindications for anaesthesia.

Topics: Adult; Alloys; Anesthesia; Equipment Design; Female; Humans; Hysteroscopy; Middle Aged; Outpatients; Pain; Pain Measurement; Patient Compliance; Patient Satisfaction; Polyethylene Terephthalates; Prospective Studies; Sterilization, Tubal; Time Factors; Treatment Outcome

Serial dilatation, the mainstay of benign 'neopharyngeal' stricture management, can have inconsistent results. Nitinol stents, as a metallic self-expanding coil, may have a role in such patients. Such stents were inserted in four patients but two had to be removed because of intractable pain. It is concluded that nitinol stents are unlikely to have a significant role in the management of neopharyngeal stricture management.

Topics: Aged; Alloys; Constriction, Pathologic; Device Removal; Dilatation; Female; Humans; Laryngeal Neoplasms; Laryngectomy; Male; Middle Aged; Pain; Pharyngeal Diseases; Postoperative Care; Quality of Life; Radiotherapy, Adjuvant; Recurrence; Reoperation; Stents; Treatment Failure