New device technologies for subcutaneous fat biopsy.

PURPOSE: Subcutaneous fat biopsy is useful for the evaluation of amyloidosis, environmental contaminants, lipid metabolism, genetic studies and diabetes research. The present study examined new technologies for fat biopsy. METHODS: Subcutaneous fat biopsy in 10 high-risk individuals was randomized to (i) a 10 ml reciprocating procedure device (RPD) mechanical syringe or (ii) a 60 ml vacuum syringe. Outcome measures included pain by the 10 cm Visual Analogue Pain Scale (VAS), adequacy of biopsied tissue, complications and diagnosis. The operator's ability to control syringes was quantitatively measured by the linear displacement method. RESULTS: Both syringes permitted facile aspiration of subcutaneous fat with adequate sample without complications. The mechanical and the vacuum syringes enhanced control of the needle compared to conventional syringes, reducing unintended forward penetration by 75% (3.6 ± 0.5 mm) and 87% (12.0 ± 1.4 mm), respectively (p < 0.0001). Free adipose cells were obtained in abundance as well as columnar biopsies containing intact blood vessels and connective tissue septa permitting precise microhistological examination. One case of primary AL amyloidosis (κ light chain disease) was diagnosed in each group. CONCLUSIONS: Subcutaneous fat biopsy by needle aspiration can be facilely achieved with new aspiration syringe technologies with improved needle control and enhanced patient safety.

A randomized controlled trial evaluating the cost-effectiveness of sonographic guidance for intra-articular injection of the osteoarthritic knee.

OBJECTIVE: The present randomized controlled study investigated whether sonographic needle guidance affected the outcomes of intra-articular injection for osteoarthritis of the knee. METHODS: Ninety-four noneffusive knees with osteoarthritis were randomized to injection by conventional palpation-guided anatomic landmark injection or sonographic image-guided injection enhanced with a 1-handed mechanical (the reciprocating procedure device) syringe. After intra-articular placement and synovial space dilation were confirmed by sonography, a syringe exchange was performed, and 80 mg of triamcinolone acetonide was injected with the second syringe through the indwelling intra-articular needle. Baseline pain, procedural pain, pain at outcome (2 weeks and 6 months), responders, therapeutic duration, reinjection rates, total cost, and cost per responder were determined. RESULTS: Relative to conventional palpation-guided anatomic landmark methods, sonographic guidance for injection of the knee resulted in 48% reduction in procedural pain (P < 0.001), a 42% reduction in pain scores at outcome (P < 0.03), 107% increase in the responder rate (P < 0.001), 52% reduction in the nonresponder rate (P < 0.001), a 36% increase in therapeutic duration (P = 0.01), a 13% reduction ($17) in cost per patient per year, and a 58% ($224) reduction in cost per responder per year for a hospital outpatient (P < 0.001). CONCLUSIONS: Sonographic needle guidance reduced procedural pain and improved the clinical outcomes and cost-effectiveness of intra-articular injections of the osteoarthritic knee.

Safety syringes and anti-needlestick devices in orthopaedic surgery.

BACKGROUND: The American Academy of Orthopaedic Surgery (AAOS), The Joint Commission, the Occupational Safety and Health Administration (OSHA), and the Needlestick Safety and Prevention Act encourage the integration of safety-engineered devices to prevent needlestick injuries to health-care workers and patients. We hypothesized that safety syringes and needles could be used in outpatient orthopaedic injection and aspiration procedures. METHODS: The study investigated the orthopaedic uses and procedural idiosyncrasies of safety-engineered devices, including (1) four safety needles (Eclipse, SafetyGlide, SurGuard, and Magellan), (2) a mechanical safety syringe (RPD), (3) two automatic retractable syringes (Integra, VanishPoint), (4) three manual retractable syringes (Procedur-SF, Baksnap, Invirosnap), and (5) three shielded syringes (Safety-Lok, Monoject, and Digitally Activated Shielded [DAS] Syringe). The devices were first tested ex vivo, and then 1300 devices were used for 425 subjects undergoing outpatient arthrocentesis, intra-articular injections, local anesthesia, aspiration biopsy, and ultrasound-guided procedures. RESULTS: During the clinical observation, there were no accidental needlesticks (0 needlesticks per 1300 devices). Safety needles could be successfully used on a Luer syringe but were limited to ≤1.5 in (≤3.81 cm) in length and the shield could interfere with sonography. The mechanical safety syringes functioned well in all orthopaedic procedures. Automatic retractable syringes were too small for arthrocentesis of the knee, and the plunger blew out and prematurely collapsed with high-pressure injections. The manual retractable syringes and shielded syringes could be used with conventional needles for most orthopaedic procedures. CONCLUSIONS: The most effective and reliable safety devices for orthopaedic syringe procedures are shielded safety needles, mechanical syringes, manual retractable syringes, and shielded syringes, but not automatic retractable syringes. Even when adopting safety-engineered devices for an orthopaedic clinic, conventional syringes larger than 20 mL and conventional needles longer than 1.5 in (3.8 cm) are necessary.

A randomized, controlled trial of the reciprocating procedure device for local anesthesia.

The purpose of this study was to determine whether the new reciprocating procedure device (RPD) is superior to the conventional syringe for the administration of local anesthesia. There were 209 local lidocaine anesthesia procedures randomized between the RDP and the conventional syringe. Outcome measures included administration time, anesthesia pain, procedure pain, and operator satisfaction. The RPD significantly reduced anesthesia administration time by 49% (RPD: 0.68 +/- 0.59 min, Syringe: 1.32 +/- 1.01 min, p < 0.001, 95% confidence interval [CI] for % reduction: 36%-60%), reduced anesthesia pain by 27% (RPD visual analog pain scale score: 4.05 +/- 2.64; Syringe: 5.55 +/- 3.00; p < 0.001, 95% CI 14%-38%), reduced significant procedure pain by 74% (p < 0.001, 95% CI 60%-87%), and improved physician satisfaction by 63% (p < 0.001, 95% CI 53%-74%). The RPD markedly reduces the pain associated with lidocaine anesthesia administration, reduces administration time, and maintains the effectiveness of local anesthesia. The RPD is superior to and significantly more effective than the conventional syringe for the administration of local lidocaine anesthesia.

Reduced pain of intraarticular hyaluronate injection with the reciprocating procedure device.

BACKGROUND: Greater than 50% of patients report significant pain with intraarticular injection of hyaluronate. The reciprocating procedure device (RPD), also known the reciprocating syringe, has 2 plungers that reciprocate with each other, permitting one-handed operation. The RPD increases physician control of the needle and is proposed to reduce patient pain during syringe procedures. OBJECTIVES: To determine in a randomized controlled trial whether the RPD induces less pain than the traditional syringe during intraarticular hyaluronate therapy for the knee. METHODS: Eighty intraarticular injection procedures of the knee were randomized to either the conventional syringe or the RPD using hyaluronate sodium derivative (Hylan G-F-20). Outcome measures included physician's estimate of pain, patient pain (Visual Analogue Pain Scale [VAPS]), procedure duration, operator satisfaction, complications, and response to the injected medication. RESULTS: Patients reported 85% more pain than physicians estimated. Fifty-one percent (19/37) of subjects experienced moderate to severe pain with the conventional syringe, while only 14% (6/43) experienced pain with the RPD. The RPD reduced pain scores (RPD VAPS score: 2.12 +/- 2.15; conventional syringe VAPS score: 4.22 +/- 3.25; P < 0.001), reduced procedure time (RPD: 1.34 +/- 1.09, conventional syringe: 1.90 +/- 1.35 minutes, P < 0.001), and improved physician satisfaction (RPD VASS Score: 9.02 +/- 0.80, conventional syringe 5.69 +/- 1.33, P < 0.001). CONCLUSIONS: Patients have considerably more pain with intraarticular needle introduction and injectable hyaluronate therapy than physicians estimate. The RPD reduces patient pain, reduces procedure time, and improves needle introduction compared with the conventional syringe for hyaluronate injection therapy for the knee.

A randomized controlled trial of the reciprocating procedure device for intraarticular injection of corticosteroid.

OBJECTIVE: Injection of intraarticular corticosteroid remains an important therapy for inflammatory arthritis. In a randomized controlled trial we compared the new reciprocating procedure device (RPD) to the traditional syringe for injection of intraarticular corticosteroid. METHODS: One hundred fifty-four intraarticular corticosteroid injection procedures were randomized to the conventional syringe or the RPD. Using the syringe or RPD, the needle was introduced into the joint, any effusion that was present was aspirated, and the corticosteroid (methylprednisolone acetate) was injected. Outcome measures included patient pain measured by visual analog scale (VAS pain), procedure duration, operator satisfaction, complications, and immediate and delayed response to the injected medication. RESULTS: The RPD reduced pain scores by 49% (RPD VAS pain score: 2.40 +/- 2.17; conventional syringe VAS pain score: 4.73 +/- 3.39; p < 0.001), reduced procedure time by 31% (RPD: 1.28 +/- 1.08 min, conventional syringe: 1.86 +/- 1.26; p < 0.01), and improved physician satisfaction with the joint procedure device by 63% (RPD visual analog satisfaction scale score: 9.12 +/- 0.80, conventional syringe 5.59 +/- 1.28; p < 0.001). Fifty-five percent (43/78) of patients experienced moderate to severe pain (VAS pain > or = 5) with the conventional syringe, while 17% (13/76) experienced moderate to severe pain with the RPD. The same beneficial response was present when intermediate or large joints were analyzed separately. Longterm outcomes were equivalent. CONCLUSION: When a conventional syringe is used for corticosteroid injection, many patients experience significant procedural pain. The RPD significantly reduces patient pain, reduces procedure time, and improves operator satisfaction. The RPD is superior to the traditional syringe for injection of intraarticular corticosteroid.

Control and performance characteristics of eight different suction biopsy devices.

PURPOSE: To determine the control and performance characteristics of eight different suction biopsy devices. MATERIALS AND METHODS: Physician control of the syringe and needle was measured precisely with the validated linear displacement method during the aspiration phase and during five biopsy passes. The visual analog scale was used to measure operator difficulty in the following domains: (i) attachment to the needle, (ii) generation of vacuum, (iii) detection of loss of vacuum, (iv) release of the vacuum, and (v) clearing of the sample from the needle. RESULTS: Performance in various phases of the biopsy procedure varied widely among the biopsy devices tested. Unintended forward penetration (ie, loss of control in the forward direction) was significant with the reverse aspiration syringe (31.5 +/- 1.7 mm), three-ringed control syringe (25.4 +/- 4.1 mm), BioSuc-C7 syringe (28.3 +/- 1.9 mm), conventional syringe with a plunger lock (6.1 +/- 1.5 mm), syringe pistol (9.2 +/- 2.4 mm), and conventional syringe (3.8 +/- 2.9 mm) but was significantly less for the reciprocating procedure device (RPD; 0.7 +/- 0.7 mm; P