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Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 37 - 37
1 Oct 2019
Nahhas CR Chalmers PN Parvizi J Sporer SM Berend KR Moric M Chen AF Austin M Deirmengian GK Morris MJ Culvern C Valle CJD
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Background

The purpose of this multi-center, randomized clinical trial was to compare static and articulating spacers in the treatment of PJI complicating total knee arthroplasty TKA.

Methods

68 Patients treated with two-stage exchange arthroplasty were randomized to either a static (32 patients) or an articulating (36 patients) spacer. A power analysis determined that 28 patients per group were necessary to detect a 13º difference in range of motion between groups. Six patients were excluded after randomization, six died, and seven were lost to follow-up prior to two years.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_12 | Pages 73 - 73
1 Oct 2019
Sershon RA Fillingham Y Abdel MP Malkani AL Schwarzkopf R Padgett DE Vail TP Nam D Nahhas CR Culvern C Valle CJD
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Background

The purpose of this multicenter, randomized clinical trial was to determine the optimal dosing regimen of tranexamic acid (TXA) to minimize perioperative blood loss for revision total hip arthroplasty (THA).

Methods

Six centers prospectively randomized 155 revisions to one of four regimens: 1g of intravenous (IV) TXA prior to incision, a double dose regimen of 1g IV TXA prior to incision and 1g IV TXA during wound closure, a combination of 1g IV TXA prior to incision and 1g intraoperative topical TXA, or three doses of 1950mg oral TXA administered 2 hours preoperatively, 6 hours postoperatively, and on the morning of postoperative day one. Randomization was based upon revision subgroups to ensure equivalent group distribution, including: femur only, acetabulum only, both component, explant/spacer, and second stage reimplantation. Patients undergoing an isolated modular exchange were excluded. An a priori power analysis (alpha = 0.05; beta = 0.80) determined 40 patients per group were required to identify a 1g/dL difference in postoperative hemoglobin reduction between groups. Per-protocol analysis involved an analysis of variance, Fisher's exact tests, and two one-sided t-tests for equivalence.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 31 - 31
1 Oct 2019
Heckmann ND Nahhas CR Valle CJD Yi PH Culvern C Gerlinger TL Nam D
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Background

In the setting of a “dry” aspiration, saline lavage is commonly used to obtain a sample for analysis. The purpose of this study is to prospectively determine the impact of saline lavage on synovial fluid markers in revision arthroplasty.

Methods

79 patients undergoing revision hip (19) and knee (60) arthroplasty were enrolled. Intraoperatively, prior to arthrotomy, the maximum amount of fluid possible was aspirated to simulate a dry-tap (“pre-lavage”) followed by subsequent injection with 20 mL of normal saline and re-aspiration (“post-lavage”). Pre and post-lavage synovial white blood cell (WBC) count, percent polymorphonuclear cells (%PMN), and cultures were compared. Statistical analyses utilized the Wilcoxon signed-rank test.


The Bone & Joint Journal
Vol. 101-B, Issue 7_Supple_C | Pages 10 - 16
1 Jul 2019
Fillingham YA Darrith B Calkins TE Abdel MP Malkani AL Schwarzkopf R Padgett DE Culvern C Sershon RA Bini S Della Valle CJ

Aims

Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA. The purpose of this multicentre randomized clinical trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA.

Patients and Methods

From six-centres, 233 revision TKAs were randomized to one of four regimens: 1 g of intravenous (IV) TXA given prior to the skin incision, a double-dose regimen of 1 g IV TXA given both prior to skin incision and at time of wound closure, a combination of 1 g IV TXA given prior to skin incision and 1 g of intraoperative topical TXA, or three doses of 1950 mg oral TXA given two hours preoperatively, six hours postoperatively, and on the morning of postoperative day one. Randomization was performed based on the type of revision procedure to ensure equivalent distribution among groups. Power analysis determined that 40 patients per group were necessary to identify a 1 g/dl difference in the reduction of haemoglobin postoperatively between groups with an alpha of 0.05 and power of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 61 - 61
1 Oct 2018
Hannon CP Calkins TE Li J Culvern C Darrith B Nam D Gerlinger TL Della Valle CJ
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Introduction

Opioids are an important component of multimodal analgesia, but improper utilization places patients at risk for overdose and addiction. The purpose of this randomized controlled trial is to determine whether the quantity of opioid pills prescribed at discharge is associated with the total amount of opioids consumed or unused by patients after total hip (THA) and knee (TKA) arthroplasty.

Methods

304 Opioid naïve patients undergoing THA or TKA were randomized to receive a prescription for either 30 or 90 5mg oxycodone immediate release (OxyIR) tablets at discharge. All patients received acetaminophen, meloxicam, tramadol and gabapentin perioperatively. Daily opioid consumption, reported in morphine equivalent dose (MED), number of unused OxyIR, and pain scores were calculated for 30 days postoperatively with a patient-completed medication diary. The number of OxyIR refills and total MED received were recorded for 90 days postoperatively. Power analysis determined that 141 patients per group were necessary to detect a 25% reduction in means in opiate consumption between groups. Statistical analysis involved t-test, rank sum, and chi-squared tests with alpha=0.05.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_11 | Pages 7 - 7
1 Aug 2018
Calkins T Culvern C Nam D Gerlinger T Levine B Sporer S Della Valle C
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The purpose of this randomized controlled trial is to evaluate the efficacy of using dilute betadine versus sterile saline lavage in aseptic revision total knee (TKA) and hip (THA) arthroplasty to prevent acute postoperative deep periprosthetic joint infection (PJI).

Of the 450 patients that were randomized, 5 did not have 90-day follow-up, 9 did not receive the correct treatment, and 4 were excluded for intraoperative findings consistent with PJI. 221 Patients (144 knees and 77 hips) received saline lavage only and 211 (136 knees and 75 hips) received a three-minute dilute betadine lavage (0.35%) prior to wound closure. Patients were observed for the incidence of acute postoperative deep PJI within 90 days of surgery. Statistical analysis was performed using t-tests or Fisher's exact test where appropriate. Power analysis determined that 285 patients per group are needed to detect a reduction in the rate of PJI from 5% to 1% (alpha=0.05, beta=0.20).

There were seven PJIs in the saline group and one in the betadine lavage group (3.2% vs. 0.5%, p=0.068). There were no significant differences in any baseline demographics between groups suggesting appropriate randomization.

Although we believe the observed difference between treatments is clinically relevant, it was not statistically significant with the sample size enrolled thus far and enrollment is ongoing. Nonetheless, we believe that these data suggests that dilute betadine lavage is a simple method to reduce the rate of acute postoperative PJI in patients undergoing aseptic revision procedures.


The Bone & Joint Journal
Vol. 100-B, Issue 7 | Pages 862 - 866
1 Jul 2018
Darrith B Bell JA Culvern C Della Valle CJ

Aims

Accurate placement of the acetabular component is essential in total hip arthroplasty (THA). The purpose of this study was to determine if the ability to achieve inclination of the acetabular component within the ‘safe-zone’ of 30° to 50° could be improved with the use of an inclinometer.

Patients and Methods

We reviewed 167 primary THAs performed by a single surgeon over a period of 14 months. Procedures were performed at two institutions: an inpatient hospital, where an inclinometer was used (inclinometer group); and an ambulatory centre, where an inclinometer was not used as it could not be adequately sterilized (control group). We excluded 47 patients with a body mass index (BMI) of > 40 kg/m2, age of > 68 years, or a surgical indication other than osteoarthritis whose treatment could not be undertaken in the ambulatory centre. There were thus 120 patients in the study, 68 in the inclinometer group and 52 in the control group. The inclination angles of the acetabular component were measured from de-identified plain radiographs by two blinded investigators who were not involved in the surgery. The effect of the use of the inclinometer on the inclination angle was determined using multivariate regression analysis.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_1 | Pages 45 - 45
1 Jan 2018
Darrith B Bell J Culvern C Della Valle C
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Accurate placement of the acetabular component is essential in Total Hip Arthroplasty (THA). The purpose of this study is to determine if an analog spirit level can improve the surgeon's ability to achieve acetabular inclination within the “safe-zone” of 30 to 50 degrees.

We reviewed 167 primary THAs performed by a single surgeon over 14 months. Procedures were performed at two facilities, an inpatient hospital where a spirit level was utilized and an ambulatory facility where it was not. We excluded 47 patients with a BMI>40, age>68 or a surgical indication other than osteoarthritis who were not candidates for the ambulatory center. Cup inclination angles were measured from de-identified plain radiographs by two blinded investigators not involved in the index procedures. The effect of level usage on inclination angle was determined using multivariate regression analysis.

The mean inclination angle for the 68 hips performed with the level was 42.9 degrees (95% CI: 41.7–44.0) compared to 46.5 degrees (95% CI: 45.2–47.7) for the 52 hips without it (p<.001). Regression analysis demonstrated a 9.1% difference in cup inclination due to the level (p<.001), and THAs performed without the level were 3 times more likely to result in inclinations > 50 degrees (OR 2.8, p=.036). The two investigators' measurements demonstrated a correlation of 0.95 (95% CI: 0.93–0.97).

Use of a simple spirit level resulted in a significant reduction in the number of outliers compared to the freehand technique. The spirit level may be a simple and inexpensive tool to improve acetabular component abduction angles.