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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 13 - 13
19 Aug 2024
DeBenedetti A Weintraub MT Valle CJD Jacobs JJ Nam D
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The purpose of this randomized controlled trial was to evaluate serum metal levels in patients undergoing total hip arthroplasty (THA) with a conventional compared to a modular dual-mobility bearing.

Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or conventional polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Serum metal levels were drawn pre-operatively then annually for a minimum of two years postoperatively. An a priori power analysis determined that 40 patients (20 per cohort) were needed to identify a clinically relevant difference in serum cobalt of 0.35 ng/ml (ppb) at 90% power.

Forty-six patients were randomized to a modular dual-mobility (n=25) or conventional bearing (n=21) with 40 at a minimum follow-up of two years. No differences in serum cobalt (mean 0.14 ppb [range, 0.075–0.29] vs. 0.20 ppb [range, 0.075–0.57], p=0.39) or chromium levels (mean 0.14 ppb [range, 0.05–0.50] vs. 0.12 ppb [range, 0.05–0.35], p=0.65) were identified between the modular dual-mobility and conventional cohorts, respectively.

There was no statistically significant difference in serum Co or Cr at two years postoperatively in subjects implanted with a ceramic head and this particular dual mobility bearing in comparison to a ceramic head and a conventional acetabular component. While modest expected elevations in serum Co and Cr were observed in the dual mobility group, in no case did the Co level exceed the laboratory reference range nor the threshold of one part per billion that has been associated with adverse local tissue reactions to mechanically-assisted crevice corrosion.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 88 - 88
19 Aug 2024
Kendall J Forlenza EM DeBenedetti A Levine BR Valle CJD Sporer S
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An intra-articular steroid injection can be a useful diagnostic tool in patients presenting with debilitating hip pain and radiographically mild osteoarthritis. The clinical and patient reported outcomes associated with patients who have radiographically mild osteoarthritis and undergo total hip arthroplasty (THA) remain poorly studied.

Patients undergoing primary, elective THA at a single academic medical center by a fellowship-trained adult reconstruction surgeon between 2017–2023 were identified. Only those patients who underwent an intra-articular corticosteroid injection into the operative hip within one year of surgery were included. Patients were divided into two cohorts based on the severity of their osteoarthritis as determined by preoperative radiographs; those with Kellgren-Lawrence (KL) grade I-II arthritis were classified as “mild” whereas those with KL grade III-IV arthritis were classified as “severe”. Clinical and patient reported outcomes at final follow-up were compared between cohorts.

The final cohorts included 25 and 224 patients with radiographically mild and severe osteoarthritis, respectively. There were no baseline differences in age, gender or time between intra-articular corticosteroid injection and THA between cohorts. There were no significant differences in the preoperative or postoperative HOOS JR values between patients with mild or severe arthritis (all p>0.05). There were no significant differences in the change in HOOS JR scores from the preoperative to final follow-up timepoints between cohorts. There were no significant differences in the percentage of patients who achieved the minimal clinically important difference (MCID) on the HOOS JR questionnaire between cohorts.

Patients with radiographically mild osteoarthritis who feel relief of their hip pain following an intra-articular corticosteroid injection report similar preoperative debility and demonstrate similar improvements in patient reported outcome scores following THA compared to patients with radiographically severe osteoarthritis.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 11 - 11
19 Aug 2024
Hamilton JL Gianotti S Impergre A AbuAlia M Markovics A Jacobs JJ Valle CJD Wimmer MA
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We created TiO2 nanotubes (TNTs) on the surface of titanium (Ti) implants with subsequential loading with gentamicin and chitosan, acting as a control release agent, by electrophoretic deposition (EPD). We hypothesized femoral implants with TNTs loaded with gentamicin and chitosan would localize antibiotic to the implant and surgical site and prevent PJI in a mouse model.

Ti-6Al-4V ELI wires underwent TNT surface modification by two-step anodization. EPD was then used to load gentamicin and chitosan onto the Ti wire with surface TNTs. Control Ti wires contained TNTs with EPD of chitosan only. 12-week-old male C57BL/6J mice underwent received a right femoral intramedullary implant followed by inoculation at the surgical site with 1×103 CFUs of bioluminescent Xen36 Staphylococcus aureus (S. aureus). Mice were randomly divided into two implant groups: 1) Gentamicin + Chitosan Group (n=7; experimental group); 2) Chitosan Group (n=7; control group). Outcomes included: 1) Relative S. aureus abundance by bioluminescence imaging; 2) Quantification of S. aureus at the implant and surrounding tissue by colony forming unit (CFU) analysis; 3) Scanning electron microscopy (SEM) for implant bacterial biofilm; 4) Radiographic signs of PJI.

Over 14 days assessment following wire implantation and inoculation with S. aureus, the experimental group had no evidence of infection based on i) no increased Xen36 S. aureus bioluminescence signal and ii) no CFUs present. All control had increased bioluminescence signal, above baseline, at all time-points and presence of CFUs.

Ti femoral implants modified with surface TNTs and coated with gentamicin and chitosan through EPD prevented PJI in all mice through 14 days. In comparison, all control mice demonstrated evidence of PJI over 14 days. Implants with TNTs and EPD of gentamicin were highly effective in this mouse PJI model.


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.