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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. 103-B, Issue SUPP_14 | Pages 21 - 21
1 Nov 2021
DeBenedetti A Della Valle CJ Jacobs JJ Nam D
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The purpose of this randomized controlled trial was to evaluate serum metal ion levels in patients undergoing THA with either a standard or modular dual-mobility bearing.

Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or a standard polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Only patients without a prior history of metal implants in their body were eligible for inclusion, thus isolating serum metal ions to the prosthesis itself. Serum metal ion levels were drawn pre-operatively and at 1 year postoperatively. Power analysis determined that 40 patients (20 in each group) were needed to identify a clinically relevant difference in serum cobalt of 0.35 ng/ml (ppb) at 90% power assuming a pooled standard deviation of 0.31 ppb and alpha=0.05; an additional 30% were enrolled to account for potential dropouts.

53 patients were enrolled, with 22 patients in the modular dual-mobility group and 20 in the standard cohort with data available at one-year. No differences in the serum cobalt (0.17 ppb [range 0.07 to 0.50] vs. 0.19 ppb [range 0.07 to 0.62], p = 0.51) or chromium levels (0.19 ppb [range 0.05 to 0.56] vs. 0.16 ppb [range 0.05 to 0.61], p = 0.23) were identified.

At 1 year postoperatively, no differences in serum cobalt or chromium levels were identified with this design of a modular dual mobility bearing when compared to a standard polyethylene bearing.


Bone & Joint Open
Vol. 2, Issue 10 | Pages 858 - 864
18 Oct 2021
Guntin J Plummer D Della Valle C DeBenedetti A Nam D

Aims

Prior studies have identified that malseating of a modular dual mobility liner can occur, with previous reported incidences between 5.8% and 16.4%. The aim of this study was to determine the incidence of malseating in dual mobility implants at our institution, assess for risk factors for liner malseating, and investigate whether liner malseating has any impact on clinical outcomes after surgery.

Methods

We retrospectively reviewed the radiographs of 239 primary and revision total hip arthroplasties with a modular dual mobility liner. Two independent reviewers assessed radiographs for each patient twice for evidence of malseating, with a third observer acting as a tiebreaker. Univariate analysis was conducted to determine risk factors for malseating with Youden’s index used to identify cut-off points. Cohen’s kappa test was used to measure interobserver and intraobserver reliability.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_10 | Pages 32 - 32
1 Oct 2020
Yang J Terhune EB DeBenedetti A Della Valle CJ Gerlinger TL Levine BR Nam D
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Introduction

Wound complications following revision total hip arthroplasty (THA) are associated with an increased risk of superficial and deep infections. Closed incision negative-pressure therapy (ciNPT) has been reported to decrease this risk. This study's purpose was to assess if ciNPT decreases the rate of wound complications following revision THA versus a conventional, silver-impregnated dressing.

Methods

This was a single center, randomized controlled trial of patients undergoing both septic and aseptic revision THA. Patients received either ciNPT or a silver-impregnated dressing (control) for 7 days. Wound complications within 90 days of the procedure were recorded, including: surgical site infection (SSI), periprosthetic joint infection (PJI), prolonged drainage greater than 5 days, erythema requiring antibiotics, and hematoma formation. An a priori power analysis determined 201 patients per cohort were necessary to demonstrate a 10% decrease in wound complication rate.


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.


The Bone & Joint Journal
Vol. 101-B, Issue 6_Supple_B | Pages 31 - 36
1 Jun 2019
Nam D Nunley RM Clohisy JC Lombardi AV Berend KR Barrack RL

Aims

Whether patient-reported pain differs among surgical approaches in total hip arthroplasty (THA) remains unclear. This study’s purposes were to determine differences in pain based on surgical approach (direct anterior (DA) vs posterolateral (PL)) and PL approach incision length.

Patients and Methods

This was a retrospective investigation from two centres and seven surgeons (three DA, three PL, one both) of primary THAs. PL patients were categorized for incision length (6 cm to 8 cm, 8 cm to 12 cm, 12 cm to 15 cm). All patients had cementless femoral and acetabular fixation, at least one year’s follow-up, and well-fixed components. Patients completed a pain-drawing questionnaire identifying the location and intensity of pain on an anatomical diagram. Power analysis indicated 800 patients in each cohort for adequate power to detect a 4% difference in pain (alpha = 0.05, beta = 0.80).


The Bone & Joint Journal
Vol. 101-B, Issue 4 | Pages 365 - 371
1 Apr 2019
Nam D Salih R Nahhas CR Barrack RL Nunley RM

Aims

Modular dual mobility (DM) prostheses in which a cobalt-chromium liner is inserted into a titanium acetabular shell (vs a monoblock acetabular component) have the advantage of allowing supplementary screw fixation, but the potential for corrosion between the liner and acetabulum has raised concerns. While DM prostheses have shown improved stability in patients deemed ‘high-risk’ for dislocation undergoing total hip arthroplasty (THA), their performance in young, active patients has not been reported. This study’s purpose was to assess clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) in young, active patients receiving a modular DM acetabulum and recently introduced titanium, proximally coated, tapered femoral stem design.

Patients and Methods

This was a prospective study of patients between 18 and 65 years of age, with a body mass index (BMI) < 35 kg/m2 and University of California at Los Angeles (UCLA) activity score > 6, who received a modular cobalt-chromium acetabular liner, highly crosslinked polyethylene mobile bearing, and cementless titanium femoral stem for their primary THA. Patients with a history of renal disease and metal hardware elsewhere in the body were excluded. A total of 43 patients (30 male, 13 female; mean age 52.6 years (sd 6.5)) were enrolled. All patients had a minimum of two years’ clinical follow-up. Patient-reported outcome measures, whole blood metal ion levels (ug/l), and periprosthetic femoral BMD were measured at baseline, as well as at one and two years postoperatively. Power analysis indicated 40 patients necessary to demonstrate a five-fold increase in cobalt levels from baseline (alpha = 0.05, beta = 0.80). A mixed model with repeated measures was used for statistical analysis.


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_13 | Pages 11 - 11
1 Oct 2018
Nam D Salih R Riegler V Nunley RM Clohisy JC Lombardi AV Berend KR Barrack RL
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Introduction

Despite well-fixed implants, persistent pain following total hip arthroplasty (THA) remains a concern. Various surgical approaches have been advocated, yet whether patient-reported pain differs amongst techniques has not been investigated. This study's purposes were to determine differences in patient-reported pain based on surgical approach (direct anterior –DA versus posterolateral-PL) or PL approach incision length. Our hypothesis was that no differences in patient-reported pain would be present.

Methods

A retrospective, IRB-approved investigation from 2 centers was performed. 7 fellowship trained arthroplasty surgeons (3 DA, 3 PL, 1 both) enrolled patients undergoing primary THA for non-inflammatory arthritis. PL approach patients were categorized based on incision length (6–8cm, 8–12cm, 12–15cm). Exclusion criteria were a prior hip surgery, revision procedure, or limited postoperative mobility. All THAs were performed using a cementless titanium, proximally coated, tapered femoral stem and hemispherical acetabular component. All patients had a minimum of 1-year clinical follow-up with radiographically well-fixed components.

A pain-drawing questionnaire was administered in which patients identify the location and intensity of pain on an anatomic diagram. Independent Student's t-tests and Chi-square analyses were performed (p<0.05 = significant). Power analysis indicated 800 patients in each cohort would provide adequate power to detect a 4% difference in patient-reported pain (alpha = 0.05, beta = 0.80).


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.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_11 | Pages 3 - 3
1 Aug 2018
Barrack R Nam D Salih R Nahhas C Nunley R
Full Access

To assess clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) in young, active patients receiving a modular dual mobility acetabulum and recently introduced titanium, proximally coated, tapered femoral stem design.

This was a prospective study of patients  65 years of age, with a BMI  35 kg/m2, and UCLA activity score > 6 who received a modular cobalt chrome acetabular liner, highly cross-linked polyethylene mobile bearing, and cementless titanium femoral stem for their primary THA. Patients with a history of renal disease and metal hardware elsewhere in the body were excluded. All patients had a minimum of 2-year clinical follow-up.

Patient reported outcome measures, whole blood metal ion levels (ug/L), and periprosthetic femur BMD were measured at baseline and at 1- and 2-years postoperatively.

43 patients (30 male, 13 female; mean age 52.6 ± 6.5 years) were enrolled. Harris Hip Scores improved from 54.1 ± 20.5 to 91.2 ± 10.8 at 2 years postoperatively (p<0.001). All patients had radiographically well-fixed components, no patients have sustained an instability event, and no patients have required a return to the operating room or revision procedure.

Mean cobalt levels increased from 0.065 ± 0.03 ug/L preoperatively to 0.30 ± 0.51 at 1-year postoperatively (p=0.01), but decreased at 2 years postoperatively to 0.16 ± 0.23 (p=0.2) (Table 1). Four patients (9.3%) had a cobalt level outside the reference range (0.03 to 0.29ug/L) at 2 years postoperatively with values from 0.32 to 0.94. None were symptomatic

The mean femoral BMD ratio was maintained in Gruen zones 2 thru 7 at both 1- and 2-years postoperatively using this stem design (Table 2). At 2 years postoperatively, BMD in the medial calcar was 101.5% of the baseline value.

Use of a modular dual mobility prosthesis and cementless, tapered femoral stem has shown encouraging results in young, active patients undergoing primary THA. Elevation in mean cobalt levels and the presence of four patients outside the reference range at 2 years postoperatively demonstrates the necessity of continued surveillance in this cohort.

For any figures or tables, please contact authors directly: barrackr@wustl.edu


The Bone & Joint Journal
Vol. 99-B, Issue 1_Supple_A | Pages 31 - 36
1 Jan 2017
Haynes J Nam D Barrack RL

Aims

The purpose of our study is to summarise the current scientific findings regarding the impact of obesity on total hip arthroplasty (THA); specifically the influence of obesity on the timing of THA, incidence of complications, and effect on clinical and functional outcomes.

Materials and Methods

We performed a systematic review that was compliant with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify prospective studies from the PubMed/Medline, Embase, and Cochrane Library databases that evaluated primary THA in obese (body mass index (BMI) ≥ 30 kg/m2) patients.


The Bone & Joint Journal
Vol. 98-B, Issue 2 | Pages 173 - 178
1 Feb 2016
Sassoon A Nam D Jackups R Johnson SR Nunley RM Barrack RL

Aims

This study investigated whether the use of tranexamic acid (TXA) decreased blood loss and transfusion related cost following surface replacement arthroplasty (SRA).

Methods

A retrospective review of patients treated with TXA during a SRA, who did not receive autologous blood (TXA group) was performed. Two comparison groups were established; the first group comprised of patients who donated their own blood pre-operatively (auto group) and the second of patients who did not donate blood pre-operatively (control). Outcomes included transfusions, post-operative haemoglobin (Hgb), complications, and length of post-operative stay.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 7 | Pages 994 - 997
1 Jul 2012
Cross MB Nam D van der Meulen MCH Bostrom MPG

An 81-year-old woman presented with a fracture in the left femur. She had well-fixed bilateral hip replacements and had received long-term bisphosphonate treatment. Prolonged bisphosphonate use has been recently linked with atypical subtrochanteric and diaphyseal femoral fractures. While the current definition of an atypical fracture of the femur excludes peri-prosthetic fractures, this case suggests that they do occur and should be considered in patients with severe osteopenia. Union of the fracture followed cessation of bisphosphonates and treatment with teriparatide. Thus, this case calls into question whether prophylactic intramedullary nailing is sufficient alone to treat early or completed atypical femoral fractures.