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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. 100-B, Issue SUPP_12 | Pages 48 - 48
1 Oct 2018
Fillingham YA Darrith B Calkins T Abdel MP Malkani AL Schwarzkopf R Padgett DE Sershon RA Bini S Della Valle CJ
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Introduction

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 that is associated with greater blood loss. The purpose of this multi-center randomized trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA.

Methods

233 Septic and aseptic revision TKA from six-centers were randomized to either receive 1g pre-incision intravenous (IV) TXA, 1g pre- and post-incision IV TXA, 1g pre-incision IV and 1g intra-operative topical TXA, or three doses of 1950mg oral TXA given 2 hours pre-operatively, 6 hours post-operatively, and the morning of postoperative day 1. Randomization was performed based on type of revision to ensure equivalent distribution among groups. The primary outcome was reduction in hemoglobin. Power analysis determined 40 patients per group were necessary to identify a 1g/dL difference with an alpha of 0.05 and beta of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 31 - 31
1 Oct 2020
Jayakumar P Furlough K Uhler L Grogan-Moore M Gliklich R Rathouz P Bozic KJ
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Introduction

The application of artificial intelligence (A.I) using patient reported outcomes (PROs) to predict benefits, risks, benefits and likelihood of improvement following surgery presents a new frontier in shared decision-making. The purpose of this study was to assess the impact of an A.I-enabled decision aid versus patient education alone on decision quality in patients with knee OA considering total knee replacement (TKR). Secondarily we assess impact on shared decision-making, patient satisfaction, functional outcomes, consultation time, TKR rates and treatment concordance.

Methods

We performed a randomized controlled trial involving 130 new adult patients with OA-related knee pain. Patients were randomized to receive the decision aid (intervention group, n=65) or educational material only (control group, n=65) along with usual care. Both cohorts completed patient surveys including PROs at baseline and between 6–12 weeks following initial evaluation or TKR. Statistical analysis included linear mixed effect models, Mann-Whitney U tests to assess for differences between groups and Fisher's exact test to evaluate variations in surgical rates and treatment concordance.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 907 - 915
1 Sep 2024
Ross M Zhou Y English M Sharplin P Hirner M

Aims

Knee osteoarthritis (OA) is characterized by a chronic inflammatory process involving multiple cytokine pathways, leading to articular cartilage degeneration. Intra-articular therapies using pharmaceutical or autologous anti-inflammatory factors offer potential non-surgical treatment options. Autologous protein solution (APS) is one such product that uses the patient’s blood to produce a concentrate of cells and anti-inflammatory cytokines. This study evaluated the effect of a specific APS intra-articular injection (nSTRIDE) on patient-reported outcome measures compared to saline in moderate knee OA.

Methods

A parallel, double-blinded, placebo-controlled randomized controlled trial was conducted, where patients with unilateral moderate knee OA (Kellgren-Lawrence grade 2 or 3) received either nSTRIDE or saline (placebo) injection to their symptomatic knee. The primary outcome was the difference in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months post-intervention. Secondary outcomes included WOMAC component scores, Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analogue scale (VAS) scores at all follow-up timepoints (three, six, and 12 months).


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 45 - 45
1 Oct 2018
Mihalko WM Richey PA Johnson KC Singhal K Neiberg RH Bahnson JL
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Introduction. Overwhelming evidence has established obesity as a risk factor for osteoarthritis (OA) of the knee. Randomized clinical trials such as the Look AHEAD study have shown long term successful intentional weight loss with an intensive lifestyle intervention (ILI) in overweight and obese type 2 diabetics. Weight loss can also decrease knee pain in persons who have OA, but it is unknown if intentional weight loss can reduce the risk of TKR. To answer this question, data from the Look AHEAD study were examined to determine if intentional weight loss could reduce the risk of TKR. Methods. Look AHEAD is a multicenter, randomized trial which began in August 2001 and follow-up continued for a median of 11.3 years at 16 academic centers. 5145 persons aged 45–76 with diabetes were randomized to either an ILI with reduced calorie consumption and increased physical activity designed or to diabetes support and education intervention (DSE). TKR events were ascertained every 6 months. Retrospective data of reported knee pain was assessed using the WOMAC knee pain questionnaire. Participants with partial TKR or revisions were excluded. Cox proportional hazard models were used to relate baseline BMI category (obese, Class I, Class II, or Class III obesity), baseline knee pain, and treatment group with TKR. Weight change category (lost<=5%, stable, gained>=2%) from baseline to year 1 follow-up by treatment assignment was also examined as a predictor of TKR after excluding TKR occurring prior to year 1. Results. Out of the randomized participants, 2171 reported knee pain (43%) at the baseline visit (p=0.81). WOMAC knee pain score did not differ by random assignment (ILI:3.6±2.9, DSE:3.9±3.0, p=0.08). During follow up there were 631 TKRs reported by participants. TKR was more common in heavier (p<0.001), and older (p<0.001) participants and did not differ by randomization. Heterogeneity of treatment effect was observed with baseline knee pain (interaction p = 0.02), therefore analyses were stratified by presence or absence of knee pain at baseline. In persons without knee pain at baseline, there was a 29% reduced rate of TKR in the ILI group compared to the DSE group (HR[95%CI] 0.71[0.52,0.96]; Figure 1A). Whereas in persons with knee pain at baseline, there was a trend for the ILI to have an increased rate of TKR compared to DSE (1.11[0.92, 1.33]; Figure 1B). In both sets of analyses, obese participants had significantly higher hazard of TKR than overweight participants (No pain: Class I 1.78[1.04,3.05], Class II 2.27 [1.31,3.94], Class III 2.94[1.67,5.18]; With pain: Class I 1.70[1.12,2.59], Class II 2.42 [1.60,3.65], Class III 2.80[1.85,4.23]). When TKR incidence was examined by weight change at year 1 there was no difference in weight change category between randomization groups in persons with knee pain (interaction p=0.20) or without baseline knee pain (interaction p=0.87) (Figure 1C and D) or for the overall effect of year 1 weight loss category in either stratum (with knee pain p=0.26, without knee pain p=0.48). However, in persons without knee pain at baseline, ILI had a marginal reduction in hazard of TKR compared to DSE (0.71[0.49, 1.05]) but not in the group with baseline knee pain. Conclusions. In persons with no knee pain at baseline and who were overweight or had Class I or II obesity, ILI seemed to reduce the risk of TKR compared to DSE. In contrast, persons with knee pain who gained weight at 1 year and were randomized to ILI had the highest risk of TKR. This suggests that weight loss to prevent TKR may be more effective prior to the development of significant knee pain. After the onset of knee pain however, low impact or non-weight bearing activity should be considered to avoid worsening knee symptoms. For any figures or tables, please contact authors directly