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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).


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 935 - 941
1 Sep 2024
Ailaney N Guirguis PG Ginnetti JG Balkissoon R Myers TG Ramirez G Thirukumaran CP Ricciardi BF

Aims

The purpose of this study was to determine the association between prior sleeve gastrectomy in patients undergoing primary total hip and knee arthroplasty, and 90-day complications, incidence of revision arthroplasty, and patient-reported outcome scores at final follow-up.

Methods

This is a retrospective, single-centre analysis. Patients undergoing primary hip or knee arthroplasty with a prior sleeve gastrectomy were eligible for inclusion (n = 80 patients). A morbidly obese control group was established from the same institutional registry using a 1:2 match, for cases:controls with arthroplasty based on propensity score using age, sex, pre-sleeve gastrectomy BMI, Current Procedural Terminology code to identify anatomical location, and presurgical haemoglobin A1C. Outcomes included 90-day complications, incidence of revision arthroplasty, and patient-reported outcome scores at final follow-up. Multivariable logistic regressions evaluated associations of underlying preoperative demographic and treatment characteristics with outcomes.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 4 - 4
17 Jun 2024
Carter T Oliver W Bell K Graham C Duckworth A White T Heinz N
Full Access

Introduction

Unstable ankle fractures are routinely managed operatively. Due to soft-tissue and implant related complications, there has been recent literature reporting on the non-operative management of well-reduced medial malleolus fractures following fibular stabilisation, but with limited evidence supporting routine application. This trial assessed the superiority of internal fixation of well-reduced (displacement ≤2mm) medial malleolus fractures compared with non-fixation following fibular stabilisation.

Methods and participants

Superiority, pragmatic, parallel, prospective randomised clinical trial conducted over a four year period. A total of 154 adult patients with a bi- or trimalleolar fractures were recruited from a single centre. Open injuries and vertical medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at one-year post-randomisation. Complications and radiographic outcomes were documented over the follow-up period.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_2 | Pages 10 - 10
2 Jan 2024
Martínez T Mariscal G Hevia E Barrios C
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The multimodal management of canal stenosis is increasing, and inhibitors of central sensitization are playing a crucial role in central sensitization processes. Pregabalin and gabapentin are antiepileptic drugs that reduce presynaptic excitability. The objective of this study was to investigate whether the use of pregabalin and gabapentin is effective in the symptomatic management of canal stenosis. A literature search was conducted in four databases. The inclusion criteria were studies that compared pregabalin or gabapentin with a control group in lumbar canal stenosis. Randomized clinical trials and a comparative retrospective cohort study were included. The main clinical endpoints were VAS/NRS, ODI, and RDQ (Roland Morris Disability Questionnaire) at 2, 4, 8 weeks, and 3 months, adverse events, and walking distance were also collected. Data were combined using Review Manager 5.4 software. Six studies and 392 patients were included. The mean age was 60.25. No significant differences were observed in VAS at 2, 4, and 8 weeks: (MD: 0.23; 95% CI: −0.63-1.09), (MD: −0.04; 95% CI: −0.64 to −0.57), and (MD: −0.6; 95% CI: −1.22 to 0.02). Significant differences were observed in favor of pregabalin with respect to VAS at three months: (MD: −2.97; 95% CI: −3.43 to −2.51). No significant differences were observed in ODI (MD: −3.47; 95% CI: −7.15 to −0.21). Adverse events were significantly higher in the pregabalin/gabapentin group (OR 5.88, 95%CI 1.28-27.05). Walking distance and RDQ could not be compared, although the results were controversial. Gabapentinoids have not been shown to be superior to other drugs used in the treatment of LSS or to placebo. However, they have shown a higher incidence of adverse effects, improved results in VAS at 3 months, and a slight improvement in ambulation at 4 months in combination with NSAIDs compared to NSAIDs in monotherapy


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 4 - 4
11 Apr 2023
Lynch J Perriman D Scarvell J Pickering M Galvin C Smith P
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Total knee replacement (TKR) design aims to restore normal kinematics with emphasis on flexion range. The survivorship of a TKR is dependent on the kinematics in six-degrees-of-freedom (6-DoF). Stepping up, such as stair ascent is a kinematically demanding activity after TKR. The debate about design choice has not yet been informed by 6-DoF in vivo kinematics. This prospective randomised controlled trial (RCT) compared kneeling kinematics in three TKR designs.

68 participants were randomised to receive either cruciate retaining (CR-FB), rotating platform (CR-RP) or posterior stabilised (PS-FB) prostheses. Image quality was sufficient for 49 of these patients to be included in the final analysis following a minimum 1-year follow-up. Patients completed a step-up task while being imaged using single-plane fluoroscopy. Femoral and tibial computer-aided design (CAD) models for each of the TKR designs were registered to the fluoroscopic images using bespoke software OrthoVis to generate six-degree-of-freedom kinematics. Differences in kinematics between designs were compared as a function of flexion.

There were no differences in terminal extension between the groups. The CR-FB was further posterior and the CR-RP was more externally rotated at terminal extension compared to the other designs. Furthermore, the CR-FB designs was more posteriorly positioned at each flexion angle compared to both other designs. Additionally, the CR-RP design had more external femoral rotation throughout flexion when compared with both fixed bearing designs. However, there were no differences in total rotation for either step-up or down. Visually, it appears there was substantial variability between participants in each group, indicating unique patient-specific movement patterns.

While use of a specific implant design does influence some kinematic parameters, the overall patterns are similar. Furthermore, there is high variability indicating patient-specific kinematic patterns. At a group level, none of these designs appear to provide markedly different step-up kinematic patterns. This is important for patient expectations following surgery. Future work should aim to better understand the unique patient variability.


Bone & Joint Open
Vol. 4, Issue 3 | Pages 205 - 209
16 Mar 2023
Jump CM Mati W Maley A Taylor R Gratrix K Blundell C Lane S Solanki N Khan M Choudhry M Shetty V Malik RA Charalambous CP

Aims

Frozen shoulder is a common, painful condition that results in impairment of function. Corticosteroid injections are commonly used for frozen shoulder and can be given as glenohumeral joint (GHJ) injection or suprascapular nerve block (SSNB). Both injection types have been shown to significantly improve shoulder pain and range of motion. It is not currently known which is superior in terms of relieving patients’ symptoms. This is the protocol for a randomized clinical trial to investigate the clinical effectiveness of corticosteroid injection given as either a GHJ injection or SSNB.

Methods

The Therapeutic Injections For Frozen Shoulder (TIFFS) study is a single centre, parallel, two-arm, randomized clinical trial. Participants will be allocated on a 1:1 basis to either a GHJ corticosteroid injection or SSNB. Participants in both trial arms will then receive physiotherapy as normal for frozen shoulder. The primary analysis will compare the Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include OSS at six and 12 months, range of shoulder movement at three months, and Numeric Pain Rating Scale, abbreviated Disabilities of Arm, Shoulder and Hand score, and EuroQol five-level five-dimension health index at three months, six months, and one year after injection. A minimum of 40 patients will be recruited to obtain 80% power to detect a minimally important difference of ten points on the OSS between the groups at three months after injection. The study is registered under ClinicalTrials.gov with the identifier NCT04965376.


Aims. Our objective was to conduct a systematic review and meta-analysis, to establish whether differences arise in clinical outcomes between autologous and synthetic bone grafts in the operative management of tibial plateau fractures. Methods. A structured search of MEDLINE, EMBASE, the online archives of Bone & Joint Publishing, and CENTRAL databases from inception until 28 July 2021 was performed. Randomized, controlled, clinical trials that compared autologous and synthetic bone grafts in tibial plateau fractures were included. Preclinical studies, clinical studies in paediatric patients, pathological fractures, fracture nonunion, or chondral defects were excluded. Outcome data were assessed using the Risk of Bias 2 (ROB2) framework and synthesized in random-effect meta-analysis. The Preferred Reported Items for Systematic Review and Meta-Analyses guidance was followed throughout. Results. Six studies involving 353 fractures were identified from 3,078 records. Following ROB2 assessment, five studies (representing 338 fractures) were appropriate for meta-analysis. Primary outcomes showed non-significant reductions in articular depression at immediate postoperative (mean difference -0.45 mm, p = 0.25, 95%confidence interval (CI) -1.21 to 0.31, I. 2. = 0%) and long-term (> six months, standard mean difference -0.56, p = 0.09, 95% CI -1.20 to 0.08, I. 2. = 73%) follow-up in synthetic bone grafts. Secondary outcomes included mechanical alignment, limb functionality, and defect site pain at long-term follow-up, perioperative blood loss, duration of surgery, occurrence of surgical site infections, and secondary surgery. Mean blood loss was lower (90.08 ml, p < 0.001, 95% CI 41.49 to 138.67) and surgery was shorter (16.17 minutes, p = 0.04, 95% CI 0.39 to 31.94) in synthetic treatment groups. All other secondary measures were statistically comparable. Conclusion. All studies reported similar methodologies and patient populations; however, imprecision may have arisen through performance variation. These findings supersede previous literature and indicate that, despite perceived biological advantages, autologous bone grafting does not demonstrate superiority to synthetic grafts. When selecting a void filler, surgeons should consider patient comorbidity, environmental and societal factors in provision, and perioperative and postoperative care provision. Cite this article: Bone Jt Open 2022;3(3):218–228


Bone & Joint Open
Vol. 2, Issue 9 | Pages 773 - 784
1 Sep 2021
Rex SS Kottam L McDaid C Brealey S Dias J Hewitt CE Keding A Lamb SE Wright K Rangan A

Aims

This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI.

Methods

MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_5 | Pages 2 - 2
1 Mar 2021
Higuera-Rueda C Emara A Nieves-Malloure Y Klika AK Cooper H Cross M Guild G Nam D Nett M Scuderi G Cushner F Silverman R
Full Access

Aim

This was a multicenter, randomized, clinical trial to compare the 90-day 1) incidence of surgical site complications (SSC); 2) health care utilization (the number of dressing changes, readmission, and reoperation); and 3) the patient-reported outcomes (PRO) in high-risk patients undergoing revision total knee arthroplasty (rTKA) with postoperative closed incision negative pressure wound therapy (ciNPT) versus a standard of care (SOC) silver-impregnated occlusive dressing.

Method

A total of 294 rTKA patients (15 centers) at high-risk for wound complications were prospectively randomized to receive either SOC or ciNPT (n = 147 each). The ciNPT system was adjusted at 125 mmHg of suction. Investigated outcomes were assessed weekly up to 90 days after surgery. A preset interim analysis was conducted at 50% of the intended sample size, with planned discontinuation for clear efficacy/harm if a significance of p < 0.005 was attained.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 18 - 18
1 Mar 2021
Perey B Chung K Kim H Malay S Shauver M
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To compare 24-month patient-reported outcomes after surgical treatment or casting in patients age 60 years of age or older with unstable distal radius fractures (DRF's).

The Wrist and Radius Injury Surgical Trial (WRIST), is the largest randomized, multicenter trial in Hand Surgery, which enrolled 304 adults with isolated, unstable DRF's at 24 institutions. WRIST participants were followed for 24 months- longest follow-up among prospective studies comparing four treatment methods. Patients who agreed to surgical treatment (n=187) were randomized to internal fixation with volar plate (VLPS), external fixation, or percutaneous pinning; patients who preferred conservative management (n=117) received casting. The primary outcome was 24-month Michigan Hand Outcomes Questionnaire (MHQ) Summary score. Secondary outcomes were MHQ Domain scores.

At 24-month assessment, participants' mean MHQ Summary score was 86 (95% CI: 83,88), representing good hand function. Participants reported good return of their Activities of Daily Living (ADLs) with a mean MHQ ADL score of 88 (95% CI: 85,91). Finally, participants were satisfied, with a mean MHQ Satisfaction score of 84 (95% CI: 80,88). There were no significant differences in score by treatment group in any MHQ domain at 24 months. Six weeks after surgery, VLPS participants scored significantly higher than the other three groups on (ADLs) and Satisfaction (both p<0.0001), whereas participants who received external fixation scored significantly lower than the casting and VLPS groups on the same domains. By the 3-month assessment, the gap between VLPS and casting had disappeared but external fixation participants continued to report significantly worse scores. External fixation participants did not report comparable ADL scores to the other three groups until 12 months after surgery.

Participants reported good outcomes 24 months after DRF regardless of treatment. Casting and VLPS are both acceptable treatments for older adults. The decision between the two treatments should be made considering patient goals regarding recovery speed and desire to avoid surgical risks. External fixation should be avoided because of worse outcomes in the year after surgery and the risk of pin site infections.


Bone & Joint Open
Vol. 2, Issue 2 | Pages 72 - 78
1 Feb 2021
Agni NR Costa ML Achten J O’Connor H Png ME Peckham N Dutton SJ Wallis S Milca S Reed M

Aims

Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture.

Methods

The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group.


Bone & Joint 360
Vol. 9, Issue 6 | Pages 41 - 43
1 Dec 2020


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
Full Access

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.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_7 | Pages 33 - 33
1 Jul 2020
McRae S Matthewson G Leiter J MacDonald PB Lenschow S
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The purpose of this study was to quantify tibial tunnel enlargement at 3-, 6- and 12-months post-anterior cruciate ligament reconstruction (ACLR), and evaluate the magnitude of tunnel widening with use of a Poly (L-lactic Acid) interference screw (PLLA (Bioscrew XtraLok, Conmed, New York)) compared to a Poly (L-lactic Acid) + tricalcium phosphate interference screw (PLLA+TCP (GENESYS Matryx screw comprised of microTCP and 96L/4D PLA, Conmed, New York)).

This was a prospective randomized controlled trial with two parallel groups. Eighty unilateral ACL-deficient participants awaiting ACLR surgery were recruited between 2013 and 2017 from the clinic of a sole fellowship trained orthopaedic surgeon. Patients had to be skeletally mature and less than 45 years old, with no concomitant knee ligament injuries requiring surgery, chondromalacia, or previous history of ipsilateral knee joint pathology, surgery or trauma to the knee.

Participants were randomized intra-operatively into either the PLLA or PLLA+TCP tibial interference screw fixation group. Study time points were pre-, 3-, 6-, and 12-months post ACLR. Participants underwent x-rays with a 25 mm calibration ball, IKDC knee assessment, and completed the ACL-Quality of Life score (ACL-QOL) at each visit.

Measurement (mm) of the most proximal and distal extents as well as the widest point of the tibial tunnel were taken using efilm (IBM Watson Health) and were standardized relative to the calibration ball. A contrast inverter was used to determine clear borders based on contrast between normal and drilled bone. In addition, a subjective evaluation of the tunnel was conducted looking for bowing of the borders of the tunnel or change in tunnel shape, categorizing the tunnel as widened or not widened.

Differences between groups at each time point were evaluated using independent t-tests corrected for multiple comparisons. Tunnel width was also compared as a percentage of actual screw size at 12-months post-operative. Categorical data were compared using Fisher's Exact Test. Forty participants were randomized to each group with mean age (SD) of 29.7 (7.6) and 29.8 (9.1), for PLLA and PLLA+TCP, respectively. There were no differences between groups in age, gender or ACL-QOL.

There were no differences found between groups at any time point in either tunnel width measurements or tunnel width as a percentage of actual screw size. The greatest difference between groups was noted in the measurement of the widest point on lateral x-ray view with a mean difference of 11%. Based on subjective evaluation of tunnel shape, three participants had visible widening in the PLLA group, and two in the PLLA+TCP group (p=NS).

No differences in tunnel widening were identified between ACL reconstruction patients using a PLLA interference screw compared to a PLLA+TCP screw for tibial fixation up to 12-months post-operative.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 22 - 22
1 Feb 2020
Van De Kleut M Athwal G Yuan X Teeter M
Full Access

Introduction

Reverse total shoulder arthroplasty (RTSA) is rapidly being adopted as the standard procedure for a growing number of shoulder arthropathies. Though short-term outcomes are promising, mid- and long-term follow-ups present a number of complications – among them, humeral stem and glenosphere component loosening. Though not the primary complication, previously reported aseptic loosening required revision in 100% of cases. As the number of patients undergoing RTSA increases, especially in the younger population, it is important for surgeons to identify and utilize prostheses with stable long-term fixation. It has previously been shown in the hip and knee literature that implant migration in the first two years following surgery is predictive of later failure due to loosening in the 5=10-year postoperative window. The purpose of this study is to, for the first time, evaluate the pattern and total magnitude of implant migration in reverse shoulder arthroplasty using the gold standard imaging technique radiostereometric analysis (RSA).

Methods

Forty patients were prospectively randomized to receive either a cemented or press-fit humeral stem, and a glenosphere secured to the glenoid with either autologous bone graft or 3D printed porous titanium for primary reverse total shoulder arthroplasty. Following surgery, participants are imaged using RSA, a calibrated, stereo x-ray technique. Radiographs are acquired at 6 weeks (baseline), 3 months, 6 months, 1 year, and 2 years. Migration of the humeral stem and glenosphere at each time point is compared to baseline. Migration of the prostheses is independently compared between humeral stem fixation groups and glenosphere fixation groups using a two-way repeated measures ANOVA with Tukey's test for multiple comparisons.


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.


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1192 - 1198
1 Oct 2019
Sköldenberg OG Rysinska AD Chammout G Salemyr M Mukka SS Bodén H Eisler T

Aims

Radiostereometric analysis (RSA) studies of vitamin E-doped, highly crosslinked polyethylene (VEPE) liners show low head penetration rates in cementless acetabular components. There is, however, currently no data on cemented VEPE acetabular components in total hip arthroplasty (THA). The aim of this study was to evaluate the safety of a new cemented VEPE component, compared with a conventional polyethylene (PE) component regarding migration, head penetration, and clinical results.

Patients and Methods

We enrolled 42 patients (21 male, 21 female) with osteoarthritis and a mean age of 67 years (sd 5), in a double-blinded, noninferiority, randomized controlled trial. The subjects were randomized in a 1:1 ratio to receive a reverse hybrid THA with a cemented component of either argon-gas gamma-sterilized PE component (controls) or VEPE, with identical geometry. The primary endpoint was proximal implant migration of the component at two years postoperatively measured with RSA. Secondary endpoints included total migration of the component, penetration of the femoral head into the component, and patient-reported outcome measurements.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 14 - 14
1 Apr 2019
Van De Kleut M Athwal G Yuan X Teeter M
Full Access

Introduction

Total shoulder arthroplasty is the fastest growing joint replacement in recent years, with projected compound annual growth rates of 10% for 2016 through 2021 – higher than those of both the hip and knee combined. Reverse total shoulder arthroplasty (RTSA) has gained particular interest as a solution for patients with irreparable massive rotator cuff tears and failed conventional shoulder replacement, for whom no satisfactory intervention previously existed. As the number of indications for RTSA continues to grow, so do implant designs, configurations, and fixation techniques. It has previously been shown that continuous implant migration within the first two years postoperatively is predictive of later loosening and failure in the hip and knee, with aseptic loosening of implant components a guaranteed cause for revision in the reverse shoulder. By identifying implants with a tendency to migrate, they can be eliminated from clinical practice prior to widespread use. The purpose of this study is to, for the first time, evaluate the pattern and magnitude of implant component migration in RTSA using the gold standard imaging technique radiostereometric analysis (RSA).

Methods

Forty patients were prospectively randomized to receive either a cemented or press-fit humeral stem, and a glenosphere secured to the glenoid with either autologous bone graft or 3D printed porous titanium (Aequalis Ascend Flex, Wright Medical Group, Memphis, TN, USA) for primary reverse total shoulder arthroplasty. Following surgery, partients are imaged using RSA, a calibrated, stereo x-ray technique, at 6 weeks (baseline), 3 months, 6 months, 1 year, and 2 years.

Migration of the humeral stem and glenosphere at each time point is compared to baseline. Preliminary results are presented, with 15 patients having reached the 6-month time point by presentation.


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