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Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 67 - 67
1 Jul 2020
Michalek A Nguyen D Varden L
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As the intervertebral disc is largely avascular, needle injection is the most practical method for delivery of therapeutic agents used in treatments for degenerative disc disease. Intradiscal pressure increases during injection, and insufficient recovery time prior to needle retraction may result in injectate leakage. In order to determine the maximum pressure and post-injection recovery time for a given injection volume and rate, an analytical model of intradiscal injection was developed and calibrated experimentally.

A governing equation was derived defining intradiscal pressure as a function of effective permeability, initial elastic stiffness, nonlinear stiffness term, and injection rate. The equation was solved using a fourth order Runge-Kutta routine with a 0.05s time step and a ramp-dwell injection.

The model was calibrated by performing controlled intradiscal injections on five bovine caudal intervertebral discs. Three had adjacent vertebrae intact, while two were separated from vertebrae and constrained between porous stainless steel platens. A syringe driven by a linear actuator was used to inject phosphate buffered saline through a 21g hypodermic needle inserted radially into the disc to a depth of one half of the disc diameter. Injection was performed at a rate of 75μL/s to a volume of 250μL followed by a 240s dwell. Fluid pressure was recorded during both the injection phase and subsequent recovery phase. For each experimental pressure vs time trace, model parameters were varied in order to obtain an optimal fit.

The model was run with the average parameter values across a grid of possible injection protocols, with injection volume ranging from 30 to 300μL and injection time ranging from 0.1 to 5s. For each case, peak pressure and time required to reach a 1kPa threshold were recorded.

Experimentally measured peak pressure ranged from 68 to 88kPa. Pressure at the end of the 240s dwell ranged from 49 to 69kPa. There was no apparent difference between discs with and without endplates. Leakage of fluid following needle retraction was observed in all specimens. Experimental data were well fit by the analytical model, which predicted higher peak pressure and longer recovery time with increasing volume, from approximately 1500s at 30μL to nearly 3000s at 300μL. The model was nearly insensitive to injection rate.

The experimental data confirm pressurization of the disc during injection and injectate leakage resulting from insufficient recovery time. The model predicts that the time required to recover to below threshold leakage pressure is impractically long for both laboratory and clinical injection protocols. Similar behavior with and without endplates confirms that fluid flow is limited by permeability of the tissue itself, not the boundary conditions. Slow recovery is likely attributable to the fact that peak injection pressures were lower than the hydraulic swelling pressure of the nucleus pulposus, which has been reported to be approximately 140kPa.

Due to the high swelling pressure of the nucleus pulposus, it is unlikely that intradiscal injection procedures can be performed without substantial injectate leakage following needle retraction.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 68 - 68
1 Dec 2016
Nguyen D
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Background The minimum size required for a successful quadrupled hamstring autograft ACL reconstruction remains controversial. The risks of ACL re-tear in younger patients who tend to participate in a higher level of sports activity, and female athletes who have numerous predisposing factors, are poorly defined. Purpose To identify risk factors for graft re-tears within 2 years of ACL surgery. The hypotheses are that female sex, a smaller size graft, and younger patients will increase the odds of failure. Study Design Cohort Study. Level of evidence, 3.

A cohort of 503 athletes undergoing primary, autograft hamstring ACL reconstruction, performed by a single surgeon using the same surgical technique and rehabilitation protocol, between September-December 2012, was followed for a total duration of 2 years. Return to play was allowed between 6 and 12 months post-surgery upon completion of functional testing. Exclusion criteria included infections, revisions, double bundle techniques, multi-ligament injuries, non-compliance, BTB/allografts/hybrid grafts. Primary outcome consisted of binary data (ACL graft re-tear or no tear) as measured on physical exam (Lachman and pivot shift) and MRI. Multivariate logistic regression statistical analysis with model fitting was used to investigate the predictive value of sex, age, and graft size on ACL re-tear. Secondary sensitivity analyses were performed on the adolescent subgroup, age and graft size as categorical variables, and testing for interactions among variables. Sample size was calculated based on the rule of 10 events per independent variable for logistic regression.

The mean age of the 503 athletes was 27.5 (SD 10.6; range = 12–61). There were 235 females (47%) and 268 males (53%) with a 6 % rate of re-tears (28 patients; 17 females). Mean graft size was 7.9 (SD 0.6; range = 6–10). Univariate analyses of graft size, sex, and age only in the model showed that younger age (odds ratio [OR] = 0.86; 95% confidence interval [CI] = 0.80–0.93; P = .001] and smaller graft size (OR = 0.36; 95% CI = 0.18–0.70; P = .003) were significantly predictive of re-tear. Female sex was correlated with re-tear but was not significant (OR = 1.8; 95% CI = 0.84–3.97; P = .13). Multivariate analysis with all 3 variables in the model showed similar significant results. Graft size < 8 mm (OR = 2.95; 95% CI = 1.33–6.53; P = .008) and age < 25 (OR = 7.01; 95% CI = 2.40–20.53; P = .001) were significantly predictive of re-tear. Entire model was statistically significant (Omnibus test P = .001; Hosmer-Lemeshow statistic P = .68; Receiver Operating Curve [ROC] = 0.8).

Surgeons should counsel their patients who are female, younger than 25 and with a graft size less than 8 mm accordingly and consider modifying their surgical or rehabilitation techniques to mitigate these re-tear risks.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 117 - 117
1 May 2016
Kohan L Kerr D Farah S Field C Nguyen D
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Aim

Adverse tissue reactions have been a concern in relation to metal components, particularly in hip replacements. We look at a possible correlation between hip joint effusion and metal ion levels.

Materials and methods

56 patients,(42M, 14F) agreed to the study. All had metal-on-mental arthroplasties. Average age was 64.2 (SD 9.8). All patients were asymptomatic.

Ultrasound examination performed by one ultrasonographer, using a Sonosite M-Turbo machine with a C60X/5-2 MHz transducer.

Cobalt levels were assessed using an inductively coupled plasma mass spectrometer. Chromium levels were assessed using a graphite furnace atomic absorption spectrometer.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 120 - 120
1 Jan 2016
Kohan L Farah S Field C Nguyen D Kerr D
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There has recently been an increase in the number of hip replacement procedures performed through an anterior approach. Every procedure has a risk profile, and in the case of a new procedure or technique it is important to investigate the incidence of complications. The aim of this study is to identify the complications encountered in the first 100 patients treated with the minimally invasive anterior approach.

This is a case series of the first 100 hips treated and were assessed for complications. These were classified according to the severity and outcome [1]. The 100 hip comprised of 98 patients; 46 males and 52 females with an average operation age on 70.1 (±9.38) years. There were 2 bilateral procedures. Specific patient selection criteria were used. All complications occurred within one month of surgery. Complications such as fracture, deep vein thrombosis (DVT), cup malposition, femoral stem malposition, retained screw, excessive acetabular reaming and skin numbness were noted. Complications associated with fracture were characterized as either periprosthetic or trochanteric. Clinical outcome scores of SF36v2, WOMAC, Harris Hip and Tegner activity score were analysed at pre-operative, 6 months, 12 months 24 months and 36 months intervals.

A total of 13 early complications occurred. Of these 13 complications the most common complications were trochanteric fracture, 3 instances (3.00%), periprosthetic fracture, 2 (2.00%), DVT, 2 (2.00%), numbness, 2 (2.00%) and loosening. Other complications recorded were cup malposition, 1 (1.00%), femoral stem malpositon, 1 (1.00%), retained screw, 1 (1.00%) and excessive acetabular reaming, 1 (1.00%). All fractures occurred in patients over the age of 60 years.

Significant differences (p<0.05) were observed between all clinical outcomes measures pre-operatively and postoperatively (6, 12, 24 and 36 months). The unfamiliarity of the approach, however, increased operating time, and exposure problems, lead to trochanteric fracture.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 119 - 119
1 Jan 2016
Kohan L Farah S Field C Kerr D Nguyen D
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Introduction

Dissatisfaction with the posterior approach to total hip replacement has led to the anterior approach being adopted with enthusiasm in some areas.

Objectives

We aim to assess any difference between the 2 approaches and if so, the magnitude of this difference.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 451 - 451
1 Dec 2013
Nguyen D Burgett M Clarke I Halim T Donaldson T
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Damage to metal-on-metal bearings (MOM) has been varyingly described as “edge wear,” third-body abrasive wear and “rim-damage” (1–4). However, no distinction has been made between any of these proposed wear mechanisms. The goal of this study was to discover what features might differentiate between surface damage created by either 2-body or 3-body wear mechanisms in MOM bearings. The hypotheses were that surface damage created by impingement of the cup rim (2-body wear) would be i) linear on the micro-scale, ii) reveal transverse striations (in direction of the sliding rim), iii) have either no raised lip or have a single lip along one side of the track, and iv) have an asymmetrical surface profile across the track width.

Five cases with 28 mm MOM, five of 34–38 mm MOM, and five of 50–56 mm diameter were studied (N = 15). The main wear zone (MWZ) was measured in each MOM head and the number of 2-body wear tracks recorded in the non-wear (NWZ) and main wear zone (MWZ). Bearing damage was examined using a white-light interferometer (Zygo Newview 600; 5x lens) and a scanning electron microscope (Zeiss MA15). The depths and slopes were assessed across the width of the damage tracks.

Thirteen of the 15 MOM bearings showed wear tracks that exhibited all four of the hypothesized 2-body wear characteristics. These wear tracks will be referred to as “micro-segments”. While micro-segments visually appeared linear, microscopically they revealed a semi-lunar edge coupled with transverse striations leading to a linear edge. This indicated that during impingement episodes, the cup rim ploughed material from the CoCr surface at the semi-lunar edge (Fig. 1), thereby creating the abruptly raised lip on the linear edge of the track. This “snow plough effect” and its distinct edge effect can account for the asymmetrical surface profile. A different type of 2-body wear was identified and referred to as “furrows”. Furrows also visually appeared linear visually, but microscopically revealed longitudinal striations and a symmetrical surface profile (Fig. 2). Furrows had lips raised on both sides of the track, but not circumscribing the terminal ends of the track. Instead, the ends of the furrows are tapered smooth transitions to the articular surface.

Thus, 2-body tracks were found to be distinguishable from 3-body tracks (micro-grooves) and were classified as either micro-segments or furrows. Micro-segements supported hypotheses 1–3 and provided a clearer definition for hypothesis-4, while furrows only supported hypothesis 1. The divergence in features between micro-segments and furrows allude to different interactions between the bearing and cup rim that led to each type of track. While these data represent a small set of cases (n = 15) this evidence shows for the first time what was previously only suspected (2), that the CoCr rim can routinely create 2-body wear damage mechanisms in MOM femoral heads.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 137 - 137
1 Dec 2013
Nguyen D Burgett M Halim T Donaldson T Clarke I
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There is a consensus that impingement, subluxation, and dislocation are major risks that can lead to failure in total hip arthroplasty (1). As well as producing edge-wear, such clinical events also may create additional loads of particulate debris (2). It has been suggested that the release of metal debris with collateral damage on metal-on-metal (MOM) bearings creates a particularly severe abrasive wear, hitherto not understood, and recently termed ‘micro-grooving’ (3,4). Perhaps related to this micro-grooving, large surface depressions have also been observed. These we labeled ‘Dongas’, from the South African term for a steep-sided gully created by erosion. The goal of this study was to examine Dongas found on retrieved MOM bearings and to correlate factors such as cause of revision, MOM diameter and Donga locations with respect to regions of normal and stripe wear. Our hypotheses were: (1) Dongas will be most visible in non-wear zones (NWZ) adjacent to the main-wear zone boundary (MWZ), (2) the 28 mm MOM, being inherently less stable compared to large-diameter MOM, will show a higher Donga frequency and (3) patients with subluxation or dislocation complaints will reveal a higher Donga frequency.

Five cases with 28 mm MOM, five of 34–38 mm, and five of 50–56 mm diameter were studied (N = 15). The MWZ was measured in each MOM head and the number of NWZ and MWZ Dongas recorded. Bearing damage was examined using a white-light interferometer (Zygo; 5x lens).

Dongas were mainly elliptical in shape, but sometimes highly irregular. They were commonly circumscribed by raised lips (Fig. 1). Donga “trails” were also found, appearing as a linear series of similar-sized Dongas (Fig. 2). Donga trails exhibited some variability with raised lips either lining only the opposite sides or circumscribing most of the perimeter. The Dongas were commonly found in NWZ, with less than 20% found in MWZ. For this set of 15 MOM bearings, large-diameter bearings showed the largest number of Dongas and the greatest frequency of Dongas resulted from either loose or migrating cups.

The high occurrence of dongas in the non-wear zone (supporting hypothesis-1) may be a result of particles swept into the bearing interface (2,5). The size of the Dongas and their frequent association to local micro-grooves indicated that these were the impact sites of circulating particles. Such large surface depressions (40–200 μm) have not been described previously and may be unique to MOM bearings (3,4). The observation that Dongas were most prevalent in cases with loose or migrating cups left hypothesis-2 unsatisfied. The much higher incidence of Dongas in the large-diameter MOM was surprising and negated hypothesis-3. Overall these new data relating Dongas and micro-grooves gives new credence to a hitherto unsuspected 3rd-body abrasive wear mechanism due to repetitive subluxation or impingement.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 134 - 134
1 Sep 2012
Lindau T Bainbridge C Cohen B Kushner H Smith T Nguyen D Szczypa P Gerber R
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Introduction

Injectable collagenase clostridium histolyticum (CCH) is a minimally invasive non-surgical therapy with efficacy in correcting Dupuytren's contracture (DC). In the concurrently run JOINT I and JOINT II studies, designed to follow clinical practice, we evaluated the efficacy of ?5 CCH injections in patients with DC.

Methods

JOINT I and II were multicenter, 9-month, open-label studies in which DC patients with primary flexion deformities ?20° received ?3 CCH (0.58 mg) injections/joint (?5 injections/patient) at 30-day intervals into joints prioritized by extent of contracture. After the first injection, patients could opt to receive up to 2 additional injections in same cord or other cords regardless of outcome for the first joint. The primary endpoint was reduction in contracture to ?5° 30 days after the last injection. Data from JOINT I and II were pooled.