Titanium and Other Metal Hypersensitivity Diagnosed by MELISA® Test: Follow-Up Study

This study is aimed at proving the clinical benefit of the MELISA® test in the minimization or complete elimination of health problems in patients with confirmed hypersensitivity to metals used for tissue replacements. A group of 305 patients aged 20-75 years with previously proven metal hypersensitivity (initial MELISA® test), mainly to titanium and then to another fifteen metals, was chosen from the database at the Institute of Dental Medicine. From these patients, a final group of 42 patients agreed to participate in the study, 35 of which were female and 7 were male. The patients completed a special questionnaire aimed at information regarding change of health status from their last visit and determining whether the results of the initial MELISA® test and recommendations based on it were beneficial for patients or not. They were clinically examined, and peripheral blood samples were taken to perform follow-up MELISA® tests. Questionnaire data was processed, and the follow-up MELISA® test results were compared with the results of the initial MELISA® tests. For statistical analysis, the Fisher’s exact test and paired T -test were used. Thirty-two patients reported that they followed the recommendations based on the results of the initial MELISA® tests, and of these, 30 patients (94%) confirmed significant health improvement. Six patients did not follow the recommendation, and from these, only one patient reported an improvement in his health problems. By comparison of the initial and follow-up MELISA® test results, it can be stated that the hypersensitivity to the given metal decreased or disappeared after the therapeutic interventions performed based on the initial MELISA® test results. The evaluation of the data obtained from patients in this study confirmed a significant clinical benefit of MELISA® test.

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A case report: Type II Abernethy malformation complicated with congenital polydactyly and enlargement of all cardiac chambers.

10.21203/rs.2.18514/v1 ◽

2019 ◽

Author(s):

Cheng Zhu ◽

Min Wang ◽

Qian Hao

Keyword(s):

Congenital Malformations ◽

Portacaval Anastomosis ◽

Test Results ◽

Abernethy Malformation ◽

Form And Function ◽

Laboratory Test Results ◽

Number Of Patients ◽

Patient Reported ◽

And Function

Abstract Background: Abernethy malformation is a kind of congenital malformation of portal vein system caused by abnormal portacaval anastomosis. It can be in combination with other congenital malformations. The major therapy of Abernethy malformation is surgery. There has been a limited number of patients since the first patient reported, leading to a limited view towards this kind of disease until now.Results: In August 2018 we treated a patient diagnosed with typeII Abernethy malformation complicated with both congenital polydactyly and enlargement of all cardiac chambers, which is extremely rare and can be a supplementary to the existing cases. Besides, the low white blood cell and platelet, the arrested megakaryocytic maturation and the positive platelet autoantibody in serum may result in misdiagnosis as immune thrombocytopenia, so we analyze the differential points between these two diseases. We treated this patient with silybin orally and advised him to make follow-up visits because of his mild liver function disorder, normal cardiac function and no other malformations or complications complicated. At the latest follow-up, we knew the condition of the patient was generally satisfactory, whether in terms of laboratory test results or his daily life experience.Conclusions: Because of some changes of spleen in form and function secondary to Abernethy malformation, in some cases, this disease has similarities with a part of blood diseases, which we should take into consideration for differential diagnosis, especially when other congenital malformations are found in combination at the same time. This case also suggests that simply conservative treatment with regular follow-up visits can be suitable for certain patients.

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Plasma citrulline levels as a biomarker for bowel toxicity in prostate stereotactic radiotherapy with or without pelvic nodal radiation.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.7_suppl.73 ◽

2019 ◽

Vol 37 (7_suppl) ◽

pp. 73-73

Author(s):

Ciaran Fairmichael ◽

Kelly M. Redmond ◽

Ciara Lyons ◽

Sarah R. Stevenson ◽

Sarah O. Osman ◽

...

Keyword(s):

Clinical Trial ◽

Small Bowel ◽

Stereotactic Radiotherapy ◽

Summary Score ◽

Pelvic Radiotherapy ◽

Exact Test ◽

Plasma Citrulline ◽

Patient Reported ◽

To Receive

73 Background: Plasma levels of citrulline, an amino acid, are derived mainly from small bowel enterocytes. Decreased levels occur in a range of bowel conditions and citrulline has been proposed as a biomarker of bowel toxicity in pelvic radiotherapy. In a prospective study, we identify no correlation between plasma citrulline and toxicity in men receiving prostate stereotactic radiotherapy randomized to receive either pelvic nodal irradiation or not. Furthermore, citrulline levels were not significantly different between these two groups. Methods: As part of an approved clinical trial, men with intermediate to high risk prostate cancer were randomised 1:1 to prostate only or prostate + pelvic nodal radiotherapy, delivered with a rectal spacer gel in situ. The prostate and proximal seminal vesicles received 40 Gy in 5 fractions. Those randomised to the pelvic nodal arm also received 25 Gy in 5 fractions to pelvic nodes. Citrulline was measured at 10 points during treatment – consent, before fraction 1, 1 and 24 hours following fraction 1, prior to each fraction 2 – 5 and at 6 weeks’ and 3 months’ follow up. Bowel toxicity was measured by EPIC patient reported scores. Results: 16 men with follow up of at least 3 months (median 9, maximum 18 months) were analysed. Reported toxicity was significantly higher in the prostate and pelvis arm: 5 of 9 men showed a decrease in EPIC bowel domain summary score of 10 points or more compared to 0 of 7 in the prostate-only arm (p = 0.0337, two tailed Fisher’s exact test). No significant correlation between toxicity and citrulline levels was seen, nor did citrulline vary significantly between arms or fall as treatment progressed. Data analysis for a further 8 men already recruited to the study is ongoing. Conclusions: Toxicity was more commonly reported by men randomised to receive pelvic radiotherapy, suggesting that the small bowel irradiated in pelvic fields plays a role in bowel toxicity experienced during stereotactic radiotherapy. Citrulline levels showed no significant correlation with toxicity or radiation dose to small bowel. We propose that citrulline is not a useful biomarker of small bowel toxicity in this setting. Clinical trial information: NCT03253978.

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Intramuscular versus ultrasound-guided intratenosynovial glucocorticoid injection for tenosynovitis in patients with rheumatoid arthritis: a randomised, double-blind, controlled study

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2016-209840 ◽

2016 ◽

Vol 76 (4) ◽

pp. 666-672 ◽

Cited By ~ 8

Author(s):

Mads Ammitzbøll-Danielsen ◽

Mikkel Østergaard ◽

Viktoria Fana ◽

Daniel Glinatsi ◽

Uffe Møller Døhn ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Isotonic Saline ◽

Group Versus ◽

Controlled Study ◽

Fisher Exact Test ◽

Double Blind ◽

Exact Test ◽

Patient Reported ◽

Registration Number

ObjectiveThe aim of this study was to compare the efficacy of intramuscular versus ultrasound (US)-guided intratenosynovial glucocorticoid injection in providing disease control after 2, 4 and 12 weeks in patients with rheumatoid arthritis(RA) with tenosynovitis.MethodsFifty patients with RA and tenosynovitis were randomised into two double-blind groups: (A) ‘intramuscular group’, receiving intramuscular injection of betamethasone and US-guided intratenosynovial isotonic saline injection and (B) ‘intratenosynovial group’ receiving saline intramuscularly and US-guided intratenosynovial betamethasone injection. All patients were in stable disease-modifying anti-rheumatic drug treatment prior to and during the study. Patients were excluded, and considered non-responders, if any treatments were altered during the follow-up period. ‘US tenosynovitis remission’, defined as US tenosynovitis grey-scale score ≤1 and colour Doppler score=0, was assessed at week 4 (primary outcome), and weeks 2 and 12, using non-responder imputation for missing data.ResultsUS tenosynovitis remission at week 4 was achieved in 25% (6/24) in the ‘intramuscular group’ versus 64% (16/25) in the ‘intratenosynovial group’, that is, a difference of −39 percentage point (pp) (CI −65pp to −13pp), Fisher exact test p=0.001. Corresponding values for the ‘intramuscular group’ versus the ‘intratenosynovial group’ at 2 and 12 weeks were 21% (5/24) versus 48% (13/25), that is, a difference of −27pp (CI −53pp to −2pp), p=0.072 and 8% (2/24) versus 44% (11/25), that is, difference of −36pp (−58pp to −13pp), p=0.003. Most US, clinical and patient-reported scores improved more in the ‘intratenosynovial group’ at all follow-up visits.ConclusionsIn this randomised double-blind clinical trial, patients with RA and tenosynovitis responded significantly better to US-guided intratenosynovial glucocorticoid injection than to intramuscular glucocorticoid injection, both at 4 and 12 weeks follow-up.Trial registration numberEudraCT nr: 2013-003486-34.

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Inner Prepuce Preserving ‘Bird-Winged Coronal-Collar Skin ReArrangement’ Modification of Tip Urethroplasty

10.47363/jdcrs/2020(1)105 ◽

2020 ◽

pp. 1-4

Author(s):

Prabudh Goel ◽

◽

Jile Dar Rawat ◽

Piyush Kumar ◽

◽

...

Keyword(s):

Ventral Surface ◽

Control Group ◽

Test Results ◽

Penile Shaft ◽

Modified Technique ◽

Exact Test ◽

Tubularized Incised Plate ◽

Fischer Exact Test

Objective: To describe the ‘Bird-Winged Coronal-Collar Skin re-arrangement modification’ of the Tubularized Incised Plate (TIP) urethroplasty to preserve the inner preputial skin on the ventral surface of the penile shaft. Material and Method: Study Group: Prospective review of the results of a single surgeon with Bird-Winged Coronal-Collar skin re-arrangement modification of TIP urethroplasty (n=111; mean age 4.9 years) of distal (n=76) and mid-penile (n-35) hypospadias (mean follow-up 37 months). Control Group: Retrospective review of a single surgeon’s results of distal and mid-penile hypospadias repair with standard TIP urethroplasty (2007-11). Outcome parameters (to compare non-inferiority of the modified technique): Urethro-cutaneous fistula (UCF) at voiding trial and follow-up at 3 months, wound infection, complete dehiscence, local edema, meatal stenosis and quality of urinary stream. Statistical analysis was done with the Fischer Exact Test. Results: With this technique, the authors could provide an inner preputial cover on the ventral/ ventro-lateral aspects of distal penile shaft in all but one patient (complete dehiscence). The results of ‘bird-winged coronal-collar skin re-arrangement’ modification were not-inferior/ comparable to those of standard TIP urethroplasty. Conclusions: The modification is technically feasible and reproducible and the overall results of urethroplasty were not inferior to the standard TIPS procedure.

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Association of improved survival (OS) and tumor control (TC) with interleukin-2 (IL2) with development of immune-related events (IREs): Data from the PROCLAIMSM registry.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.9528 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 9528-9528

Author(s):

Brendan D. Curti ◽

Gregory A. Daniels ◽

David F. McDermott ◽

Joseph Clark ◽

Howard Kaufman ◽

...

Keyword(s):

Interleukin 2 ◽

Rank Test ◽

Tumor Control ◽

Test Results ◽

Exact Test ◽

Log Rank Test ◽

Kaplan Meier ◽

Long Term Impact

9528 Background: IREs are associated with immunotherapy (IT) for cancer and while reports suggest improvement in TC and OS with induced IREs, the long-term impact is unclear. IL2 has been the major IT for patients (pts) with renal cell carcinoma (RCC) and melanoma (MM) since 1992. We evaluated IREs reports in the PROCLAIMSM data base (2008-2016) of IL2-treated pts. Methods: Reports on 614 (MM) and 843 (RCC) pts were queried for IREs. IREs were categorized as occurring before, during, or after IL-2 and related to any checkpoint inhibitor (CPI). TC (CR+PR+SD) was compared between no IRE and IRE, using Fisher’s exact test. OS curves were estimated by Kaplan-Meier method, and comparison of no IRE/before IL2 with during/after IL2, was analyzed by log-rank test. Results: With a median (med) follow-up of 3.5+ years (range 1-8+ year), 140 IREs were reported in 118 pts (9.6% of all PROCLAIMSM pts): 93 (15%) in MM; 47 (5.6%) in RCC. 25 IREs were prior to IL2; 13 IREs were during IL2; 102 were after IL2. Of the latter 102, 31 were after IL2 and after subsequent CPI; 71 were attributed to IL2 only; and in 13, IREs were due to either IL2 or CPI. TC was 73% for IRE group vs 56% for no IRE group (p = 0.0054). OS was significantly greater for IRE group during/after IL2 compared to no IRE/before IL2 in MM, med 46 months (mo) vs 18 mo (p = 0.0001) and in RCC, med 61 mo vs 43 mo (p = 0.0196), independent of CPI IREs. Med # of IL2 doses was 19 in no IRE group, 39 in IRE during IL2 group, and 25 in IRE after IL2 group. IL2-related IREs were primarily vitiligo and thyroid dysfunction (70% of IL2 IREs), with limited further impact, while CPI-related IREs were often serious, requiring intervention (hypophysitis, colitis, hepatitis, uveitis) (52% of CPI IREs) and possibly chronic management. Conclusions: IREs following IL2 are associated with improved TC and OS. IREs resulting from IL2 and from CPIs are qualitatively different and likely reflect different mechanisms of action of immune activation and response.

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Patient-reported outcomes (PROs) from the phase III IMpassion130 trial of atezolizumab (atezo) plus nabpaclitaxel (nP) in metastatic triple-negative breast cancer (mTNBC).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.1067 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 1067-1067 ◽

Cited By ~ 3

Author(s):

Sylvia Adams ◽

Veronique Dieras ◽

Carlos H. Barrios ◽

Eric P. Winer ◽

Andreas Schneeweiss ◽

...

Keyword(s):

Breast Cancer ◽

Physical Function ◽

Clinical Benefit ◽

Phase Iii ◽

Role Function ◽

End Of Treatment ◽

Patient Reported ◽

Clinical Trial Information ◽

Better Than

1067 Background: In the IMpassion130 study in 1L mTNBC (N = 902), PFS with atezo + nP was significantly better than with placebo (P) + nP in ITT (HR, 0.80) and PD-L1 IC+ (HR, 0.62) patients (pts). Clinically meaningful OS improvement (HR, 0.62) was also seen in PD-L1+ pts. PROs were used to document pt perspectives on overall clinical benefit of atezo + nP. Methods: Pts received either atezo 840 mg or P q2w + nP 100 mg/m2 on days 1, 8 and 15 of each 28-day cycle until disease progression or intolerance. Pts completed the EORTC QLC-C30 and breast cancer module (QLQ-BR23) on day 1 of each cycle, at end of treatment (Tx) and q4w during follow-up for 1 y. Time to deterioration (TTD; first ≥ 10-point decrease from baseline [BL] held for 2 cycles) in HRQoL was a pre-defined secondary endpoint. Exploratory endpoints included TTD in function, and mean and mean change from BL scores (changes ≥ 10 considered clinically meaningful) in HRQoL, function and disease/Tx-related symptoms. Results: BL completion was 92% (QLQ-C30) and 89% (QLQ-BR23) and remained > 80% through Cycle 20 in both ITT and PD-L1 IC+ pts. No differences in median TTD in HRQoL (ITT: HR, 0.97 [95% CI: 0.80, 1.18]; PD-L1 IC+: HR, 0.94 [95% CI: 0.69, 1.28]), physical function (ITT: HR, 1.04 [95% CI: 0.86, 1.26]; PD-L1 IC+: HR, 1.02 [95% CI: 0.76, 1.37]) or role function (ITT: HR, 1.01 [95% CI: 0.83, 1.22]; PD-L1 IC+: HR, 0.77 [95% CI: 0.57, 1.04]) were observed between arms in either population. Mean scores at BL for HRQoL (ITT: 66.0 [atezo + nP] vs 64.3 [P + nP]; PD-L1 IC+: 67.5 vs 65.0), physical function (ITT: 80.4 vs 79.2; PD-L1 IC+: 82.8 vs 79.4) and role function (ITT: 72.7 vs 71.0; PD-L1 IC+: 73.7 vs 71.7) were similar between arms and throughout the course of Tx. In both arms, HRQoL, physical and role function, and Tx symptoms (fatigue, diarrhea, nausea, vomiting) were stable during Tx, with no clinically meaningful changes seen until pts discontinued Tx. Conclusions: PRO data suggest that atezo + nP was tolerable and similar to nP alone in maintaining HRQoL and day-to-day function relative to BL. This confirms atezo + nP had clinical benefit without compromising HRQoL, physical and role function, or worsening Tx symptoms vs P + nP in 1L mTNBC. Clinical trial information: NCT02425891.

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Patient-Reported Efficacy 6 Months After a 4-Week Rehabilitation Intervention in Individuals With Chronic Ankle Instability

Journal of Sport Rehabilitation ◽

10.1123/jsr.2016-0044 ◽

2017 ◽

Vol 26 (4) ◽

pp. 250-256 ◽

Cited By ~ 2

Author(s):

Cynthia J. Wright ◽

Shelley W. Linens

Keyword(s):

Ankle Instability ◽

Controlled Trial ◽

Chronic Ankle Instability ◽

Fisher Exact Test ◽

Global Rating ◽

Exact Test ◽

Outcome Measurements ◽

Patient Reported ◽

History Of

Objective:To track the patient-reported efficacy of a 4-wk intervention (wobble board [WB] or resistance tubing [RT]) in decreasing symptoms of chronic ankle instability (CAI) at 6 mo postintervention (6PI) as compared with immediately postintervention (IPI).Design:Randomized controlled trial.Participants:Fourteen of 21 participants (66.7%) responded to an electronic 6-m follow-up questionnaire (age 19.6 ± 0.9 y, height 1.63 ± 0.18 m, weight 70.5 ± 16.3 kg; 2 male, 12 female; 5 WB, 9 RT). All participants met CAI criteria at enrollment, including a history of ankle sprain and recurrent episodes of giving way.Interventions:Participants completed either RT or WB protocols, both 12 sessions over 4 wk of progressive exercise. WB sessions consisted of five 40-s sets of clockwise and counterclockwise rotations. RT sessions consisted of 30 contractions against resistance tubing in each of 4 ankle directions.Main Outcome Measurements:Patient-reported symptoms of “giving way” preintervention and at 6PI, global rating of change (GRC) frequencies at IPI and 6PI, and resprains at 6PI were reported descriptively. Changes in global rating of function (GRF) and giving way were compared using Wilcoxon tests, while GRC was compared with Fisher exact test.Results:All participants reported giving way preintervention, only 57.1% reported giving way at 6PI. Resprains occurred in 21.4% of participants. Giving-way frequency (P = .017), but not GRF or GRC (P > .05), was significantly different at IPI vs 6PI.Conclusions:Simple 4-wk interventions maintained some but not all improvements at 6PI. At least 42.9% of participants would no longer meet the current study’s CAI inclusion criteria due to a reduction in giving way.

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Endoscopic Repair of Partial Thickness Under-Surface Tears of The Abductor Tendon (pusta): Clinical Outcomes with Minimum Two-year Follow-up

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967118s00111 ◽

2018 ◽

Vol 6 (7_suppl4) ◽

pp. 2325967118S0011

Author(s):

David Edward Hartigan ◽

Itay Perets ◽

Sherwin S.W. Ho ◽

John P. Walsh ◽

Leslie Yuen ◽

...

Keyword(s):

Patient Satisfaction ◽

Clinical Benefit ◽

Gluteus Medius ◽

Partial Thickness ◽

Patient Satisfaction Scores ◽

Substantial Clinical Benefit ◽

Patient Reported ◽

Average Patient ◽

Minimally Clinical Important Difference

Objectives: To report the minimum two-year outcomes of trans-tendinous repairs of Partial Thickness Undersurface Tears of the Abductor (PUSTA) tendon using patient reported outcomes (PROs), visual analog scale (VAS), and patient satisfaction scores. Methods: All patients who underwent endoscopic trans-tendinous gluteus medius repair between October 2009 and May 2013 at one institution were prospectively evaluated. Exclusion criteria consisted of less than two-year follow-up, previous hip surgery, inflammatory arthritis, open surgery, full thickness abductor tear, and worker’s compensation patients. All patients had a documented pre-operative physical exam with strength testing (0-5) and observation of their gait. Patient satisfaction and PRO scores were recorded preoperatively, at 3 months postoperatively, and annually thereafter. The PRO scores collected were mHHS, HOS-ADL, HOS-SSS, NAHS, and VAS. Preoperative strength and gait were compared to latest follow-up. Results: There were 25 patients that fit our criteria. Significant improvement in PRO scores were demonstrated for mHHS, HOS-ADL, HOS-SSS, NAHS, and VAS from 54.9-76.2, 50.2-80.6, 30.1-67.3, 51.9-82.4, and 7.1-2.7 respectively (p<0.001). There were 11 patients with objective weakness prior to surgery; seven of these patients moved up at least one strength grade by final follow-up. There were 14 patients who had a Trendelenbrug gait pre-operatively, 12 of them had a normal gait at latest follow-up (p-<0.001). Average patient satisfaction was 7.5. There were no revision surgeries, and no complications noted. Conclusion: PUSTA lesions can be treated successfully with endoscopic trans-tendinous repair preserving the intact attachment of superficial fibers of the gluteus medius. We recommend this treatment for partial undersurface tears recalcitrant to non-operative treatment, as patients demonstrated clinical benefit at greater than 2 years follow up that exceeds substantial clinical benefit and minimally clinical important difference.

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Attitudes of patients towards cancer clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.741 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 741-741

Author(s):

Olubukola Ayodele ◽

Mateen Akhtar ◽

Mathew Chad Eastwood ◽

Aiste Linkeviciute-Koneko ◽

Niamh M. Keegan ◽

...

Keyword(s):

Clinical Trials ◽

University Hospital ◽

Cancer Clinical Trials ◽

Summary Statistics ◽

Test Results ◽

Exact Test ◽

Patient Awareness ◽

New Drug ◽

New Treatment

741 Background: Older patients (pts) with cancer are under-represented in clinical trials (CTs). To better understand the causes for low accrual rates, the pts perspective must be explored. Objectives: To determine the attitudes of Irish pts towards enrolment into cancer CTs and in particular, the differences between the attitudes of older and younger pts. Methods: Pts with a gastrointestinal cancer, receiving treatment or in follow-up in University Hospital Waterford were eligible. Pts completed a self-dministered questionnaire comprising three sections: attitudes towards CT participation, reasons to participate, and reasons to decline participation. Pts were given three CT scenarios and were asked if they would participate: these included a cancer prevention/screening CT; a CT comparing standard to new treatment and a trial of a new drug where no standard exists. Summary statistics were used to describe the respondents. Differences between the groups were investigated using the Fishers exact test. Results: From March 2014, 69 pts were accrued, 31 <65 yrs (32-64) and 38 ≥65 yrs (65–85). Five (16%) younger and 3 (8%) older pts had been or were actively enrolled on a CT (p=0.45). An additional 4 (17%) younger and 5 (13%) older pts were invited to participate in a CT, all of whom declined. No patient in either group had actively enquired about CT availability. For the CT scenarios, 22 (71%) younger vs. 22 (58%) older pts would participate in a prevention/screening CT (p=0.32); 14 (45%) vs. 19 (50%) for standard vs. new drug CT (p=0.81), and 23 (74%) vs. 31 (82%) for a CT where no standard exists (p=0.56). The most common reasons to participate in a CT included the potential to feel better, reported in 100% of younger and older pts, the potential to live longer (100% vs. 92%) and the potential to help others (97% vs 89%). Age was deemed an important consideration in 20 (65%) younger and 25 (66%) older pts. Conclusions: The attitudes of older and younger pts to cancer CTs are similar. Physician barriers and availability of appropriate studies impact accrual of both older and younger cancer pts into trials. No patient in this study actively sought out a CT, suggesting a need for better patient awareness and education. This study is ongoing and updated results will be presented.

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Establishing the Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient Acceptable Symptomatic State following Primary Medial Patellofemoral Ligament Reconstruction

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120s00461 ◽

2020 ◽

Vol 8 (7_suppl6) ◽

pp. 2325967120S0046

Author(s):

Hailey Huddleston ◽

Neal Naveen ◽

Taylor Southworth ◽

Benedict Nwachukwu ◽

Brian Cole ◽

...

Keyword(s):

Clinical Benefit ◽

Surgical Procedure ◽

Predictive Power ◽

Medial Patellofemoral Ligament ◽

Minimal Clinically Important Difference ◽

Mpfl Reconstruction ◽

Clinically Important Difference ◽

Substantial Clinical Benefit ◽

Patient Reported

Objectives: Medial patellofemoral ligament (MPFL) reconstruction is an effective surgical procedure for patients with recurrent lateral dislocations. Outcome measurements can identify the success of a surgical procedure but are shifting away from absolute values or deltas of patient-reported outcomes (PROs) towards the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS), representing the smallest clinical improvement that patients perceive as important, the threshold at which patients notice a considerable improvement, and patient satisfaction with their outcome, respectively. To our knowledge no prior study has defined these thresholds in MPFL reconstruction patients. Methods: An institutional database was reviewed for patients who underwent primary MPFL reconstruction between August 2015 to February 2018 with a minimum 6-month follow-up. IKDC, Kujala and KOOS were administered to all patients pre-operatively and at 6-months and 1-year post-operatively. An anchor-based approach with a receiver-operator curve/area under the curve analysis using the Youden index was performed to calculate the MCID, SCB and PASS. The predictive power was determined to be acceptable with AUC≥70% and excellent with AUC≥80%. Results: From 2015 to 2018, 93 of 162 patients (mean age 23.7±10.1 years; 25 males, 68 females) completed for 6-month follow-up. At 6-months follow-up, SCB and PASS were defined with acceptable predictive power for all scores listed, while MCID achieved this for KOOS pain and sports subscores only (Table 1). At 1-year follow-up, SCB and PASS were each defined with acceptable predictive power for all scores listed, while MCID achieved this mark for KOOS pain and quality of life subscores as well as both Kujala scales. Conclusion: This study establishes MCID, SCB and PASS for IKDC, Kujala, and KOOS subscores at 6-months and 1-year postoperatively with excellent predictive power for 19/23 PROMs investigated at 1-year. These findings represent important benchmarks in patients undergoing primary MPFL reconstruction.

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