scholarly journals Treatment of post-meniscectomy knee symptoms with medial meniscus replacement results in greater pain reduction and functional improvement than non-surgical care

Author(s):  
Kenneth R. Zaslav ◽  
Jack Farr ◽  
Richard Alfred ◽  
R. Maxwell Alley ◽  
Michael Dyle ◽  
...  

Abstract Purpose Partial meniscectomy is a common orthopedic procedure intended to improve knee pain and function in patients with irreparable meniscal tears. However, 6–25% of partial meniscectomy patients experience persistent knee pain after surgery. In this randomized controlled trial (RCT) involving subjects with knee pain following partial meniscectomy, it was hypothesized that treatment with a synthetic medial meniscus replacement (MMR) implant provides significantly greater improvements in knee pain and function compared to non-surgical care alone. Methods In this prospective, multicenter RCT, subjects with persistent knee pain following one or more previous partial meniscectomies were randomized to receive either MMR or non-surgical care. This analysis evaluated the 1-year outcomes of this 2-year clinical trial. Patient-reported knee pain, function, and quality of life were measured using nine separate patient-reported outcomes. The primary outcomes were the pain subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) and the average of all five KOOS subscales (KOOS Overall). Treatment cessation was defined as permanent device removal in the MMR group and any surgical procedure to the index knee in the non-surgical care group. Results Treated subjects had a median age of 52 years old (range 30–69 years) and one or more previous partial meniscectomies at a median of 34 months (range 5–430 months) before trial entry. Among 127 subjects treated with either MMR (n = 61) or non-surgical care (n = 66), 11 withdrew from the trial or were lost to follow-up (MMR, n = 0; non-surgical care, n = 11). The magnitude of improvement from baseline to 1 year was significantly greater in subjects who received MMR in both primary outcomes of KOOS Pain (P = 0.013) and KOOS Overall (P = 0.027). Treatment cessation was reported in 14.5% of non-surgical care subjects and only 4.9% of MMR subjects (n.s.). Conclusion Treatment with the synthetic MMR implant resulted in significantly greater improvements in knee pain, function, and quality of life at 1 year of follow-up compared to treatment with non-surgical care alone. Level of evidence I.

2021 ◽  
Vol 9 (7_suppl4) ◽  
pp. 2325967121S0020
Author(s):  
Elliott Hershman ◽  
Brian McKeon ◽  
Christopher Kaeding ◽  
Richard Edelson ◽  
Jonathan Greenleaf ◽  
...  

Objectives: Arthroscopic partial meniscectomy (APM) is the most common surgical treatment for symptomatic, irreparable meniscal tears that do not improve with non-surgical care. For many patients, APM is associated with improvements in knee pain and function, but a subset of patients reports persistent or recurrent knee pain 1-2 years after APM surgery. Current treatment options for post-APM knee pain are limited, especially for patients considered too young for knee replacement. The polymeric medial meniscus implant mimics the biomechanical function of the natural medial meniscus and is intended to provide relief from pain and improved function in subjects with knee pain following APM. Two FDA-regulated clinical trials were conducted in the United States and pooled for analysis, to assess superiority of a synthetic medial meniscus implant to non-surgical care in treating persistent or recurrent knee pain following previous partial meniscectomy. The hypothesis was that the meniscus implant is superior to non-surgical care for improvements in composite measures of knee-related pain, function, and quality of life at 2 years of follow-up. Methods: 242 patients (176 investigational, 66 control) were treated in 2 prospective, concurrent clinical trials in the U.S.: a randomized controlled superiority trial (RCT) comparing the medial meniscus implant to non-surgical care (control) and a single-arm, implant-only trial. Eligible subjects had persistent knee pain and one or more previous partial meniscectomies at least 6 months before trial entry. Treated subjects returned for follow-up visits at 1.5 months, 6 months, 1 year, and 2 years. Patient-reported knee pain, function, and quality of life were assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The primary patient-reported outcomes were 2 KOOS subscales: KOOS Pain and KOOS Overall. KOOS success was defined as subjects who achieved either (1) KOOS Pain ≥86.1 at 2 years and KOOS Overall ≥86.2 at 2 years or (2) a ≥20-point improvement from baseline to 2 years in KOOS Pain and KOOS Overall, with KOOS Pain ≥40 at 2 years. Treatment cessation was defined as any subject who discontinued the per-protocol treatment by permanent implant removal (implant group) or any surgical procedure on the index knee (control group). Implant subjects who underwent subsequent surgical procedures on index knees (e.g. implant exchange) remained in the trial. The two treatment groups were well-matched, except for baseline KOOS Sports and Recreation. Statistical analyses adjusted for high vs low baseline KOOS Sports and Recreation using 2-factor analysis of variance (ANOVA) for continuous variables and 2x2 logistic regression for dichotomous variables. Results: Sixteen subjects (6.6%; 14 control, 2 implant) were lost to follow-up or withdrew from the study over 2 years. The magnitude of improvement from baseline to 2 years was significantly greater in the implant group compared to control for 5 of 6 KOOS subscales (Figure 1), including the primary outcomes of KOOS Overall and KOOS Pain (Figure 1A,B). The proportion of subjects who achieved KOOS success was significantly higher in the implant group (63.4%) than the control group (27.9%), which remained true with or without the adjustment for baseline KOOS Sports and Recreation ( P<.0001 in each case). Treatment cessation through 2 years was less frequent in the implant group (10.5%) compared to the control group (17.3%), but the difference was not statistically significant ( P=.19). Conclusions: Two-year results from 2 prospective, concurrent, US clinical trials demonstrate that the synthetic meniscus implant provides superior relief from post-APM knee pain when compared to treatment with non-surgical care alone. In addition, the magnitude of change from baseline to 2 years in the primary patient-reported outcomes and the rate of KOOS success significantly favored the implant group compared to the control group. Subjects in the implant group tended to discontinue treatment at a lower rate compared to subjects in the control group, but the difference was not statistically significant. Subjects treated with the implant who underwent a device exchange or repositioning procedure were able to continue treatment therapy with the medial meniscus implant. Overall, the implant group experienced superior improvements and outcomes at 2 years compared to subjects receiving non-surgical care alone.


2019 ◽  
Vol 101-B (3) ◽  
pp. 272-280 ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
W. T. A. van der Graaf ◽  
M. A. J. van de Sande ◽  
...  

Aims The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. Patients and Methods This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. Results A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years’ follow-up. Conclusion Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients’ daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272–280.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jake von Hintze ◽  
Mika Niemeläinen ◽  
Harri Sintonen ◽  
Jyrki Nieminen ◽  
Antti Eskelinen

Abstract Background The purpose of this study was to determine the mid-term clinical, radiographic and health-related quality of life (HRQoL) outcomes and define the survival rate in patients who had undergone revision total knee arthroplasty (TKA) using the single rotating hinged knee (RHK) design. Methods Between January 2004 and December 2013, 125 revision TKAs were performed at our institution using the single RHK implant. We conducted both a retrospective analysis of prospectively collected outcome data of these patients and a prospective follow-up study of all 39 living patients (41 knees). The follow-up phase included an optional extra follow-up visit, PROM questionnaires, and plain radiographs. Results The ten-year Kaplan-Meier survival rate of the revision RHK knees was 81.7% (95% CI 71.9–91.6%) with re-revision for any reason as the endpoint. Overall, 15 knees (12% of the total) underwent re-revision surgery during the follow-up. The median follow-up was 6.2 years (range, 0–12.7 years) post-operatively for the baseline group. One mechanical hinge mechanism-related failure occurred without any history of trauma or infection. At the time of the final follow-up, the majority of patients evinced a fairly good clinical outcome measured with patient-reported outcome measures and none of the components were radiographically loose. Conclusion We found that in patients undergoing complex revision TKA, fairly good functional outcome and quality of life can be achieved using an RHK implant. Further, it seems that in this type of patient cohort, revision TKA using an RHK implant relieves pain more than it improves ability to function. The NexGen® RHK design can be regarded as a suitable option in complex revision TKA.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Safstrom ◽  
T.J Jaarsma ◽  
L.N Nordgren ◽  
M.L Liljeroos ◽  
A.S Stomberg

Abstract Background Since healthcare systems are increasingly complex and often fragmented, continuity of care after hospitalization is a priority to increase patient safety and satisfaction. Aim Describe factors related to continuity of care in patients hospitalized due to cardiac conditions. Methods This cross-sectional multicenter study enrolled patients 6 weeks after hospitalization due to cardiac conditions. A total of 993 patients were included (mean age 72.2 (SD 10.4), males 66%) with AMI (35%), AF (25%), angina (21%) and HF (17.3%). Patients completed the Patient Continuity of Care Questionnaire, a questionnaire based on the definition that continuity of care is “the extent to which a series of health care services is experienced as connected and coherent and is consistent with a patient's health needs and personal circumstances”. The total score of the questionnaire ranges from 6 to 30, higher score indicating higher continuity and a score &lt;24 indicating insufficient continuity. Cronbach's alpha on the total PCCQ was 0.94. Correlations between PCCQ and quality of life, depression, anxiety, perceived control and health care utilization were estimated using spearman rang correlation. Results Insufficient continuity of care ranged between 47% to 59% in the different diagnosis groups, which the highest continuity in the AMI group and lowest in patients with atrial fibrillation. In patients hospitalized due to AMI (n=355, mean age 71 (± 11), 70% men), continuity of care was related to higher perceived control, higher quality of life, a good financial situation, being a man, no symptoms of anxiety or depression (ᚹ range 0.17–0.26 p≤0.002). A low score on the PCCQ were associated with follow-up visit to a nurse in primary care after hospitalization (ᚹ −0.12 p=0.033). In patients hospitalized due to angina (n=210, mean age 73 (± 9), 74% men), continuity of care was related to higher perceived control, higher quality of life and no depressive symptoms (ᚹ range between 0.20 and 0.26 p=0.005). In patients with AF, (n=255, mean age 71 (± 10.), 58% men), continuity of care was related to having had contact by telephone with a nurse-led AF clinic, higher perceived control, higher quality of life and not being depressed (ᚹ range between 0.14–0.25 p=0.03). In patients with HF, (n=173, mean age 77 (±8) 59% men), continuity was related to male ender, younger age, follow-up in a nurse-led HF clinic and not being anxious (ᚹ range between 0.16 and 0.22 p=0.004–0.047). Low total score on PCCQ correlated to having had telephone contact with nurse in primary care (ᚹ −0.24 p=0.002). Conclusion Almost half of all patient reported insufficient continuity of care. Perceived control, quality of life, and symptoms of depression were related to higher continuity of care in all diagnose groups except heart failure. Further, there was a correlation between continuity and follow-up visits or contact by telephone with nurse-led clinics in all diagnose groups except angina. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Medical Research Council of Southeast Sweden, Centre for Clinical Research Sörmland


2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
I Hovdenak Jakobsen ◽  
D Kjaer

Abstract   Esophageal and gastric cancers are aggressive diseases. Due to extensive treatment, many patients experience adverse effects such as dysphagia, dumping, pain, fatigue, fear of recurrence and depression—all negatively impacting quality of life (QoL). The purpose of this study is to develop and test a follow-up model for patients after surgery for esophageal and gastric cancer. The model targets handling of adverse effects and psychosocial distress, aiming at improving patients’ QoL and functional level. Methods Development of the model follows recognized principles for complex interventions by the Medical Research Counsil. Extensive patient involvement is included in the development process, by means of a national patient advisory board. The assumed effect of the new model will be tested in a national two-part prospective study, executed before and after national implementation of the model, in both parts including approximately200 patients. Participants will be recruited prior to surgery, and follow-up is one year. Patient-reported data will be collected pre-operatively, at 3, 6, 9 and 12 months postoperatively, along with clinical and sociodemographic data. Results Development of the follow-up model after surgery will be completed in august 2020 and inclusion of patients for the prospective study part one, before implementation of the model, will commence summer 2020. Conclusion The perspectives of this study may be crucial for future follow-up of esophageal and gastric cancer patients. First, the extensive patient involvement in developing the model will ensure a patient-centred approach to follow-up. And second, the follow-up studies will provide important and up-to-date knowledge about clinical and patient-reported outcomes in a population-based, national cohort.


2020 ◽  
Vol 22 (2) ◽  
pp. 146-150
Author(s):  
Mariana Lima da Costa Valente ◽  
Marcela Silva Costa ◽  
Paulo Marcos Bérgamo ◽  
Denise Tornavoi de Castro

Currently, aesthetics, and especially the smile, adds considerable social value. In this way, patients suffering from dental loss wish that their rehabilitation be performed quickly and safely. The aim of oral rehabilitation is to restore masticatory, phonetic, aesthetic and quality of life to the patient. The diagnostic step is one of the most important and relevant steps in establishing a correct treatment plan and, in this way, it is possible to obtain excellent results. The present study aimed to demonstrate the importance of diagnostic waxing in oral rehabilitation. Patient sought treatment at the Dental Prosthesis Specialization Course at Odonto School, due to complaints associated with aesthetics and function. To improve their quality of life, planning of case was carried out through diagnostic waxing and a prosthetic solution was proposed. At the end of treatment and during the follow-up of the case, the patient reported satisfaction and significant improvement in quality of life. It can be concluded that the diagnostic waxing presents customized solutions offering, through a previous study, an effective clinical resolution to the patient. Keywords: Mouth Rehabilitation. Dental Restoration, Temporary. Dental Restoration, Temporary. Resumo Atualmente, a estética, e em especial o sorriso, agregam um valor social considerável. Dessa forma, ao sofrerem a perda dental, os pacientes desejam que sua reabilitação seja realizada de forma rápida e segura. A reabilitação oral tem como objetivo devolver ao paciente a eficiência mastigatória, fonética, estética e a qualidade de vida. A etapa diagnóstica constitui um dos passos mais importantes e relevantes no estabelecimento de um correto planejamento do tratamento e, desta forma, torna-se possível obter resultados de excelência. O presente estudo teve como objetivo demonstrar a importância do enceramento diagnóstico na reabilitação oral. Paciente procurou tratamento no Curso de Especialização em Prótese Dentária da Odonto School, devido a queixas associadas a estética e função. Para melhorar sua qualidade de vida, foi realizado o planejamento do caso por meio do enceramento diagnóstico e uma solução protética foi proposta. Ao final do tratamento e durante o acompanhamento do caso, a paciente relatou satisfação e melhora significativa na qualidade de vida. Pode-se concluir que o enceramento diagnóstico apresenta soluções personalizadas oferecendo, por meio de estudo prévio, uma resolução clínica efetiva ao paciente. Palavras-chave: Reabilitação Bucal. Restauração Dentária Temporária. Prótese Dentária Temporária.


Author(s):  
Ilona Stolpner ◽  
Jörg Heil ◽  
Fabian Riedel ◽  
Markus Wallwiener ◽  
Benedikt Schäfgen ◽  
...  

Abstract Background Poor patient-reported satisfaction after breast-conserving therapy (BCT) has been associated with impaired health-related quality of life (HRQOL) and subsequent depression in retrospective analysis. This prospective cohort study aimed to assess the HRQOL of patients who have undergone BCT using the BREAST-Q, and to identify clinical risk factors for lower patient satisfaction. Methods Patients with primary breast cancer undergoing BCT were asked to complete the BREAST-Q preoperatively (T1) for baseline evaluation, then 3 to 4 weeks postoperatively (T2), and finally 1 year after surgery (T3). Clinicopathologic data were extracted from the patients’ charts. Repeated measures analysis of variance (ANOVA) was used to determine significant differences in mean satisfaction and well-being levels among the test intervals. Multiple linear regression was used to evaluate risk factors for lower satisfaction. Results The study enrolled 250 patients. The lowest baseline BREAST-Q score was reported for “satisfaction with breast” (mean, 61 ± 19), but this increased postoperatively (mean, 66 ± 18) and was maintained at the 1 year follow-up evaluation (mean, 67 ± 21). “Physical well-being” decreased from T1 (mean, 82 ± 17) to T2 (mean, 28 ± 13) and did not recover much by T3 (mean, 33 ± 13), being the lowest BREAST-Q score postoperatively and in the 1-year follow-up evaluation. In multiple regression, baseline psychosocial well-being, body mass index (BMI), and type of incision were risk factors for lower “satisfaction with breasts.” Conclusion Both the aesthetic/surgery-related and psychological aspects are equally important with regard to “satisfaction with breasts” after BCT. The data could serve as the benchmark for future studies.


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