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The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol.

ABSTRACT: Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis. The incidence of hip replacement operations is expected to increase due to the growing elderly population. Overall, the posterior approach and lateral approach are the two most commonly used approaches for hip replacement operations. The posterior approach is associated with an increased risk of revision due to dislocations, and some studies have shown that the lateral approach is associated with reduced patient-reported outcomes, including physical function and pain; however, this has not been investigated in a randomised controlled trial with a twelve-month follow-up. We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year.The trial is a prospective, double blinded, parallel-group controlled trial with balanced randomisation [1: 1]. Patients with hip osteoarthritis scheduled for hip replacement surgery, aged 45-70 years, will be consecutively recruited and randomised into two groups. Group A will receive hip replacement using the posterior approach, and Group B will receive hip replacement using the lateral approach. The primary end-point for assessing the outcome of the two interventions will be twelve months after surgery. Follow-up will also be performed after three and six months. The primary outcome is Hip Disability and Osteoarthritis Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L). Explorative outcomes include physical function test, 3D-gait-analysis and muscle strength.To our knowledge, this is the first randomised controlled trial comparing the posterior approach with the lateral approach with patient reported outcome as the primary outcome and with a twelve-month follow-up.Clinicaltrial.gov: NCT01616667.

SUBMITTER: Rosenlund S

PROVIDER: S-EPMC4216831 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol.

Rosenlund Signe S Broeng Leif L Jensen Carsten C Holsgaard-Larsen Anders A Overgaard Søren S

BMC musculoskeletal disorders 20141027

<h4>Background</h4>Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis. The incidence of hip replacement operations is expected to increase due to the growing elderly population. Overall, the posterior approach and lateral approach are the two most commonly used approaches for hip replacement operations. The posterior approach is associated with an increased risk of revision due to dislocations, and some stud ...[more]

PMID: 25345483

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Project description:BACKGROUND:The Hip disability and Osteoarthritis Outcome Score (HOOS) is a frequently used patient-reported outcome measure (PROM) for assessment of hip disorders and treatment effects following hip surgery. The objective of the study was to translate and adapt the Hip disability and Osteoarthritis Outcome Score (HOOS) into Polish and to investigate the psychometric properties of the HOOS in patients with osteoarthritis undergoing total hip replacement (THR). MATERIALS AND METHODS:The Polish version of the HOOS was developed according to current guidelines. Patients completed the HOOS, Short Form 36 Health Survey (SF-36), the visual analogue scale (VAS) for pain and the global perceived effect (GPE) scale. Psychometric properties including interpretability (floor/ceiling effects), internal consistency (Cronbach's alpha), test-retest reliability (intra-class correlation coefficient, ICC), convergent construct validity (a priori hypothesized Spearman's correlations between the HOOS subscales, the generic SF-36 measure and the VAS for pain) and responsiveness (effect size, association between the HOOS and GPE scores) were analyzed. RESULTS:The study included 157 patients (mean age 66.8?years, 54% women). Floor effects were found prior to THR for the HOOS subscales Sports and Recreation and Quality of Life. The Cronbach's alpha was over 0.7 for all subscales indicating satisfactory internal consistency. The test-retest reliability was good for the HOOS subscale Pain (0.82) and excellent for all other subscales with ICCs ranging from 0.91 to 0.96. The minimal detectable change ranged from 12.0 to 26.2 on an individual level and from 1.4 to 3.0 on a group level. Seven out of eight a priori hypotheses were confirmed indicating good construct validity. Responsiveness was high since the expected pattern of effect sizes in all subscales was found. CONCLUSIONS:The Polish version of the HOOS demonstrated good reliability, validity and responsiveness for use in patient groups having THR.

Project description:Reduced external knee adduction moments in the second half of stance after total hip replacement have been reported in hip osteoarthritis patients. This reduction is thought to shift the load from the medial to the lateral knee compartment and as such increase the risk for knee osteoarthritis. The knee adduction moment is a surrogate for the load distribution between the medial and lateral compartments of the knee and not a valid measure for the tibiofemoral contact forces which are the result of externally applied forces and muscle forces. The purpose of this study was to investigate whether the distribution of the tibiofemoral contact forces over the knee compartments in unilateral hip osteoarthritis patients 1 year after receiving a primary total hip replacement differs from healthy controls. Musculoskeletal modeling on gait was performed in OpenSim using the detailed knee model of Lerner et al. (2015) for 19 patients as well as for 15 healthy controls of similar age. Knee adduction moments were calculated by the inverse dynamics analysis, medial and lateral tibiofemoral contact forces with the joint reaction force analysis. Moments and contact forces of patients and controls were compared using Statistical Parametric Mapping two-sample t-tests. Knee adduction moments and medial tibiofemoral contact forces of both the ipsi- and contralateral leg were not significantly different compared to healthy controls. The contralateral leg showed 14% higher medial tibiofemoral contact forces compared to the ipsilateral (operated) leg during the second half of stance. During the first half of stance, the lateral tibiofemoral contact force of the contralateral leg was 39% lower and the ratio 32% lower compared to healthy controls. In contrast, during the second half of stance the forces were significantly higher (39 and 26%, respectively) compared to healthy controls. The higher ratio indicates a changed distribution whereas the increased lateral tibiofemoral contact forces indicate a higher lateral knee joint loading in the contralateral leg in OA patients after total hip replacement (THR). Musculoskeletal modeling using a detailed knee model can be useful to detect differences in the load distribution between the medial and lateral knee compartment which cannot be verified with the knee adduction moment.

Project description:BackgroundCompetition-promoting reforms and economic incentives are increasingly being introduced worldwide to improve the performance of healthcare delivery. This study considers such a reform which was initiated in 2009 for elective hip replacement surgery in Stockholm, Sweden. The reform involved patient choice of provider, free establishment of new providers and a bundled payment model. The study aimed to examine its effects on hip replacement surgery quality as captured by patient reported outcome measures (PROMs) of health gain (as indicated by the EQ-5D index and a visual analogue scale (VAS)), pain reduction (VAS) and patient satisfaction (VAS) one and six years after the surgery.MethodsUsing patient-level data collected from multiple national registers, we applied a quasi-experimental research design. Data were collected for elective primary total hip replacements that were carried out between 2008 and 2012, and contain information on patient demography, the surgery and PROMs at baseline and at one- and six-years follow-up. In total, 36,627 observations were included in the analysis. First, entropy balancing was applied in order to reduce differences in observable characteristics between treatment groups. Second, difference-in-difference analyses were conducted to eliminate unobserved time-invariant differences between treatment groups and to estimate the causal treatment effects.ResultsThe entropy balancing was successful in creating balance in all covariates between treatment groups. No significant effects of the reform were found on any of the included PROMs at one- and six-years follow-up. The sensitivity analyses showed that the results were robust.ConclusionsCompetition and bundled payment had no effects on the quality of hip replacement surgery as captured by post-surgery PROMs of health gain, pain reduction and patient satisfaction. The study provides important insights to the limited knowledge on the effects of competition and economic incentives on PROMs.

Project description:BackgroundSupercapsular Percutaneously Assisted total hip arthroplasty (SuperPATH approach) is a relatively new minimal invasive approach which has been associated with encouraging postoperative outcomes. The aim of this study is to compare the minimal invasive (MIS) SuperPATHapproach with the standard modified Hardinge approach at the base of muscle damage due to serum markers, functional results and other perioperative and postoperative data.Material and methodsForty eight (48) consecutive patients undergone primary total hip arthroplasty (THA) by the same surgeon (GD), were enrolled in our study. From this study population, the modified Hardinge approach was performed in 23 patients and the SuperPATH approach was performed in 25 patients. Soft tissue impairment was studied based on three representative markers, C-reactive-protein (CRP) and two enzymes, creatine kinase (CK) and lactate dehydrogenase (LDH). We measured these markers 10 min after surgery, on 1st and 2nd postoperative day. The levels of the perceived pain were evaluated according to the Visual Analog Scale/Numerical Rating Scale (VAS/NRS) score which was registered 6 h, 12 h, 1 day and 2 days postoperatively. The functional and clinical evaluation of the patients was achieved with Harris Hip Score (HHS), Charnley's Hip score, EuroQol (EQ-5D)-(EQ-100), Patient Health Questionnaire (PHQ-9) and neuropathic pain questionnaire (DN-4) 6 months and 1 year postoperatively. The rest of the collected data included patient's age, gender, body mass index (BMI), other comorbitities, the American Society of Anesthiologists score (ASA), Charlson Index score, the pre-operative diagnosis, implant positioning through radiographic evaluation, the type of anesthesia, the days of hospitalization, the operating time, incision length, blood loss and blood transfusion requirements and complication rates.ResultsSuperPATH approach was related with statistically considerable lower levels of CRP at 10 min (p = 0,001) and at 24 h (p = 0,047) postoperatively, as well as lower LDH levels in all time points postoperatively. It was also associated with shorter incision length (p < 0.001), longer operating time (p < 0.001), higher mean cup inclination p < 0.001, decreased postoperative pain levels the first 6 and 12 h (p < 0.001) and relatively better clinical and functional results 6 months after surgery, but not at 12 months.ConclusionOur study revealed some advantages in favor of the SuperPATH approach comparing with the standard modified Hardinge approach, mainly in terms of less muscle damage and less perceived pain postoperatively. More research is required in order to further elucidate its efficacy.

Project description:BackgroundUnknown is which response rate on patient-reported outcome measures (PROMs) is needed to both obtain an accurate outcome and ensure generalizability in evaluating total hip arthroplasty (THA) procedures. Without an evidence based minimum response rate (MRR) on THA PROMs, it is possible that hospitals report invalid patient-reported outcomes (PROs) due to a too low response rate. Alternatively, hospitals may invest too much in achieving an unnecessary high response rate. The aim of this study is to gain an insight into the MRR on PROMs needed to adequately evaluate THA procedures from a clinical perspective.MethodsRetrospective study on prospective collected data of primary, elective THA procedures was performed. MRR was investigated for each PROM (NRS pain at rest, NRS pain during activity, EQ-5D-3L, HOOS-PS, anchor function, OHS, anchor pain and NRS satisfaction) separately to calculate the primary outcome: MRR for the THA PROMs set. MRR on a PROM needed to have (condition 1.) similar PRO change score (3 month score minus preoperative score) including confidence interval, (condition 2.) maintaining the influence of each change score predictor and (condition 3.) equal distribution of each predictor, as those of a 100% PROM response rate group. Per PROM, a 100%-group was identified with all patients having the PRO change score. Randomly assessed groups of 90% till 10% response rate (in total 90 groups) were compared with the 100%-group. Linear mixed model analyses and linear regressions were executed.ResultsThe MRR for the THA PROMs set was 100% (range: 70-100% per PROM). The first condition resulted in a MRR of 60%, the second condition in a MRR of 100% and the third condition in a MRR of 10%.ConclusionsA 100% response rate on PROMs is needed in order to adequately evaluate THA procedures from a clinical perspective. All stakeholders using THA PROs should be aware that 100% of the THA patients should respond on both preoperative and 3 month postoperative PROMs. For now, taking the first step in improving evaluation of THA for quality control by achieving at least two of the three conditions of MRR, advised is to require a response rate on PROMs of 60% as the lower limit.

Dataset Information

The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol.

Publications

The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol.

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