The influence of hydroxyapatite coating on continuous migration of a Zweymuller-type hip stem: a double-blinded randomised RSA trial with 5-year follow-up

2021 ◽  
pp. 112070002110067
Author(s):  
Daniel Hoornenborg ◽  
Annelieke M C Schweden ◽  
Inger N Sierevelt ◽  
Harm M van der Vis ◽  
GMMJ Kerkhoffs ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Hydroxyapatite Coating ◽  
Time Interval ◽  
Post Surgery ◽  
Initial Surgery ◽  
Long Term Effect ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Double Blinded

Background and purpose: Adding hydroxyapatite to a stem to enhance ingrowth is a matter of debate, even less is known about the long-term effect on stability by adding hydroxyapatite (HA). Continuous migration in the first 2–5 years is an indicator of failed osteointegration or pending failure, enhancing the risk of loosening within 10 years after initial surgery. We performed a double-blinded randomised RSA trial with 5-year follow-up, to compare and analyse migration characteristics of the hydroxyapatite uncoated (HA−) and hydroxyapatite coated (HA+) Zweymuller-type hip stem. Patients and methods: In this single-centre prospective randomised controlled trial 51 patients were randomised to receive either a HA− or a HA+ Zweymuller-type hip stem during total hip replacement. After 5 years, 35 patients were still eligible for follow-up evaluation. The migration pattern was measured by use of radio stereometric analysis (RSA) images up to 2 years to evaluate short-term migration, additionally RSA images were obtained 5 years postoperatively to assess late-term and continuous migration. Furthermore, the improvement of clinical outcome was analysed by HSS and HOOS ADL and pain subscales preoperative and after 5 years. Results: After initial settling of the implant, no significant migration occurred up to 5 years post-surgery for HA+ as well as HA− prostheses. Continuous migration within the 2–5 years’ time interval was not observed for both HA+ nor the HA− group in all directions ( p < 0.05). No significant difference between both groups was observed ( p < 0.10). In both groups the HHS and HOOS improved significantly at 5 years compared to baseline for both groups. Improvement was not altered by the hydroxyapatite coating. No significant difference between both groups was observed ( p > 0.58). Conclusions: Addition of a hydroxyapatite coating did not influence the migration 5 years postoperatively for the Zweymuller-type hip stem. Clinical Trial Protocol number: NL 23524.048.08

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

scholarly journals Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0241704
Author(s):  
Jennifer Wild ◽  
Shama El-Salahi ◽  
Michelle Degli Esposti ◽  
Graham R. Thew
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Self Report ◽  
Post Traumatic Stress ◽  
Emergency Responders ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

Does hydroxyapatite coating enhance ingrowth and improve longevity of a Zweymuller type stem? A double-blinded randomised RSA trial

2017 ◽  
Vol 28 (2) ◽  
pp. 115-121 ◽  
Author(s):  
Daniel Hoornenborg ◽  
Inger N. Sierevelt ◽  
Joost A. Spuijbroek ◽  
John Cheung ◽  
Harm M. van der Vis ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Femoral Stem ◽  
Hydroxyapatite Coating ◽  
Harris Hip Score ◽  
Double Blind ◽  
Long Term Outcome ◽  
Total Hip ◽  
Early Migration ◽  
Significant Difference

Introduction: An ongoing discussion is whether using a hydroxyapatite coating enhances the ingrowth and longevity of a femoral stem in total hip arthroplasty. The best way to predict speed of ingrowth and long-term outcome is by evaluating micromotion by radiostereometric analysis. To study the effect of hydroxyapatite (HA) coating on the migration of the SL-PLUS hip stem, we performed a prospective double blind randomised controlled trial comparing the early migration of the hydroxyapatite (HA)-coated SL-PLUS stem compared to the Standard (non-coated) SL-PLUS stem. Patients and methods: 51 patients were randomly assigned to receive either an uncoated or a HA-coated femoral component during total hip replacement. RSA images were obtained direct postoperatively and at 6 weeks, 12 weeks, 6 months, 12 months and 24 months. HOOS scores were obtained preoperative and at final follow-up. Results: RSA evaluation demonstrated significant migration up to 3 months postoperatively in both groups. After initial setting no significant migration was observed. There was no significant difference in migration between the HA-coated group and the uncoated group. Both Harris Hip Score (HHS) and HOOS domain scores (pain and ADL) significantly improved compared to baseline at 24 months after surgery in both treatment groups (p<0.001 for all comparisons). Improvement did not differ significantly between the 2 groups. Conclusions: At 2 years follow-up, the HA-coated and uncoated Zweymuller type, distal fitting stem do not show different migration patterns.

scholarly journals Digital Smile Designed Computer-Aided Surgery versus Traditional Workflow in “All on Four” Rehabilitations: A Randomized Clinical Trial with 4-Years Follow-Up

2021 ◽  
Vol 18 (7) ◽  
pp. 3449
Author(s):  
Francesca Cattoni ◽  
Luca Chirico ◽  
Alberto Merlone ◽  
Michele Manacorda ◽  
Raffaele Vinci ◽  
...  
Keyword(s):  
Bone Loss ◽  
Computer Aided Design ◽  
Immediate Loading ◽  
Time Interval ◽  
Marginal Bone Loss ◽  
Traditional Group ◽  
Post Surgery ◽  
Significant Difference ◽  
Computer Aided

The aim of the present study was to evaluate and compare the traditional “All on Four” technique with digital smile designed computer-aided “All on Four” rehabilitation; with a 4-years follow-up. The protocol was applied to a total of 50 patients randomly recruited and divided in two groups. Digital protocol allows for a completely virtual planning of the exact position of the fixtures, which allows one to perform a flapless surgery procedure with great accuracy (mini-invasive surgery) and also it is possible to use virtually planned prostheses realized with Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) (methods for an immediate loading of the implants. After 4 years from the treatments 98% of success were obtained for the group of patients treated with the traditional protocol and 100% for the digital protocol. At each time interval a significant difference in peri-implant crestal bone loss between the two groups was detected; with an average Marginal Bone Loss (MBL) at 4 years of 1.12 ± 0.26 mm in the traditional group and 0.83 ± 0.11 mm in the digital group. Patients belonging to the digital group have judged the immediate loading (92%), digital smile preview (93%), the mock-up test (98%) and guided surgery (94%) as very effective. All patients treated with a digital method reported lower values of during-surgery and post-surgery pain compared to patients rehabilitated using traditional treatment. In conclusion, the totally digital protocol described in the present study represents a valid therapeutic alternative to the traditional “All on Four” protocol for implant-supported rehabilitations of edentulous dental arches.

Comparison of the efficacy of Acupuncture and Conventional Physiotherapy treatment in the management of SIJ dysfunction- A Randomised controlled trial (RCT)

2016 ◽  
Author(s):  
Ganiyu Oluwaleke Sokunbi ◽  
Fatima Gujba Kachalla
Keyword(s):  
Pain Intensity ◽  
Functional Disability ◽  
Controlled Trial ◽  
Control Group ◽  
Invasive Treatment ◽  
Pain Scores ◽  
Significant Difference ◽  
Conventional Physiotherapy ◽  
Randomised Controlled

Background: The question of what form of non-invasive treatment is most effective for sacroiliac joint (SIJ) dysfunction has not been sufficiently addressed. The quality of evidence regarding the efficacy of a conservative treatment approach is low, and there is no evidence for sustained benefits.Objectives: To compare the efficacy of acupuncture and conventional physiotherapy in the management of pain and functional disability in patients with SIJ dysfunction.Methods: Forty women with SIJ dysfunction with a mean age of 29.3± 4.3 years participated in the study. Ten participants were randomised into each of three intervention groups (acupuncture (ACT); conventional physiotherapy (CPT); and acupuncture combined with conventional physiotherapy (ACPT)) and a control group (CG) (education and advice). Treatment interventions were provided three times a week for five weeks. The main outcome measures were pain intensity measured with visual analogue scale (VAS) and functional disability measured with Roland Morris Disability Questionnaire (RMDQ). Assessments were carried out by an independent examiner before and after the intervention and at 3 months follow-up.Results: Baseline VAS and RMDQ scores did not show significant differences among the groups. After treatment, the participants in all the intervention groups had reduced pain scores on the VAS scale (ACT= 3.5±0.06, CPT =3.0±0.08 and ACPT=1.2±0.98) and improved function on RMDQ scores (ACT =7.0±1.53, CPT = 6.0±.01, ACPT = 3.0± 0.08) compared to those in the control group, who recorded 7.4±0.08 and 17.5± 4.32 for pain intensity and functional disability, respectively. However, pain reduction and improvement in function was greatest in the ACPT at the end of the 5-week treatment and at 3-month follow-up (VAS=1.0±0.04, RMDQ =2.0± 0.07) compared with the other intervention groups (VAS: ACT= 4.0±0.97, CPT = 3.5±1.00 and RMDQ: ACT=7.0±1.6, CPT=5.0±0.87). There was a significant difference in the pain scores on VAS (F =67.171, P=0.000) and functional disability on RMDQ scores (F=62.467, P=0.000) among the groups after 5 weeks of treatment and at 3-month post-treatment follow-up assessment VAS (F =79.903, P=0.000) and RMDQ (F =75.301, P=0.000), which was not present at the baseline.Conclusion: Findings from this study showed that acupuncture or conventional physiotherapy alone or in combination is more effective than advice and education. The combination of acupuncture and conventional therapy is more effective than both treatments alone.

scholarly journals Does addition of craving management tools in a stop smoking app improve quit rates among adult smokers? Results from BupaQuit pragmatic pilot randomised controlled trial.

2019 ◽  
Author(s):  
Aleksandra Herbec ◽  
Lion Shahab ◽  
Jamie Brown ◽  
Harveen Kaur Ubhi ◽  
Emma Beard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Point Prevalence ◽  
Management Tools ◽  
Exact Test ◽  
Significant Difference ◽  
Continuous Abstinence ◽  
Randomised Controlled

Introduction: Delivery of craving management tools (CMTs) via smartphone applications (apps) may improve smoking cessation rates, but research on such programmes remainslimited, especially in real-world settings. This study evaluated the effectiveness of adding CMTs in a cessation app (BupaQuit).Methods: The study was a two-arm pragmatic pilot parallel randomised controlled trial, comparing a fully-automated BupaQuit app with CMT with a control app version withoutCMT. A total of 425 adult UK-based daily smokers were enrolled through open online recruitment (February 2015-March 2016), with no researcher involvement, and individually randomised within the app to the intervention (n=208) or control (n=217). The primary outcome was self-reported 14-day continuous abstinence assessed at 4-week follow-up. Secondary outcomes included 6-month point-prevalence and sustained abstinence, and app usage. The primary outcome was assessed with Fisher’s exact test using intent to treat with those lost to follow-up counted as smoking. Participants were not reimbursed.Results: Re-contact rates were 50.4% at 4 weeks and 40.2% at 6 months. There was no significant difference between intervention and control arms on the primary outcome (13.5% vs 15.7%; p=0.58;RR=0.86, 95% Confidence Interval (CI)=0.54-1.36) or secondary cessation outcomes (6-month point prevalence: 14.4% vs. 17.1%, p=0.51;RR=0.85, 95%CI=0.54-1.32; 6-month sustained: 11.1% vs 13.4%, p=0.55,RR=0.83,95%CI=0.50-1.38). Bayes factors supported the null hypothesis (B[0, 0,1.0986]=.20). Usage was similar across the conditions (mean/median logins: 9.6/4 vs. 10.5/5; time spent: 401.8/202s vs. 325.8/209s).Conclusions: The addition of craving management tools did not affect cessation, and the limited engagement with the app may have contributed to this.

scholarly journals Effect of a structured educational intervention on explanatory models of relatives of patients with schizophrenia

2006 ◽  
Vol 188 (3) ◽  
pp. 286-287 ◽  
Author(s):  
S. Das ◽  
B. Saravanan ◽  
K. P. Karunakaran ◽  
S. Manoranjitham ◽  
P. Ezhilarasu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Educational Programme ◽  
Explanatory Models ◽  
Control Group ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Biomedical Treatment ◽  
Trial Participants

SummaryWe examined the effect of a structured educational programme on explanatory models of illness among the relatives of people with schizophrenia, in a randomised controlled trial. Participants were assessed at baseline (n=100) and after 2 weeks (n=75) using a vignette from the Short Explanatory Model Interview. There was a reduction in non-biomedical causal explanatory models at follow-up among those who had completed the structured educational programme compared with the control group. There was no significant difference in non-biomedical treatment explanatory models between the two groups.

scholarly journals Long-term effect of physical activity on health-related quality of life among menopausal women: a 4-year follow-up study to a randomised controlled trial

BMJ Open ◽  
2015 ◽  
Vol 5 (9) ◽  
pp. e008232 ◽  
Author(s):  
Kirsi Mansikkamäki ◽  
Jani Raitanen ◽  
Clas-Håkan Nygård ◽  
Eija Tomás ◽  
Reetta Rutanen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Follow Up Study ◽  
Long Term Effect ◽  
Menopausal Women ◽  
Related Quality ◽  
Health Related ◽  
Randomised Controlled

Effect of Different Liners on Pulpal Outcome after Partial Caries Removal: A Preliminary 12 Months Randomised Controlled Trial

2019 ◽  
Vol 53 (5) ◽  
pp. 547-554 ◽  
Author(s):  
Shreya Singh ◽  
Shweta Mittal ◽  
Sanjay Tewari
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Permanent Teeth ◽  
Categorical Variables ◽  
Significant Difference ◽  
Caries Removal ◽  
Randomised Controlled ◽  
Analytical Approaches ◽  
Partial Caries Removal

Aim: The aim of this double-blinded parallel randomised controlled trial was to compare the effect of different liners on 12-month pulp health outcomes after partial caries removal (PCR) with composite restorations in permanent molars. Methods: The study was registered at clinicaltrials.gov with registration No. NCT0328695 and conducted in the Department of Conservative dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak with no external financial support. One hundred and ninety-eight participants (116 males, 82 females and age 14–54 years) with vital permanent mature mandibular molars having deep caries involving two-thirds or more of dentin were randomised to calcium hydroxide (CH), resin-modified GIC (RMGIC) and no liner (DC) groups after PCR. After a follow-up time of 12 months, success was defined as positive response to pulp sensibility and absence of periapical alterations. Results: Categorical variables were compared using chi-square test. Two analytical approaches were used, such as intention-to-treat and per-protocol approach. Success rates in per-protocol approach were 96.8, 96.5, and 94.6% for CH, RMGIC and DC groups, respectively with no significant difference between 3 groups (p = 0.811). None of the baseline variables had any significant influence on the treatment success. Conclusion: Partial caries excavation has a high success rate to treat deep carious lesions in permanent teeth after 12 months of follow-up, indicating that the retention of carious dentin does not interfere with pulp vitality or restoration survival. Also, the success of the treatment is independent of the lining material used over the demineralized dentin.

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