scholarly journals Does Oral Implant Design Affect Marginal Bone Loss? Results of a Parallel-Group Randomized Controlled Equivalence Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-11 ◽  
Author(s):  
Benedikt C. Spies ◽  
Maria Bateli ◽  
Ghada Ben Rahal ◽  
Marin Christmann ◽  
Kirstin Vach ◽  
...  
Keyword(s):  
Test Group ◽  
Primary Stability ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Implant Design ◽  
Control Group ◽  
Missed Appointments ◽  
Marginal Bone Loss ◽  
Patient Reported ◽  
One Year

Objective. To test whether or not the modified design of the test implant (intended to increase primary stability) has an equivalent effect on MBL compared to the control. Methods. Forty patients were randomly assigned to receive test or control implants to be installed in identically dimensioned bony beds. Implants were radiographically monitored at installation, at prosthetic delivery, and after one year. Treatments were considered equivalent if the 90% confidence interval (CI) for the mean difference (MD) in MBL was in between −0.25 and 0.25 mm. Additionally, several soft tissue parameters and patient-reported outcome measures (PROMs) were evaluated. Linear mixed models were fitted for each patient to assess time effects on response variables. Results. Thirty-three patients (21 males, 12 females; 58.2±15.2 years old) with 81 implants (47 test, 34 control) were available for analysis after a mean observation period of 13.9±4.5 months (3 dropouts, 3 missed appointments, and 1 missing file). The adjusted MD in MBL after one year was −0.13 mm (90% CI: −0.46–0.19; test group: −0.49; control group: −0.36; p=0.507). Conclusion. Both implant systems can be considered successful after one year of observation. Concerning MBL in the presented setup, equivalence of the treatments cannot be concluded. Registration. This trial is registered with the German Clinical Trials Register (ID: DRKS00007877).

scholarly journals Immediate Loading of Implant-Supported Single Crowns after Conventional and Ultrasonic Implant Site Preparation: A Multicenter Randomized Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Claudio Stacchi ◽  
Teresa Lombardi ◽  
Domenico Baldi ◽  
Calogero Bugea ◽  
Antonio Rapani ◽  
...  
Keyword(s):  
Survival Rate ◽  
Test Group ◽  
Site Preparation ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Marginal Bone Loss ◽  
One Year ◽  
And Control ◽  
Implant Site Preparation ◽  
Single Crowns

Aim. To compare implant survival rate and marginal bone loss (MBL) of immediately loaded single implants inserted by using ultrasonic implant site preparation (UISP) (test) and conventional rotary instrumentation (control). Methods. Two single implants were inserted for each patient: after randomization, test site was prepared by using an ultrasonic device (Piezosurgery Touch, Mectron, Italy) and control site was prepared by using the drills of the selected implant system (Premium AZT, Sweden & Martina, Italy), until reaching a final diameter of 3 mm in both groups. Identical implants (3.8x11.5 mm) were inserted in all sites at crestal level. Impressions were taken and screwed resin single crowns with platform-switched provisional abutments were delivered with 48 hours. Periapical radiographs were taken at provisional crown insertion (T0), 6 months (T1) and one year (T2) after prosthetic loading to measure MBL. All data were tested for normality and subsequently analyzed by paired samples t-test and forward multiple linear regression. Results. Forty-eight patients were treated in six centers with the insertion of ninety-six implants (48 test; 48 control). Four implants in four patients failed within the first six months of healing (two in test group; two in control group; no difference between groups). Forty patients (age 60.1±10.7 years; 22 female, 18 male) were included in the final analysis. Mean MBL after six months of loading was 1.39±1.03 mm in the test group and 1.42±1.16 mm in the control group (p>0.05) and after one year was 1.92±1.14 mm and 2.14±1.55 mm in test and control, respectively (p>0.05). Conclusions. No differences in survival rate and MBL were demonstrated between UISP and conventional site preparation with rotary instruments in immediately loaded dental implants: UISP, with its characteristics of enhanced surgical control and safety in proximity of delicate structures, may be used as a reliable alternative to the traditional drilling systems.

scholarly journals Diabetes is not associated with greater pain and worse patient-reported outcome measures one year after laminoplasty for cervical spondylotic myelopathy

2021 ◽  
Author(s):  
Kosei Nagata ◽  
Junya Miyahara ◽  
Hideki Nakamoto ◽  
Naohiro Kawamura ◽  
Yujiro Takeshita ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Cervical Spondylotic Myelopathy ◽  
Rating Scale ◽  
Short Form ◽  
Neck Disability Index ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Diabetic Group ◽  
Patient Reported ◽  
One Year

Abstract Although patients with diabetes reportedly have more peripheral neuropathy, the impacts of diabetes on postoperative recovery in pain and patient-reported outcome measures (PROMs) after laminoplasty for cervical spondylotic myelopathy (CSM) is not well characterized. The authors aimed to elucidate the effects of diabetes on neck/arm/hand/leg/foot pain and PROMs after laminoplasty CSM. The authors retrospectively reviewed 339 patients (82 with diabetes and 257 without) who underwent laminoplasty between C3 and C7 in 11 hospitals during April 2017−October 2019. Preoperative Numerical Rating Scale (NRS) scores in all five areas, the Short Form-12 Mental Component Summary, Euro quality of life 5-dimension, Neck Disability Index, and the Core Outcome Measures Index-Neck) were comparable between the groups. The between-group differences were also not significant in NRS scores and PROMs one after surgery. The change score of NRS hand pain was larger in the diabetic group than the nondiabetic group. The diabetic group showed worse preoperative score but greater improvement in the Short Form-12 Physical Component Summary than the nondiabetic group, following comparable score one year after surgery. These data indicated that the preoperative presence of diabetes, at least, did not adversely affect pain or PROMs one year after laminoplasty for CSM.

scholarly journals Orthopaedic registries with patient-reported outcome measures

2019 ◽  
Vol 4 (6) ◽  
pp. 357-367 ◽  
Author(s):  
Ian Wilson ◽  
Eric Bohm ◽  
Anne Lübbeke ◽  
Stephen Lyman ◽  
Søren Overgaard ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Medical Professional ◽  
Patient Reported ◽  
Measuring Outcomes ◽  
Total Knee ◽  
One Year ◽  
Value Based Care

Total joint arthroplasty is performed to decreased pain, restore function and productivity and improve quality of life. One-year implant survivorship following surgery is nearly 100%; however, self-reported satisfaction is 80% after total knee arthroplasty and 90% after total hip arthroplasty. Patient-reported outcomes (PROs) are produced by patients reporting on their own health status directly without interpretation from a surgeon or other medical professional; a PRO measure (PROM) is a tool, often a questionnaire, that measures different aspects of patient-related outcomes. Generic PROs are related to a patient’s general health and quality of life, whereas a specific PRO is focused on a particular disease, symptom or anatomical region. While revision surgery is the traditional endpoint of registries, it is blunt and likely insufficient as a measure of success; PROMs address this shortcoming by expanding beyond survival and measuring outcomes that are relevant to patients – relief of pain, restoration of function and improvement in quality of life. PROMs are increasing in use in many national and regional orthopaedic arthroplasty registries. PROMs data can provide important information on value-based care, support quality assurance and improvement initiatives, help refine surgical indications and may improve shared decision-making and surgical timing. There are several practical considerations that need to be considered when implementing PROMs collection, as the undertaking itself may be expensive, a burden to the patient, as well as being time and labour intensive. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180080

Treatment with and without stabilizing lumbar spinal orthosis after one- or two-level spondylodesis: A randomized controlled trial

2020 ◽  
Vol 28 (5) ◽  
pp. 541-549
Author(s):  
Yorck Rommelspacher ◽  
Hannah Bode ◽  
Jana Ziob ◽  
Charlotte Struwe ◽  
Adnan Kasapovic ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Control Group ◽  
Patient Reported ◽  
Subjective Pain ◽  
Postoperative Mobility ◽  
Lumbar Spinal ◽  
Spinal Orthosis

BACKGROUND AND OBJECTIVE: Musculature affected during spondylodesis surgery may benefit and recover faster if supported by spine orthosis postoperatively. METHODS: This prospective study included 50 consecutive patients undergoing one- or two-level spondylodesis. The intervention group received a lumbar spine orthosis (n= 23), while the control group remained without orthosis (n= 27). Patients were assessed for pain (Visual Analogue Scale, VAS), Oswestry Disability index (ODI) as well as the use of analgesics. RESULTS: Patients wearing an orthosis postoperatively reported a higher degree of subjective stability. However, both intervention as well as control group did not show any significant differences for each of the follow-up points regarding VAS, ODI or the use of analgesics. CONCLUSION: Wearing an orthosis has neither impact on subjective pain, the need for analgesics nor for postoperative functionality. However, patients reported that they profited from wearing the orthosis by feeling more stable, thereby nicely improving their postoperative mobility. Thus, novel patient reported outcome measures have to be developed to assess these features in future studies.

Quality Assurance in Cataract and Lens Surgery with Special Consideration of Subjective Patient Reported Outcome Measures and Clinical Reported Outcome Measures

2021 ◽  
Author(s):  
Ekkehard Fabian ◽  
Max Birkl ◽  
Franz Benstetter ◽  
Philipp Eberwein ◽  
Ulrich Seher ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Outcome Measure ◽  
Data Transfer ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
High Rate ◽  
Automatic Data ◽  
Medical Interventions ◽  
Patient Reported ◽  
One Year

Abstract Background Results of medical interventions must be documented and evaluated. In studies, this is done with clinical outcomes data (clinician/clinical reported outcome measure, CROM). In the past, less weight has been given to patient surveys with questionnaires (patient reported outcome measure, PROM). Patients/Materials and Methods This retrospective study included 104 eyes from 53 patients. Of these, 35 patients had cataract surgery and 15 patients had a refractive lens exchange. The implanted lenses included 62 trifocal IOLs (Asphina trifiocal 839, Zeiss), 34 trifocal toric IOLs (Asphina trifocal toric 939, Zeiss) and 8 bifocal IOLs (Asphina 808, Zeiss) with the same IOL platform. Patients completed a modified questionnaire before surgery and one year after surgery. We made changes to the CatQuest-9SF questionnaire so as to also document side effects. Results The effort required by the patients to answer the questionnaire was a burden. Transcribing the data into electronic files so as they could be saved and analyzed was a lot of work for the staff. Among the patients, 88.7% were spectacle-independent in everyday life, and 77.5% for reading. 44.4% had a halo problem. 92% reported the operation as a success. 100% had a prediction error of ≤ ± 0.75 dpt. Conclusion There is a high rate of patient satisfaction with the outcome of the intervention. New questionnaires are needed for new IOLs. The Catquest-9SF is from 2009. Accordingly, revisions and new validation is necessary. Beyond that, only automatic data transfer will reduce the amount of work involved in data input.

Identification of Factors Predictive for Patient Reported Outcomes in the Prospective Australian Breast Device Registry

2021 ◽  
Author(s):  
Jessy Hansen ◽  
Susannah Ahern ◽  
Pragya Gartoulla ◽  
Ying Khu ◽  
Elisabeth Elder ◽  
...  
Keyword(s):  
Risk Adjustment ◽  
Breast Implants ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Logistic Regression Models ◽  
Multivariate Risk ◽  
Patient Reported ◽  
The Aesthetic ◽  
One Year

Abstract Background Patient-reported outcome measures (PROMs) are an important tool for evaluating outcomes following breast device procedures, and are used by breast device registries. PROMs can assist with device monitoring through benchmarked outcomes, but need to account for demographic and clinical factors which may affect PROMs responses. Objectives This study aimed to develop appropriate risk-adjustment models for the benchmarking of PROMs data to accurately track device outcomes and identify outliers in an equitable manner. Methods Data for this study were obtained from the Australian Breast Device Registry, which consists of a large prospective cohort of patients with primary breast implants. The five-question BREAST-Q implant surveillance module was used to assess PROMs at one-year following implant insertion. Logistic regression models were used to evaluate associations between demographic and clinical characteristics and PROMs separately by implant indication. Final multivariate risk-adjustment models were built sequentially assessing the independent significant association of these variables. Results 2,221 reconstructive and 12,045 aesthetic primary breast implants with complete one-year follow-up PROMs were included in the study. Indication for operation (post-cancer, risk-reduction, developmental deformity) was included in the final model for all reconstructive implant PROMs. Site type (private or public hospital) was included in the final breast reconstruction model for look, rippling and tightness. Age at operation was included in the reconstruction models for rippling and tightness and in the aesthetic models for look, rippling, pain and tightness. Conclusions These multivariate models will be useful for equitable benchmarking of breast devices by PROMs to help track device performance.

Interpretation of patient-reported outcome measures for varicose vein surgery

2011 ◽  
Vol 27 (4) ◽  
pp. 173-178 ◽  
Author(s):  
C Nesbitt ◽  
W R W Wilson ◽  
T A Lees ◽  
G Stansby
Keyword(s):  
Outcome Measures ◽  
Varicose Vein ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Varicose Vein Surgery ◽  
Patient Reported ◽  
Potential Impact ◽  
One Year ◽  
The One ◽  
Preoperative Score

Objectives Since 2009 the National Health Service (NHS) has been collecting patient-reported outcome measures (PROMs) following varicose vein interventions. The objective of this manuscript was to interrogate the one-year PROMs data with respect to varicose vein intervention and to discuss its potential impact on the provision of service. Methods We interrogated the one-year PROMs data with respect to potential impact on the provision of service. Results In total, 37,521 varicose vein operations were performed during the study period (1 April 2009–30 April 2010). A total of 15,808 preoperative questionnaires were completed and returned and 12,509 were linked to Hospital Episode Statistics episodes. A total of 8127 postoperative questionnaires were completed and linked to the preoperative questionnaires. For the EuroQuol (EQ) 5D questionnaire average preoperative score across the completed data-set was 0.773. The postoperative health gain was 0.094. Fifty-three percent of patients had improved postoperative scores, 33% reported no change, while 14% reported a reduction in their postoperative EQ-5D score. Pain/discomfort was the only domain where patients reported any negative symptoms; 72% (5390) reported pain/discomfort preoperatively and 37% (2804) postoperatively. In total, 62.6% (4685) reported no pain/discomfort following surgery A total of 7167 complete, linked and eligible data-sets were observed for the Aberdeen Varicose Vein Questionnaire (AVVQ). The average preoperative score was 18.75. The average postoperative score was 10.76. This represented a reduction in symptom scores of one-half following intervention. The lowest improvements were witnessed in patients with the lowest preoperative scores (least severe symptoms). Additional postoperative questions highlighted the improvements conferred from varicose vein surgery with 90.3% of patients reporting an improvement in their problems from varicose veins following surgery and 85% describing their operative results as excellent, very good or good. Conclusion These data have shown variable improvements following venous interventions. PROMs are likely to have significant implications for health care in the NHS on a number of levels including provision of funding and future planning of services.

Longitudinal changes in patient-reported outcome measures following total hip arthroplasty and predictors of deterioration during follow-up

2019 ◽  
Vol 101-B (7) ◽  
pp. 768-778 ◽  
Author(s):  
V. P. Galea ◽  
P. Rojanasopondist ◽  
L. H. Ingelsrud ◽  
H. E. Rubash ◽  
C. Bragdon ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Significant Deterioration ◽  
Sf 36 ◽  
Patient Reported ◽  
Clinically Significant ◽  
One Year ◽  
Anxiety Depression

AimsThe primary aim of this study was to quantify the improvement in patient-reported outcome measures (PROMs) following total hip arthroplasty (THA), as well as the extent of any deterioration through the seven-year follow-up. The secondary aim was to identify predictors of PROM improvement and deterioration.Patients and MethodsA total of 976 patients were enrolled into a prospective, international, multicentre study. Patients completed a battery of PROMs prior to THA, at three months post-THA, and at one, three, five, and seven-years post-THA. The Harris Hip Score (HHS), the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS), the SF-36 Mental Component Summary (MCS), and the EuroQol five-dimension three-level (EQ-5D) index were the primary outcomes. Longitudinal changes in each PROM were investigated by piece-wise linear mixed effects models. Clinically significant deterioration was defined for each patient as a decrease of one half of a standard deviation (group baseline).ResultsImprovements were noted in each PROM between the preoperative and one-year visits, with one-year values exceeding age-matched population norms. Patients with difficulty in self-care experienced less improvement in HHS (odds ratio (OR) 2.2; p = 0.003). Those with anxiety/depression experienced less improvement in PCS (OR -3.3; p = 0.002) and EQ-5D (OR -0.07; p = 0.005). Between one and seven years, obesity was associated with deterioration in HHS (1.5 points/year; p = 0.006), PCS (0.8 points/year; p < 0.001), and EQ-5D (0.02 points/year; p < 0.001). Preoperative difficulty in self-care was associated with deterioration in HHS (2.2 points/year; p < 0.001). Preoperative pain from other joints was associated with deterioration in MCS (0.8 points/year; p < 0.001). All aforementioned factors were associated with clinically significant deterioration in PROMs (p < 0.035), except anxiety/depression with regard to PCS (p = 0.060).ConclusionThe present study finds that patient factors affect the improvement and deterioration in PROMs over the medium term following THA. Special attention should be given to patients with risk factors for decreased PROMs, both preoperatively and during follow-up. Cite this article: Bone Joint J 2019;101-B:768–778.

Postoperative stiffness after reverse total shoulder arthroplasty

2020 ◽  
pp. 175857322096731
Author(s):  
Mohammad Ghoraishian ◽  
Brian W Hill ◽  
Thema Nicholson ◽  
Matthew L Ramsey ◽  
Gerald R Williams ◽  
...  
Keyword(s):  
Range Of Motion ◽  
Shoulder Arthroplasty ◽  
Reverse Shoulder Arthroplasty ◽  
Total Shoulder Arthroplasty ◽  
Patient Reported Outcome ◽  
Implant Design ◽  
Consecutive Series ◽  
Patient Reported ◽  
Outcome Scores ◽  
One Year

Purpose The purpose of this study was to evaluate the rate and risk factors for stiffness after reverse shoulder arthroplasty and the ramifications on the patient-reported outcomes. Method A consecutive series of patients who underwent reverse shoulder arthroplasty were prospectively followed for one year. Passive range of motion was measured preoperatively and at regular intervals postoperatively. Patients with passive forward elevation of less than 100° or passive external rotation of less than 30° were defined as stiff. Radiographic parameters and postoperative patient-reported outcome scores were collected. Results Seventy-six patients were available for review. The prevalence of postoperative stiffness following reverse shoulder arthroplasty was 47% at three months, 31% at six months, and 25% at one year. Preoperative shoulder stiffness was associated with three-month postoperative stiffness only. In patients with one-year stiffness, smaller ( p = 0.03) and less lateralized glenospheres ( p = 0.024) were more common. Stiffness was not associated with one-year patient-reported outcome scores. Conclusion Stiffness is common after reverse shoulder arthroplasty and often improves at one-year after surgery. Implant design and selection may be important determinants of passive range of motion. While stiffness does not appear to influence patient-reported outcome scores, one of four patients will potentially have stiffness one year following reverse shoulder arthroplasty. Level of evidence: Level III; retrospective study.

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