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result(s) for
"Knee replacement"
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Does Tourniquet Use in TKA Affect Recovery of Lower Extremity Strength and Function? A Randomized Trial
by
Kittelson, Andrew J.
,
Yang, Charlie C.
,
Stevens-Lapsley, Jennifer E.
in
Aged
,
Arthroplasty, Replacement, Knee - adverse effects
,
Arthroplasty, Replacement, Knee - instrumentation
2016
Background
Tourniquet use during total knee arthroplasty (TKA) improves visibility and reduces intraoperative blood loss. However, tourniquet use may also have a negative impact on early recovery of muscle strength and lower extremity function after TKA.
Questions/purposes
The purpose of this study was (1) to determine whether tourniquet use affects recovery of quadriceps strength (primary outcome) during the first 3 postoperative months; and (2) to examine the effects of tourniquet application on secondary outcomes: voluntary quadriceps activation, hamstring strength, unilateral limb balance as well as the effect on operative time and blood loss.
Methods
Twenty-eight patients (mean age 62 ± 6 years; 16 men) undergoing same-day bilateral TKA (56 lower extremities) were enrolled in a prospective, randomized study. Subjects were randomized to receive a tourniquet-assisted knee arthroplasty on one lower extremity while the contralateral limb underwent knee arthroplasty without extended tourniquet use. In the former group, the tourniquet was inflated just before the incision was made and released after cementation; in the latter group, a tourniquet was not used (10 of 28 [36%]) or inflated only during component cementation (18 of 28 [64%]). The choice of no tourniquet or use just during cementation was based on surgeon choice, because some surgeons felt a tourniquet during cementation was necessary to achieve a dry surgical field to maximize cement fixation. A median parapatellar approach and the identical posterior-stabilized TKA design were used by all four fellowship-trained knee surgeons involved. Isometric quadriceps strength, hamstring strength, voluntary quadriceps activation, and unilateral balance were assessed preoperatively, 3 weeks, and 3 months after bilateral knee arthroplasty. Other factors, including pain, range of motion, and lower extremity girth, were assessed for descriptive purposes at each of these time points as well as on the second postoperative day.
Results
Quadriceps strength was slightly lower in the tourniquet group compared with the no-tourniquet group (group difference = 11.27 Nm [95% confidence interval {CI}, 2.33–20.20]; p = 0.01), and these differences persisted at 3 months after surgery (group difference = 9.48 Nm [95% CI, 0.43–18.54]; p = 0.03). Hamstring strength did not differ between groups at any time point nor did measures of quadriceps voluntary activation or measures of unilateral balance ability. There was less estimated intraoperative blood loss in the tourniquet group (84 ± 26 mL) than in the no-tourniquet group (156 ± 63 mL) (group difference = −74 mL [95% CI, −100 to −49]; p < 0.001). However, there was no difference in total blood loss between the groups (group difference = −136 mL [95% CI, −318 to 45]; p = 0.13).
Conclusions
Patients who underwent TKA using a tourniquet had diminished quadriceps strength during the first 3 months after TKA, the clinical significance of which is unclear. Future studies may be warranted to examine the effects of tourniquet use on long-term strength and functional outcomes.
Level of Evidence
Level I, therapeutic study.
Journal Article
Two-Year Evaluation of Mandatory Bundled Payments for Joint Replacement
by
Mehrotra, Ateev
,
McWilliams, J. Michael
,
Epstein, Arnold M
in
Aging
,
Arthroplasty, Replacement, Hip - adverse effects
,
Arthroplasty, Replacement, Hip - economics
2019
In 2016, Medicare started mandatory bundled payment for joint-replacement surgery in randomly selected areas. Hospitals receive bonuses or pay penalties based on spending through 90 days after discharge. In the first 2 years, there was a slight reduction in spending.
Journal Article
A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty
2020
Background
Total knee arthroplasty (TKA) with mechanical alignment (MA) aims to achieve neutral limb alignment in all patients, whereas TKA with functional alignment (FA) aims to restore native, patient-specific anatomy and knee kinematics by manipulating bone resections and fine-tuning implant positioning. The objective of this study is to determine the optimal alignment technique in TKA by comparing patient satisfaction, functional outcomes, implant survivorship, complications, and cost-effectiveness in MA TKA versus FA TKA. Robotic technology will be used to execute the planned implant positioning and limb alignment with high-levels of accuracy in all study patients.
Methods and analysis
This prospective double-blinded randomised control trial will include 100 patients with symptomatic knee osteoarthritis undergoing primary robotic arm-assisted TKA. Following informed consent, patients will be randomised to MA TKA (the control group) or FA TKA (the investigation group) at a ratio of 1:1 using an online random number generator. Blinded observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning and limb alignment, gait, implant stability, cost-effectiveness, and complications. A superiority study design will be used to evaluate whether FA TKA provides superior outcomes compared to MA TKA. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. The following statistical methods will be employed to analyse the data: descriptive statistics, independent
t
test, paired
t
test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Surrey Research Ethics Committee, UK. The study is sponsored by University College London, UK.
Discussion
This is the first study to describe the use of robotic technology to achieve FA TKA, and the only existing clinical trial comparing robotic MA TKA versus robotic FA TKA. The findings of this study will enable an improved understanding of the optimal alignment technique in TKA for achieving high-levels of patient satisfaction, improving functional outcomes, increasing implant survivorship, improving cost-effectiveness, and reducing complications.
Registration
Clinical
Trials.gov
,
NCT04092153
. Registered on 17 September 2019.
Journal Article
The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial
2019
Late-stage isolated medial knee osteoarthritis can be treated with total knee replacement (TKR) or partial knee replacement (PKR). There is high variation in treatment choice and little robust evidence to guide selection. The Total or Partial Knee Arthroplasty Trial (TOPKAT) therefore aims to assess the clinical effectiveness and cost-effectiveness of TKR versus PKR in patients with medial compartment osteoarthritis of the knee, and this represents an analysis of the main endpoints at 5 years.
Our multicentre, pragmatic randomised controlled trial was done at 27 UK sites. We used a combined expertise-based and equipoise-based approach, in which patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR were randomly assigned (1:1) to receive PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure. The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups. Health-care costs (in UK 2017 prices) and cost-effectiveness were also assessed. This trial is registered with ISRCTN (ISRCTN03013488) and ClinicalTrials.gov (NCT01352247).
Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45%) patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients were randomly assigned to groups. 94% of participants responded to the follow-up survey 5 years after their operation. At the 5-year follow-up, we found no difference in OKS between groups (mean difference 1·04, 95% CI −0·42 to 2·50; p=0·159). In our within-trial cost-effectiveness analysis, we found that PKR was more effective (0·240 additional quality-adjusted life-years, 95% CI 0·046 to 0·434) and less expensive (−£910, 95% CI −1503 to −317) than TKR during the 5 years of follow-up. This finding was a result of slightly better outcomes, lower costs of surgery, and lower follow-up health-care costs with PKR than TKR.
Both TKR and PKR are effective, offer similar clinical outcomes, and result in a similar incidence of re-operations and complications. Based on our clinical findings, and results regarding the lower costs and better cost-effectiveness with PKR during the 5-year study period, we suggest that PKR should be considered the first choice for patients with late-stage isolated medial compartment osteoarthritis.
National Institute for Health Research Health Technology Assessment Programme.
Journal Article
PSI kinematic versus non-PSI mechanical alignment in total knee arthroplasty: a prospective, randomized study
2017
Purpose
Kinematic alignment in TKA is supposed to restore function by aligning the components to the premorbid flexion–extension axis instead of altering the joint line and natural kinematic axes of the knee. The purpose of this study was to compare mechanically aligned TKA to kinematic alignment.
Methods
In this study, 200 patients underwent TKA and were randomly assigned to 2 groups: 100 TKAs were performed using kinematic alignment with custom-made cutting guides in order to complete cruciate-retaining TKA; the other 100 patients underwent TKA that was manually performed using mechanical alignment. The WOMAC and combined Knee Society Score (KSS), as well as radiological alignment, were determined as outcome parameters at the 12-month endpoint.
Results
WOMAC and KSS significantly improved in both groups. There was a significant difference in both scores between groups in favour of kinematic alignment. Although the kinematic alignment group demonstrated significantly better overall results, more outliers with poor outcomes were also seen in this group. A correlation between post-operative alignment deviation from the initial plan and poor outcomes was also noted. The most important finding of this study is that applying kinematic alignment in TKA achieves comparable results to mechanical alignment in TKA. This study also shows that restoring the premorbid flexion–extension axis of the knee joint leads to better overall functional results.
Conclusion
Kinematic alignment is a favourable technique for TKA.
Clinical relevance
The kinematic alignment idea might be a considerable alternative to mechanical alignment in the future.
Level of evidence
II.
Journal Article
Evaluating the clinical outcomes of computer-assisted surgery and patient-specific instrumentation compared to conventional instrumentation in total knee arthroplasty, a randomised controlled trial
by
Han, Zhencan
,
Tian, Hua
,
Feng, Junhao
in
3D printed implants in orthopedic surgery
,
Aged
,
Ankle
2025
Objective
Computer-assisted surgery (CAS) and patient-specific instrumentation (PSI) are digital techniques to improve the accuracy of implant positioning in total knee arthroplasty (TKA), but their effects on clinical outcomes are still in dispute. The objective of this trial is to evaluate the efficacy and safety of CAS and PSI compared to conventional instrumentation (CI) in TKA.
Methods
A prospective randomized controlled trial was conducted. A total of 135 patients undergoing TKA were randomized into CAS group, PSI group and CI group with 45 patients in each group. Primary outcome is the coronal mechanical axis of lower extremity. Secondary outcomes include Femoral Rotation Angle (FRA) of the femoral prosthesis, operation time, perioperative blood loss, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Forgotten Joint Score (FJS) and complications.
Results
Outliers of Hip-Knee-Ankle angle (HKA) were 24.4% in CI group, 17.8% in CAS group and 31.1% in PSI group respectively, and there was no significant difference among these 3 groups (
P
> 0.05). Outliers of FRA were 13.3% in CI group, 26.7% in CAS group and 11.1% in PSI group respectively with no significant difference (
P
> 0.05). Operation time was (66.67 ± 12.85)min, (81.67 ± 12.31)min and (52.78 ± 8.62)min in CI, CAS and PSI group. Operation time in CI was longer than PSI and shorter than CAS with significant difference (
P
< 0.01). There was no significant difference in comparison of blood loss, transfusion rate, postoperative WOMAC and FJS (
P
> 0.05).
Conclusion
CAS and PSI, compared with CI, did not significantly improve clinical outcomes including lower limb alignment, rotation of femoral prosthesis, blood loss, transfusion rate, and function scores. However, CAS was associated with prolonged operation time, whereas PSI resulted in a reduced operation time.
Level of evidence
Level II.
Trial registration
ChiCTR-INR-17,012,881 (registration date: 03/10/2017).
Journal Article
Small Improvements in Mechanical Axis Alignment Achieved With MRI versus CT-based Patient-specific Instruments in TKA: A Randomized Clinical Trial
by
von Roth, Philipp
,
Hommel, Hagen
,
Abdel, Matthew P.
in
Aged
,
Arthroplasty, Replacement, Knee - adverse effects
,
Arthroplasty, Replacement, Knee - instrumentation
2014
Background
Patient-specific instrumentation in TKA has the proposed benefits of improving coronal and sagittal alignment and rotation of the components. In contrast, the literature is inconsistent if the use of patient-specific instrumentation improves alignment in comparison to conventional instrumentation. Depending on the manufacturer, patient-specific instrumentation is based on either MRI or CT scans. However, it is unknown whether one patient-specific instrumentation approach is more accurate than the other and if there is a potential benefit in terms of reduction of duration of surgery.
Questions/purposes
We compared the accuracy of MRI- and CT-based patient-specific instrumentation with conventional instrumentation and with each other in TKAs. The three approaches also were compared with respect to validated outcomes scores and duration of surgery.
Methods
A randomized clinical trial was conducted in which 90 patients were enrolled and divided into three groups: CT-based, MRI-based patient-specific instrumentation, and conventional instrumentation. The groups were not different regarding age, male/female sex distribution, and BMI. In all groups, coronal and sagittal alignments were measured on postoperative standing long-leg and lateral radiographs. Component rotation was measured on CT scans. Clinical outcomes (Knee Society and WOMAC scores) were evaluated preoperatively and at a mean of 3 months postoperatively and the duration of surgery was analyzed for each patient. MRI- and CT-based patient-specific instrumentation groups were first compared with conventional instrumentation, the patient-specific instrumentation groups were compared with each other, and all three approaches were compared for clinical outcome measures and duration of surgery.
Results
Compared with conventional instrumentation MRI- and CT-based patient-specific instrumentation showed higher accuracy regarding the coronal limb axis (MRI versus conventional, 1.0° [range, 0°–4°] versus 4.5° [range, 0°–8°], p < 0.001; CT versus conventional, 3.0° [range, 0°–5°] versus 4.5° [range, 0°–8°], p = 0.02), femoral rotation (MRI versus conventional, 1.0° [range, 0°–2°] versus 4.0° [range, 1°–7°], p < 0.001; CT versus conventional, 1.0° [range, 0°–2°] versus 4.0° [range, 1°–7°], p < 0.001), and tibial slope (MRI versus conventional, 1.0° [range, 0°–2°] versus 3.5° [range, 1°–7°], p < 0.001; CT versus conventional, 1.0° [range, 0°–2°] versus 3.5° [range, 1°–7°], p < 0.001), but the differences were small. Furthermore, MRI-based patient-specific instrumentation showed a smaller deviation in the postoperative coronal mechanical limb axis compared with CT-based patient-specific instrumentation (MRI versus CT, 1.0° [range, 0°–4°] versus 3.0° [range, 0°–5°], p = 0.03), while there was no difference in femoral rotation or tibial slope. Although there was a significant reduction of the duration of surgery in both patient-specific instrumentation groups in comparison to conventional instrumentation (MRI versus conventional, 58 minutes [range, 53–67 minutes] versus 76 minutes [range, 57–83 minutes], p < 0.001; CT versus conventional, 63 minutes [range, 59–69 minutes] versus 76 minutes [range, 57–83 minutes], p < .001), there were no differences in the postoperative Knee Society pain and function and WOMAC scores among the groups.
Conclusions
Although this study supports that patient-specific instrumentation increased accuracy compared with conventional instrumentation and that MRI-based patient-specific instrumentation is more accurate compared with CT-based patient-specific instrumentation regarding coronal mechanical limb axis, differences are only subtle and of questionable clinical relevance. Because there are no differences in the long-term clinical outcome or survivorship yet available, the widespread use of this technique cannot be recommended.
Level of Evidence
Level I, therapeutic study. See the Instructions to Authors for a complete description of levels of evidence.
Journal Article
Robotic-assisted TKA Reduces Postoperative Alignment Outliers and Improves Gap Balance Compared to Conventional TKA
by
Yim, Ji-Hyeon
,
Netravali, Nathan A.
,
Seon, Jong-Keun
in
Aged
,
Arthroplasty, Replacement, Knee - instrumentation
,
Arthroplasty, Replacement, Knee - methods
2013
Background
Several studies have shown mechanical alignment influences the outcome of TKA. Robotic systems have been developed to improve the precision and accuracy of achieving component position and mechanical alignment.
Questions/purposes
We determined whether robotic-assisted implantation for TKA (1) improved clinical outcome; (2) improved mechanical axis alignment and implant inclination in the coronal and sagittal planes; (3) improved the balance (flexion and extension gaps); and (4) reduced complications, postoperative drainage, and operative time when compared to conventionally implanted TKA over an intermediate-term (minimum 3-year) followup period.
Methods
We prospectively randomized 100 patients who underwent unilateral TKA into one of two groups: 50 using a robotic-assisted procedure and 50 using conventional manual techniques. Outcome variables considered were postoperative ROM, WOMAC scores, Hospital for Special Surgery (HSS) knee scores, mechanical axis alignment, flexion/extension gap balance, complications, postoperative drainage, and operative time. Minimum followup was 41 months (mean, 65 months; range, 41–81 months).
Results
There were no differences in postoperative ROM, WOMAC scores, and HSS knee scores. The robotic-assisted group resulted in no mechanical axis outliers (> ± 3° from neutral) compared to 24% in the conventional group. There were fewer robotic-assisted knees where the flexion gap exceeded the extension gap by 2 mm. The robotic-assisted procedures took an average of 25 minutes longer than the conventional procedures but had less postoperative blood drainage. There were no differences in complications between groups.
Conclusions
Robotic-assisted TKA appears to reduce the number of mechanical axis alignment outliers and improve the ability to achieve flexion-extension gap balance, without any differences in clinical scores or complications when compared to conventional manual techniques.
Level of Evidence
Level I, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.
Journal Article
Trial of Vancomycin and Cefazolin as Surgical Prophylaxis in Arthroplasty
by
Mulford, Jonathan
,
Buising, Kirsty L.
,
Spelman, Tim
in
Adult
,
Anti-Bacterial Agents - adverse effects
,
Anti-Bacterial Agents - therapeutic use
2023
In this double-blind, randomized trial, vancomycin was added to cefazolin as surgical prophylaxis for arthroplasty. Surgical-site infections occurred in 4.5% of vancomycin recipients and 3.5% of placebo recipients.
Journal Article
Clinical evaluation of usefulness and effectiveness of sitting-type continuous passive motion machines in patients with total knee arthroplasty: a dual-center randomized controlled trial
by
Kim, Young Mo
,
Choi, Woo Sung
,
Lee, Byung Chan
in
Aged
,
Arthroplasty (knee)
,
Arthroplasty, Replacement, Knee - instrumentation
2024
Background
Total knee arthroplasty (TKA) is a treatment option for osteoarthritis of the knee. After undergoing TKA, patients can be treated with continuous passive motion (CPM); however, inconsistent results have been reported on the effectiveness of CPM as part of a rehabilitation strategy. This discrepancy may be due to the difference between the set-arc of CPM and real arcs of knee motion. In this randomized controlled trial, we compared the efficacy of the sitting-type CPM, which can apply a more fitted arc of motion, to that of the conventional CPM.
Methods
We performed a prospective, multicenter, single-blind, three-arm, randomized controlled trial. Patients who underwent unilateral TKA were recruited and randomly allocated to three groups (151 participants; Group 1, conventional type; Group 2, mixed; and Group 3, sitting type). All participants underwent 10 days of CPM management. Passive and active ranges of motion (ROMs), pain, lower-extremity edema, patient-reported outcomes, and functional assessments were evaluated at four time points.
Results
Passive and active ROMs and pain significantly improved during and after the intervention in all groups; however, no significant differences were noted between the groups. Compared with the conventional type, the sitting-type CPM devices were rated higher in participant’s satisfaction questionnaires.
Conclusion
The sitting-type CPM had equivalent efficacy to that of the conventional-type CPM but provided higher satisfaction to patients after TKA. Therefore, the sitting-type CPM may be a useful tool in post-TKA rehabilitation.
Clinical trial registration
This clincial trial was registed with the Clinical Research Information Service of Republic of Korea, KCT0005520, Registered on 21 October 2020, date of first enrollment at 10/11/2020
https://cris.nih.go.kr/cris/search/detailSearch.do/21750
.
Journal Article