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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.

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.

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.

Purpose Despite numerous well-conducted studies and meta-analyses, the management of the patella during total knee arthroplasty (TKA) remains controversial. The aim of our study was to compare the clinical and radiological outcomes between patients with and without patellar resurfacing and to determine the influence of resurfacing on patellar tracking with a “patella-friendly” prosthesis. Methods A single-centered prospective randomized controlled study was performed between April 2017 and November 2018. Two hundred and forty-five consecutive patients (250 knees) scheduled for TKA were randomized for patellar resurfacing or patella non-resurfacing. All patients received the same total knee prosthesis and were evaluated clinically and radiologically, including the International Knee Society Score (KSS knee and function), Forgotten Joint Score (FJS), anterior knee pain (AKP), pain when climbing stairs, patellar tilt, and patellar translation. Results Two hundred and twenty-nine knees were available for clinical evaluation and 221 knees for radiographic analysis. The revision rate for patellofemoral cause was 3.1% (7 cases) with no difference between the groups ( p  = 0.217). There was no difference in survival rate between patellar resurfacing (88.3%) and non-resurfacing (85.3%) after 24 months ( p  = 0.599). There were no differences in KSS functional component ( p  = 0.599), KSS knee component ( p  = 0.396), FJS ( p  = 0.798), and AKP ( p  = 0.688) at a mean follow-up of 18 months. There was twice as much stair pain for the non-resurfacing group (17.1% versus 8.5%) ( p  = 0.043). There was patellar tilt in 43% of resurfaced knees ( n  = 50/116) versus 29% in non-resurfaced knees ( n  = 30/105) ( p  = 0.025); however, there was more patellar translation in the non-resurfaced group (21.0% versus 7.8%) ( p  < 0.001). There were no specific complications attributed to the patellar resurfacing procedure. There were four secondary patellar resurfacing procedures (3.6%) in the non-resurfaced group after a mean of 10 ± 7 months (1–17) postoperatively. Conclusion There is no superiority of patellar resurfacing or non-resurfacing in terms of clinical or radiological outcomes at mid-term. Secondary patellar resurfacing is rare. There is not enough evidence to recommend systematic patellar resurfacing with a “patella-friendly” prosthesis. Level of evidence 1.

BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. METHODSThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. RESULTSThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRSpain reduction 50% or greater74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. CONCLUSIONSThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.Clinical Trial RegistrationClinicalTrials.gov (NCT02343003).

Purpose To determine whether knee stability, range of motion (ROM) and clinical scores differ between anterior-stabilized (AS) and posterior-stabilized (PS) total knee arthroplasty (TKA). Methods This prospective randomized controlled trial included 34 patients with severe bilateral knee osteoarthritis who underwent bilateral TKA between June 2010 and July 2011 using AS and PS designs of a single-implant system. AS TKA with ultracongruent inserts was performed in one knee and PS TKA with a cam-post mechanism was performed in the other knee in each patient. Clinical and radiological data from a mean follow-up period of 5 years, including ROM, clinical scores, peak knee torque determined by isokinetic test, knee joint laxity determined by Telos stress views, tourniquet time and subjects’ preference were analyzed. Results The mean postoperative knee flexion angle did not differ between groups until 1 year. Beginning 2 years postoperatively, the knee flexion angle decreased slightly in the AS group and was smaller than that in the PS group ( p  = 0.004). The mean Knee Society knee score was higher in the PS group than in the AS group after 2 years. The quadriceps strength did not differ between groups. The mean posterior laxity after TKA was 6–8 mm greater in the AS group than in the PS group. No radiological loosening was observed in either group. More subjects preferred PS knees to AS knees. However, this difference was not significant. Conclusion AS primary TKA was inferior to PS TKA in terms of posterior knee stability, postoperative knee flexion and clinical scores after 2 years. Level of evidence Therapeutic study, Level 1.

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).

Purpose Correct positioning and alignment of the prosthesis is a very important factor for durability of prosthesis and implant survival which is improved with the use of technology in total knee arthroplasty. However, the long-term functional outcomes and survivorship are unclear. For this study, it was hypothesized that mechanical axis alignment of lower limb, post-operative joint line restoration, femoral and tibial component alignment is more accurate with the new handheld semi-active robotic-assisted TKA. Method From April-2019 to March-2020, 60 patients with unilateral knee osteoarthritis who underwent total knee arthroplasties were included in this prospective randomised controlled study. Computer generated randomization was used. Study included 48 female patients and 12 male patients. Pre-operative and post-operative radiographic measurements were done and compared between the two groups. Results There was a significant difference between two groups with respect to mechanical axis deviation, joint line deviation and coronal alignment of femoral and tibial prosthesis. Mechanical axis deviation > 3° was seen in eight cases (28.5%) in C-TKA group compared to one case (3.1%) in RA-TKA ( p 0.019). Joint line deviation of 3.5 mm was noted in C-TKA group as compared to 0.9 mm in RA-TKA group ( p < 0.001) which was statistically significant. However, whether this difference of 2.6 mm of joint line elevation between C-TKA and RA-TKA leads to any difference in clinical outcome in terms of knee kinematics and knee flexion needs to be investigated with further studies. Clinically restoring normal joint line is important for improved knee function after primary TKA. No significant difference was noted in femoral component rotation on post-operative computed tomography (CT) scan. Conclusion The novel imageless, handheld semi-autonomous robotic system for TKA is highly accurate with respect to component positioning in coronal plane and mechanical alignment as compared to conventional TKA. Joint line is elevated in conventional TKA but is accurately restored using the robotic-assisted TKA which may lead to better patellofemoral kinematics. Level of evidence I.

Background The infrapatellar fat pad is one of the structures that obscures exposure in minimally invasive total knee arthroplasty (MIS TKA). Most MIS TKA surgeons (and many surgeons who use other approaches as well) excise the fat pad for better exposure of the knee. There is still controversy about the result of fat pad excision on patella baja, pain, and function. Questions/purposes In the setting of a randomized controlled trial, we sought to determine whether infrapatellar fat pad excision during MIS TKA causes (1) patellar tendon shortening (as measured by patella baja); (2) increased anterior knee pain; (3) decreases in the Knee Society Score or functional subscore; or (4) more patella-related complications. Methods We randomized 90 patients undergoing MIS TKA at one institution into two groups. In one group, 45 patients underwent MIS TKA with complete infrapatellar fat pad excision and in the other group, 45 patients received MIS TKA without infrapatellar fat pad excision. The patella was selectively resurfaced in these patients; there was no difference between the groups in terms of the percentage of patients whose patellae were resurfaced. We measured patellar tendon shortening, knee flexion, anterior knee pain, Knee Society Score (KSS), functional subscore, and patellar complications at preoperative and postoperative periods of 6 weeks, 3 months, 6 months, and 1 year; complete followup data were available on 86% of patients (77 of 90) who were enrolled. Results At the final followup, no significant differences were observed in patellar tendon shortening, KSS, functional subscore, or knee flexion in either group. However, patients with their infrapatellar fat pad excised experienced more anterior knee pain (8.3% versus 0%; p = 0.03; 95% confidence interval, −0.007 to 0.174) at the end of the study. No patellar complications were found in either group. Conclusions Infrapatellar fat pad excision in MIS TKA resulted in an increasing small percentage of patients with anterior knee pain after surgery. Surgeons should keep the fat pad if excellent exposure can be achieved but resect it if needed to improve exposure during TKA. Level of Evidence Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

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.