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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.

Anterior cruciate ligament (ACL) rupture is a common debilitating injury that can cause instability of the knee. We aimed to investigate the best management strategy between reconstructive surgery and non-surgical treatment for patients with a non-acute ACL injury and persistent symptoms of instability. We did a pragmatic, multicentre, superiority, randomised controlled trial in 29 secondary care National Health Service orthopaedic units in the UK. Patients with symptomatic knee problems (instability) consistent with an ACL injury were eligible. We excluded patients with meniscal pathology with characteristics that indicate immediate surgery. Patients were randomly assigned (1:1) by computer to either surgery (reconstruction) or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment), stratified by site and baseline Knee Injury and Osteoarthritis Outcome Score—4 domain version (KOOS4). This management design represented normal practice. The primary outcome was KOOS4 at 18 months after randomisation. The principal analyses were intention-to-treat based, with KOOS4 results analysed using linear regression. This trial is registered with ISRCTN, ISRCTN10110685, and ClinicalTrials.gov, NCT02980367. Between Feb 1, 2017, and April 12, 2020, we recruited 316 patients. 156 (49%) participants were randomly assigned to the surgical reconstruction group and 160 (51%) to the rehabilitation group. Mean KOOS4 at 18 months was 73·0 (SD 18·3) in the surgical group and 64·6 (21·6) in the rehabilitation group. The adjusted mean difference was 7·9 (95% CI 2·5–13·2; p=0·0053) in favour of surgical management. 65 (41%) of 160 patients allocated to rehabilitation underwent subsequent surgery according to protocol within 18 months. 43 (28%) of 156 patients allocated to surgery did not receive their allocated treatment. We found no differences between groups in the proportion of intervention-related complications. Surgical reconstruction as a management strategy for patients with non-acute ACL injury with persistent symptoms of instability was clinically superior and more cost-effective in comparison with rehabilitation management. The UK National Institute for Health Research Health Technology Assessment Programme.

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.

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 Neutral mechanical alignment (MA) in total knee arthroplasty (TKA) aims to position femoral and tibial components perpendicular to the mechanical axis of the limb. In contrast, kinematic alignment (KA) attempts to match implant position to the prearthritic anatomy of the individual patient with the aim of improving functional outcome. However, comparative data between the two techniques are lacking. Questions/purposes In this randomized trial, we asked: (1) Are 2-year patient-reported outcome scores enhanced in patients with KA compared with an MA technique? (2) How does postoperative component alignment differ between the techniques? (3) Is the proportion of patients undergoing reoperation at 2 years different between the techniques? Methods Ninety-nine primary TKAs in 95 patients were randomized to either MA (n = 50) or KA (n = 49) groups. A pilot study of 20 TKAs was performed before this trial using the same patient-specific guides positioning in kinematic alignment. In the KA group, patient-specific cutting blocks were manufactured using individual preoperative MRI data. In the MA group, computer navigation was used to ensure neutral mechanical alignment accuracy. Postoperative alignment was assessed with CT scan, and functional scores (including the Oxford Knee Score, WOMAC, and the Forgotten Joint Score) were assessed preoperatively and at 6 weeks, 6 months, and 1 and 2 years postoperatively. No patients were lost to followup. We set sample size at a minimum of 45 patients per treatment arm based on a 5-point improvement in the mean Oxford Knee Score (OKS; the previously reported minimum clinically significant difference for the OKS in TKA), a pooled SD of 8.3, 80% power, and a two-sided significance level of 5%. Results We observed no difference in 2-year change scores (postoperative minus preoperative score) in KA versus MA patients for the OKS (mean 21, SD 8 versus 20, SD 8, least square means 1.0, 95% confidence interval [CI], −1.4 to 3.4, p = 0.4), WOMAC score (mean 38, SD 18 versus 35, SD 8, least square means 3, 95% CI, −3.2 to 8.9, p = 0.3), or Forgotten Joint score (28 SD 37 versus 28, SD 28, least square means 0.8, 95% CI, −9.1–10.7, p = 0.8). Postoperative hip-knee-ankle axis was not different between groups (mean KA 0.4° varus SD 3.5 versus MA 0.7° varus SD 2.0), but in the KA group, the tibial component was a mean 1.9° more varus than the MA group (95% CI, 0.8°−3.0°, p = 0.003) and the femoral component in 1.6° more valgus (95% CI, −2.5° to −0.7°, p = 0.003). Complication rates were not different between groups. Conclusions We found no difference in 2-year patient-reported outcome scores in TKAs implanted using the KA versus an MA technique. The theoretical advantages of improved pain and function that form the basis of the design rationale of KA were not observed in this study. Currently, it is unknown whether the alterations in component alignment seen with KA will compromise long-term survivorship of TKA. In this study, we were unable to demonstrate an advantage to KA in terms of pain or function that would justify this risk. Level of Evidence Level I, therapeutic study.

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.

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.

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).

Objective The purpose of this study was to compare the clinical and radiological efficacy of autologous adipose-derived stromal vascular fraction (SVF) versus hyaluronic acid in patients with bilateral knee osteoarthritis. Methods Sixteen patients with bilateral symptomatic knee osteoarthritis (K-L grade II to III; initial pain evaluated at four or greater on a ten-point VAS score) were enrolled in this study, which were randomized into two groups. Each patient received 4-ml autologous adipose-derived SVF treatment (group test, n  = 16) in one side of knee joints and a single dose of 4-ml hyaluronic acid treatment (group control, n  = 16) in the other side. The clinical evaluations were performed pre-operatively and post-operatively at one month, three months, six months, and 12-months follow-up visit, using the ten-point visual analog scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the knee range of motion (ROM). The whole-organ assessment of the knees was performed with whole-organ magnetic resonance imaging score (WORMS) based on MRI at baseline, six months and 12-months follow-up. The articular repair tissue was assessed quantitatively and qualitatively by magnetic resonance observation of cartilage repair tissue (MOCART) score based on follow-up MRI at six months and 12 months. Results No significant baseline differences were found between two groups. Safety was confirmed with no severe adverse events observed during 12-months follow-up. The SVF-treated knees showed significantly improvement in the mean VAS, WOMAC scores, and ROM at 12-months follow-up visit compared with the baseline. In contrast, the mean VAS, WOMAC scores, and ROM of the control group became even worse but not significant from baseline to the last follow-up visit. WORMS and MOCART measurements revealed a significant improvement of articular cartilage repair in SVF-treated knees compared with hyaluronic acid-treated knees. Conclusion The results of this study suggest that autologous adipose-derived SVF treatment is safe and can effectively relief pain, improve function, and repair cartilage defects in patients with knee osteoarthritis.

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.