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"Knee surgery"
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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
Robotic-assisted TKA leads to a better prosthesis alignment and a better joint line restoration as compared to conventional TKA: a prospective randomized controlled trial
by
Vaidya, Narendra V.
,
Patil, Rakesh
,
Patil, Pratik
in
Alignment
,
Arthroplasty (knee)
,
Arthroplasty, Replacement, Knee - methods
2022
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.
Journal Article
No difference between resurfaced and non-resurfaced patellae with a modern prosthesis design: a prospective randomized study of 250 total knee arthroplasties
by
Neyret, Philippe
,
Sappey-Marinier, Elliot
,
Lustig, Sébastien
in
Arthroplasty, Replacement, Knee - methods
,
Biomechanics
,
Engineering Sciences
2022
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.
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
Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial
by
Teuke, Joanna
,
Dean, Suzy
,
Clifton, Rupert
in
Anterior cruciate ligament
,
Anterior Cruciate Ligament Injuries - diagnosis
,
Anterior Cruciate Ligament Injuries - etiology
2022
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.
Journal Article
Surgery versus Physical Therapy for a Meniscal Tear and Osteoarthritis
by
Guermazi, Ali
,
Solomon, Daniel H
,
Jones, Morgan H
in
Arthritis
,
Biological and medical sciences
,
Bone surgery
2013
This trial compared surgery with physical therapy (followed by surgery as needed) in patients with a meniscal tear and mild-to-moderate knee osteoarthritis. Functional outcomes and pain were similar in the two groups at 6 months; 30% of the PT group crossed over to surgery.
Symptomatic, radiographically confirmed osteoarthritis of the knee affects more than 9 million people in the United States.
1
Meniscal tears are also highly prevalent, with imaging evidence of a meniscal tear observed in 35% of persons older than 50 years of age; two thirds of these tears are asymptomatic.
2
Meniscal damage is especially prevalent among persons with osteoarthritis
3
,
4
and is frequently treated surgically with arthroscopic partial meniscectomy. This procedure, in which the surgeon trims the torn meniscus back to a stable rim, is performed for a range of indications in more than 465,000 persons annually in the United States.
5
The . . .
Journal Article
Therapeutic effect of knee extension exercise with single-joint hybrid assistive limb following total knee arthroplasty: a prospective, randomized controlled trial
2024
The single-joint hybrid assistive limb (HAL-SJ), an exoskeletal robotic suit, offers functional improvement. In this prospective randomized controlled trial, we investigated the therapeutic effects of knee extension exercises using the HAL-SJ after total knee arthroplasty (TKA). Seventy-six patients with knee osteoarthritis were randomly assigned to HAL-SJ or conventional physical therapy (CPT) groups. The HAL-SJ group underwent exercise using the HAL-SJ for 10 days postoperatively, in addition to CPT; the CPT group underwent only CPT. Pain intensity and active and passive knee extension angles were evaluated preoperatively and on postoperative days 1–10 and weeks 2 and 4. Performance tests and Knee Injury and Osteoarthritis Outcome Scores (KOOS) were evaluated preoperatively and at postoperative weeks 2 and 4. Statistical analysis showed that the HAL-SJ group significantly improved active and passive knee extension angles compared with the CPT group. The HAL-SJ group showed immediate improvement in active knee extension angle through day 5. There were no significant differences in results between the performance tests and KOOS. Knee extension exercises with the HAL-SJ improved knee pain and the angle of extension in the acute phase after TKA.
Journal Article
A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years
by
Grifka, Joachim
,
Volz, Martin
,
Anders, Sven
in
Adult
,
Arthroplasty, Subchondral - rehabilitation
,
Bone marrow
2017
Purpose
Autologous Matrix-Induced Chondrogenesis (AMIC
®
) utilizing a type I/III collagen membrane was compared with microfracture (MFx) alone in focal cartilage lesions of the knee at one, two and five years.
Methods
Forty-seven patients (aged 37 ± 10 years, mean defect size 3.6 ± 1.6 cm
2
) were randomized and treated either with MFx, with sutured or glued AMIC
®
in a prospective multicentre clinical trial.
Results
After improvement for the first two years in all subgroups, a progressive and significant score degradation was observed in the MFx group, while all functional parameters remained stable for least five years in the AMIC
®
groups. At two and five years, MRI defect filling was more complete in the AMIC
®
groups. No treatment-related adverse events were reported.
Conclusions
AMIC
®
is an effective cartilage repair procedure in the knee resulting in stable clinical results significantly better than the MFx group at five years.
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
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