A Prospective Randomised Control Trial Comparing Functional with Mechanical Axis Alignment in Total Knee Arthroplasty: study protocol for an investigator initiated trial

2021 ◽  
Author(s):  
Richard Steer ◽  
Beth Tippett ◽  
R Nazim Khan ◽  
Dermot Collopy ◽  
Gavin Clark
Keyword(s):  
Total Knee Arthroplasty ◽  
Soft Tissue ◽  
Knee Arthroplasty ◽  
Functional Outcomes ◽  
Medical Information ◽  
Randomised Control Trial ◽  
Computer Assisted ◽  
Patient Reported ◽  
Total Knee ◽  
Alternative Alignment

Abstract Background: A drive to improve functional outcomes for patients undergoing total knee arthroplasty (TKA) has led to alternative alignment being used. Functional alignment (FA) uses intraoperative soft tissue tension to determine the optimal position of the prosthesis within the patients soft tissue envelope. Angular limits for bone resections are followed to prevent long term prosthesis failure. This study will use the aid of robotic assistance to plan and implement the final prosthesis position. This method has yet to be compared to the traditional mechanically aligned (MA) knee in a randomised trial. Methods: A blinded randomised control trial with 100 patients will be undertaken via Perth Hip and Knee clinic. Fifty patients will undergo a MA TKA and fifty will undergo a FA TKA. Both alignment techniques will be balanced via computer assisted navigation to assess prosthetic gaps, being achieved via the initial bony resection and further soft tissue releases as required to achieve satisfactory balance. The primary outcome will be the forgotten joint score (FJS) two years after surgery, with secondary outcomes being other patient reported outcome measures, clinical functional assessment, radiographic position and complications. Other data that will be collected will be patient demography (Sex, Age, level of activity) and medical information (grade of knee injury, any other relevant medical information). The linear statistical model will be fitted to the response (FJS), including all the other variables as covariates. Discussion: Many surgeons are utilising alternative alignment techniques with a goal of achieving better functional outcomes for their patients. Currently MA TKA remains the gold standard with good outcomes and excellent longevity. There is no published RCTs comparing FA to MA yet and only two registered studies are planned or currently in progress. This study utilizes a FA technique which differs from the two studies. This study will help determine if FA TKA has superior functional results for patients.Trial registration: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) http://www.anzctr.org.au: U1111-1257-2291, registered 25th Jan 2021. It is also listed on www.clinicaltrials.gov: NCT04748510

scholarly journals A prospective randomised control trial comparing functional with mechanical axis alignment in total knee arthroplasty: study protocol for an investigator initiated trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Richard Steer ◽  
Beth Tippett ◽  
R. Nazim Khan ◽  
Dermot Collopy ◽  
Gavin Clark
Keyword(s):  
Total Knee Arthroplasty ◽  
Soft Tissue ◽  
Knee Arthroplasty ◽  
Functional Outcomes ◽  
Medical Information ◽  
Randomised Control Trial ◽  
Computer Assisted ◽  
Link Type ◽  
Total Knee ◽  
Alternative Alignment

Abstract Background A drive to improve functional outcomes for patients undergoing total knee arthroplasty (TKA) has led to alternative alignment being used. Functional alignment (FA) uses intraoperative soft tissue tension to determine the optimal position of the prosthesis within the patient’s soft tissue envelope. Angular limits for bone resections are followed to prevent long-term prosthesis failure. This study will use the aid of robotic assistance to plan and implement the final prosthesis position. This method has yet to be compared to the traditional mechanically aligned (MA) knee in a randomised trial. Methods A blinded randomised control trial with 100 patients will be undertaken via Perth Hip and Knee Clinic. Fifty patients will undergo a MA TKA and fifty will undergo a FA TKA. Both alignment techniques will be balanced via computer-assisted navigation to assess prosthetic gaps, being achieved via the initial bony resection and further soft tissue releases as required to achieve satisfactory balance. The primary outcome will be the Forgotten Joint Score (FJS) 2 years after surgery, with secondary outcomes being other patient-reported outcome measures, clinical functional assessment, radiographic position and complications. Other data that will be collected will be patient demography (sex, age, level of activity) and medical information (grade of knee injury, any other relevant medical information). The linear statistical model will be fitted to the response (FJS), including all the other variables as covariates. Discussion Many surgeons are utilising alternative alignment techniques with a goal of achieving better functional outcomes for their patients. Currently, MA TKA remains the gold standard with good outcomes and excellent longevity. There is no published RCTs comparing FA to MA yet and only two registered studies are planned or currently in progress. This study utilises a FA technique which differs from the two studies. This study will help determine if FA TKA has superior functional results for patients. Trial registration This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) http://www.anzctr.org.au: U1111-1257-2291, registered 25th Jan 2021. It is also listed on www.clinicaltrials.gov: NCT04748510.

Can isolated removal of osteophytes achieve correction of varus deformity and gap-balance in computer-assisted total knee arthroplasty?

2020 ◽  
Vol 102-B (6_Supple_A) ◽  
pp. 49-58
Author(s):  
Arun Mullaji
Keyword(s):  
Total Knee Arthroplasty ◽  
Soft Tissue ◽  
Knee Arthroplasty ◽  
Medial Collateral Ligament ◽  
Knee Flexion ◽  
Deformity Correction ◽  
Computer Assisted ◽  
Cruciate Ligaments ◽  
Collateral Ligament ◽  
Total Knee

Aims The aims of this study were to determine the effect of osteophyte excision on deformity correction and soft tissue gap balance in varus knees undergoing computer-assisted total knee arthroplasty (TKA). Methods A total of 492 consecutive, cemented, cruciate-substituting TKAs performed for varus osteoarthritis were studied. After exposure and excision of both cruciates and menisci, it was noted from operative records the corrective interventions performed in each case. Knees in which no releases after the initial exposure, those which had only osteophyte excision, and those in which further interventions were performed were identified. From recorded navigation data, coronal and sagittal limb alignment, knee flexion range, and medial and lateral gap distances in maximum knee extension and 90° knee flexion with maximal varus and valgus stresses, were established, initially after exposure and excision of both cruciate ligaments, and then also at trialling. Knees were defined as ‘aligned’ if the hip-knee-ankle axis was between 177° and 180°, (0° to 3° varus) and ‘balanced’ if medial and lateral gaps in extension and at 90° flexion were within 2 mm of each other. Results Of 50 knees (10%) with no soft tissue releases (other than cruciate ligaments), 90% were aligned, 81% were balanced, and 73% were aligned and balanced. In 288 knees (59%) only osteophyte excision was performed by subperiosteally releasing the deep medial collateral ligament. Of these, 98% were aligned, 80% were balanced, and 79% were aligned and balanced. In 154 knees (31%), additional procedures were performed (reduction osteotomy, posterior capsular release, and semimembranosus release). Of these, 89% were aligned, 68% were balanced, and 66% were aligned and balanced. The superficial medial collateral ligament was not released in any case. Conclusion Two-thirds of all knees could be aligned and balanced with release of the cruciate ligaments alone and excision of osteophytes. Excision of osteophytes can be a useful step towards achieving deformity correction and gap balance without having to resort to soft tissue release in varus knees while maintaining classical coronal and sagittal alignment of components. Cite this article: Bone Joint J 2020;102-B(6 Supple A):49–58.

scholarly journals The influence of tibiofemoral joint forces on patient-reported outcome measurements after bicruciate stabilized total knee arthroplasty

2020 ◽  
Vol 28 (2) ◽  
pp. 230949902091510
Author(s):  
Takao Kaneko ◽  
Norihiko Kono ◽  
Yuta Mochizuki ◽  
Masaru Hada ◽  
Shinya Toyoda ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Soft Tissue ◽  
Knee Arthroplasty ◽  
Patient Reported Outcome ◽  
Neutral Position ◽  
Positive Correlation ◽  
Outcome Measurements ◽  
Patient Reported ◽  
Total Knee ◽  
The Relationship

Objective: Insall advocated that a successful clinical outcome of total knee arthroplasty (TKA) depends on soft tissue balance procedure. Spacer blocks, balancer, and instrumented tibial sensor (VERESENSE, OrthoSensor, Dania, Florida, USA) are the current methods of soft tissue balancing during TKA. The purpose of the study is to assess intraoperative medial and lateral tibiofemoral compressive force (TFCF) using novel insert sensor and investigate the relationship between TFCF and patient-reported outcome measurements (PROMs). Methods: Twenty-five patients who underwent bicruciate stabilized (BCS) TKA were evaluated retrospectively. We measured intraoperative medial and lateral TFCF in neutral position as well as the force ratio (FR %:medial TFCF/medial + lateral TFCF) in varus and valgus position using the novel insert sensor throughout the range of motion (ROM) and assessed the relationship between intraoperative medial and lateral TFCF and PROM at 6 months after TKA. Results: Medial TFCF increased and lateral TFCF decreased throughout ROM. The mean FR was 0.44% ± 0.22 throughout ROM. Medial and lateral TFCF differences at 60° of ROM in neutral position showed a positive correlation with physical function in Western Ontario and McMaster Universities scores ( r = 0.60, p < 0.05). Medial and lateral TFCF differences at 30° and 140° of ROM in valgus stress test showed a positive correlation with symptoms in 2011 Knee Society Scores ( r = 0.49, p < 0.05; r = 0.51, p < 0.05). Conclusion: The present study revealed that BCS TKA reproduces the coronal laxity, which is similar to healthy knee. These results suggest that intraoperative medial stability is important for function and symptoms, therefore, surgeons should not release medial soft tissue for achieving better clinical outcomes after BCS TKA. Level of Evidence: II

Highly Satisfied Total Knee Arthroplasty Patients Display a Wide Range of Soft Tissue Balance

2019 ◽  
Vol 33 (03) ◽  
pp. 247-254 ◽  
Author(s):  
Michael J. McAuliffe ◽  
Patrick B. O'Connor ◽  
Lisa J. Major ◽  
Gautam Garg ◽  
Sarah L. Whitehouse ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Soft Tissue ◽  
Knee Arthroplasty ◽  
Individual Variability ◽  
Measured Parameter ◽  
Computer Assisted ◽  
Maximum Extension ◽  
Wide Range ◽  
Coronal Laxity ◽  
Total Knee

AbstractSoft tissue balancing while crucial for a successful total knee arthroplasty (TKA) is incompletely defined and the subject of broad recommendations. We analyzed 69 unilateral computer-assisted surgery posterior stabilized (PS) TKA subjects who postoperatively scored ≥36 out of a possible 40 points on the satisfaction section of the American Knee Society score (2011). We examined a range of postoperative coronal plane laxity parameters and the correlation between preoperative and postoperative laxity. Total postoperative coronal laxity arcs at maximum extension and 20 degrees of flexion varied between 2 and 12 and 3 and 13 degrees, respectively. Depending on the position of measurement, medial laxity was between 0.5 and 9.5 degrees and lateral laxity between 1 and 12 degrees. The change in laxity between maximum extension and 90 degrees of flexion demonstrated a range of 7 degrees medially and 12 degrees laterally. The total coronal arc of movement did not affect functional outcomes. A moderate correlation of 0.452 and 0.424 was seen between initial and postoperative total coronal laxity arcs in maximum extension and 20 degrees of flexion, respectively. The individual variability for each measured parameter within our cohort demonstrates TKA satisfaction is not as simple as producing a narrow range of coronal laxity parameters and that as with many body systems considerable variation is still consistent with excellent function. Our findings help to define acceptable balance parameters for PS TKA. It does not appear necessary to closely match postoperative laxity to that present preoperatively.

Assessing Short-Term Functional Outcomes and Knee Alignment of Computer-Assisted Navigated Total Knee Arthroplasty

2012 ◽  
Vol 27 (2) ◽  
pp. 271-277 ◽  
Author(s):  
M. Moin Khan ◽  
M. Wahab Khan ◽  
Hatem H. Al-Harbi ◽  
Brad S. Weening ◽  
Paul K. Zalzal
Keyword(s):  
Total Knee Arthroplasty ◽  
Knee Arthroplasty ◽  
Functional Outcomes ◽  
Computer Assisted ◽  
Knee Alignment ◽  
Short Term ◽  
Total Knee

scholarly journals Computer and robotic – assisted total knee arthroplasty: a review of outcomes

2020 ◽  
Vol 7 (1) ◽  
Author(s):  
Jobe Shatrov ◽  
David Parker
Keyword(s):  
Total Knee Arthroplasty ◽  
Survival Analysis ◽  
Knee Arthroplasty ◽  
Computer Assisted ◽  
Implant Survival ◽  
Robotic Assisted ◽  
Early Results ◽  
Patient Reported ◽  
Total Knee ◽  
Term Data

Abstract Background Total knee arthroplasty (TKA) is a successful treatment for tricompartmental knee arthritis. Computer navigation and robotic-assisted-surgery (RAS) have emerged as tools that aim to help plan and execute surgery with greater precision and consistency. We reviewed the most current literature to describe the historical background and outcomes compared to conventional TKA. Methods A review and synthesis of the literature comparing the patient reported outcomes (PROM’s) of RA TKA and computer-assisted (CA) TKA to conventional TKA was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results CAS TKA improves accuracy and consistency of implant position, and appears to provide a small improvement in PROMs and implant survival compared to conventional TKA. RTKA similarly improves implant accuracy compared to conventional techniques and early results suggest a similar small benefit in PROMs compared to conventional TKA. A strengthening trend is emerging showing CAS TKA has greatest benefit to implant survival in people under 65. RTKA survival analysis data is more limited and early results do not allow strong conclusions, however early trends are similar to CAS TKA. Conclusion Results for CAS-TKA show improvement in alignment, and early clinical outcomes have revealed promising results, with longer-term data and medium-term survival analysis recently emerging showing small benefits over conventional TKA. RTKA represents another phase of development. Early results show similar trends to that of CAS TKA with longer-term data still to come.

scholarly journals Coronal Knee Laxity Measured During Computer-Assisted Total Knee Arthroplasty

10.29007/mdm5 ◽  
2018 ◽  
Author(s):  
Yifei Dai ◽  
Guillaume Bras ◽  
David Liu
Keyword(s):  
Total Knee Arthroplasty ◽  
Soft Tissue ◽  
Knee Arthroplasty ◽  
Knee Laxity ◽  
Computer Assisted ◽  
Clinical Implications ◽  
Valgus Knee ◽  
Soft Tissue Management ◽  
Soft Tissue Laxity ◽  
Total Knee

This observational study on fifty-six patients presents the coronal knee angular laxity measured during computer-assisted total knee arthroplasty. Varus/valgus knee laxity was assessed at extension, mid-flexion, and high flexion, and compared between arthritic knees and knees following trial TKA implantation. The data represented soft tissue laxity under surgical reality and may be used to further understand the clinical implications of intraoperative soft-tissue management. The findings highlight the potential for CAOS to accurately manage soft tissue balance in addition to bony cuts and overall alignment.

scholarly journals One and Two Year Postoperative Patient Reported Outcomes of Robotic-Assisted Total Knee Arthroplasty

10.29007/n4qv ◽  
2019 ◽  
Author(s):  
Christopher Blum ◽  
Christopher Plaskos ◽  
Adil Hussein ◽  
Jan A Koenig
Keyword(s):  
Total Knee Arthroplasty ◽  
Knee Arthroplasty ◽  
Patient Reported Outcomes ◽  
Computer Assisted ◽  
Robotic Assisted ◽  
Post Surgery ◽  
Patient Reported ◽  
National Cohort ◽  
Total Knee ◽  
And Function

Total knee arthroplasty is a successful procedure. However, there is still area for improvement as up to 15-20% of patients remain unsatisfied. Robotic-assisted surgery (RAS) may improve patient outcomes by providing a reproducible way of obtaining neutral mechanical alignment of the limb, which has been shown to reduce early revisions and correlate with patient reported outcomes after surgery.We prospectively enrolled 106 patients undergoing robotic-assisted TKA by a single surgeon performing a measured-resection femur-first technique using the OMNIBotic system. Patients completed a KOOS and New Knee Society Score (KSS) pre-operatively and at 3, 6, 12, and 24 months (M) postoperatively. Changes in the five KOOS sub-scales were compared to available literature data from the FORCE – TJR cohort, as well as to individual studies reporting on conventional and computer-assisted TKA.When compared to FORCE-TJR 6-month (M) and 2-year (Y) data, the RAS cohort had significantly higher improvements at 6M for pain (40.5 vs. 31.1, p&lt;.001) and at 2Y for all five KOOS sub-scores. The larger improvement was due to the RAS cohort having lower baseline KOOS scores than the FORCE-TJR cohort, except for the Sports-Recreation sub-score, which was similar pre- operatively but significantly higher post-operatively for the robotic cohort. Rates of dissatisfaction with knee pain level and function using the KSS after RAS were 3.0%, 1.0%, and 2.7% at 6, 12, and 24M postoperatively, respectively.Despite having poorer joint function and higher pain pre-operatively, robotic-assisted TKA patients achieved excellent self-reported outcomes, with significantly higher levels of improvement through two years post-surgery when compared with large national cohort studies. Further controlled clinical studies are warranted to determine if these results translate to other groups of surgeons, centers and patients.

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