To quantify the influence of baseline values of a specific patient-reported outcome measure (PROM) on the minimal clinically important difference (MCID) calculation in a homogeneous series of knee osteoarthritis patients treated with platelet-rich plasma (PRP) injections.
A data set of 312 patients with knee osteoarthritis treated with intra-articular PRP injections was used. Patients were evaluated through the International Knee Documentation Committee (IKDC) subjective score at 6 months after treatment. According to the baseline IKDC score, the study population was stratified into eight clusters in the first phase (<20, 20–29, 30–39, 40–49, 50–59, 60–69, 70–79 and ≥80) and in three macro clusters in the second phase (<40, 40–69 and ≥70). MCID for the IKDC score was calculated through an anchor-based method in both phases.
The MCID calculation was performed for the eight clusters according to the baseline IKDC values, obtaining values from 16.2 to −3.1. Afterwards, further MCID calculation was performed after unifying patients in three major clusters based on the similarity of the previously obtained MCID values. Ninety-six patients reported a baseline IKDC score <40, 173 patients between 40 and 70, and 43 patients ≥70. MCID values for the three macro clusters were: 14.6 for patients with baseline IKDC score <40, 7.2 for patients with values between 40 and 69, while patients with values ≥70 reported an MCID value of −2.8.
This study demonstrated that the baseline patient clinical status influences the improvement needed to be perceived as clinically relevant. Patients with a worse baseline clinical status presented higher MCID levels, while MCID lost significance in patients with high baseline clinical values. These findings warrant applying general thresholds to a patients' cohort, showing the remarkable impact of the baseline clinical status. Patient stratification ensures a proper quantification of MCID values and the identification of patients benefiting from the studied treatment.
Level 4.
The functional hip–spine interaction is increasingly noted in hip preservation by periacetabular osteotomy (PAO), while potentially affecting the impingement-free acetabular reorientation. However, the clinically relevant sex-related differences in lumbopelvic alignment have been poorly studied. Thus, the purpose of this study was to evaluate a matched PAO patient cohort for sex-related differences in lumbopelvic alignment.
Out of 138 patients undergoing PAO between January 2024 and September 2024 at one high-volume centre, there were 68 data sets (34 male, 34 female) included. The data sets of this diagnostic cohort study were prospectively collected, and the patients were matched in a 1:1 ratio for sex, age and acetabular morphology (hip dysplasia, borderline hip dysplasia, acetabular retroversion). Lumbopelvic alignment was assessed with serial sagittal lumbopelvic radiographs in standing, relaxed-seated and deep-seated positions. Each radiograph was reviewed for pelvic tilt (PT), lumbar lordosis and sacral slope.
Females showed a significantly lower PT in standing (7.8 vs. 14.3°, p < 0.001), relaxed-seated (28.1 vs. 34.9°, p = 0.012) and deep-seated (3.7 vs. 11.0°, p = 0.013) positions. Furthermore, females had a significantly increased lumbar mobility (Δ relaxed-seated − deep-seated position − 35.4° vs. 27.0°, p = 0.003), while there was no sex-related difference in sacral mobility (p > 0.05).
There are sex-related differences in functional lumbopelvic alignment across various positions of daily living in patients undergoing PAO. With a greater anterior PT, females are at risk of an anterior hip impingement. Thus, the intraoperative anterior and posterior wall reorientation by PAO should be adapted to the sex-related lumbopelvic alignment to ensure an impingement-free surgical outcome.
Level IV, case series.
This study assessed the accuracy and early clinical outcomes of the VELYS™ Robotic-Assisted solution for total knee arthroplasty (TKA).
A multicenter, prospective non-randomized 1:1 cohort study was conducted at five sites. Subjects underwent TKA with either manual instrumentation or with robotic-assistance (RA). RA procedures were the first conducted at each site, therefore, representing the adoption phase for each surgeon. Mechanical alignment was targeted in the manual arm, while the target and technique varied in the RA arm. The primary objective was a non-inferiority (NI) analysis of the accuracy of the hip–knee–ankle (HKA) for RA versus manual, with a 1.5° NI margin. The accuracy of the mechanical medial distal femoral angle (mMDFA), mechanical medial proximal tibial angle (mMPTA) tibial posterior slope (TPS) angles were measured. Adverse events (AEs) and patient-reported outcome measures (PROMs) were collected at 12 weeks and 1 year.
One hundred participants were recruited for both manual and RA groups, the mean preoperative demographics and PROM scores were similar. The primary endpoint NI analysis was successful (p < 0.0001). The RA group demonstrated improved alignment accuracy of the femoral and tibial components compared to manual (mMDFA 1.3 vs. 1.9, p = 0.0026, mMPTA 1.2 vs. 1.5, p = 0.026, TPS 1.7 vs. 2.8, p < 0.0001). Serious AEs occurred in fewer RA subjects than in the manual (6 vs. 16, p = 0.040). Mean PROMs at 12 weeks and 1 year in the RA group compared to manual were either equivalent or improved (Forgotten Joint Score and pain at 12 weeks).
This study found that the RA system can be safely adopted without adversely impacting the long leg alignment or increasing the risk of complications. Further, it was observed that the accuracy of the femoral and tibial component positioning was improved, and there were positive trends in the rate of serious AEs and some PROMs at early follow-up.
Level II.
Current surgical methods for multi-ligament knee reconstruction involve the creation of several reconstruction tunnels in the distal femur. However, the limited bone mass in the knee increases the risk of tunnel convergence. Increasing the accuracy of tunnel direction can minimize tunnel collision during anatomical reconstruction. 3D-printed patient-specific instrumentation (PSI) has gained prominence in orthopaedic surgery due to its precision. This study aims to compare the accuracy of PSI with that of the ‘freehand’ approach by an experienced surgeon for drilling the medial and lateral femoral tunnels while adhering to the recommended angulations for multi-ligament knee injuries.
Ten cadaveric knees underwent computerized tomography (CT) scans to identify anatomical femoral attachments of the lateral collateral ligament (LCL), popliteal tendon (PT), medial collateral ligament (MCL) and posterior oblique ligament (POL). Using Materialise Mimics Medical v25.0 software, virtual planning of a bone tunnel for each ligament was performed, and a total of four tunnels per knee were obtained. Ten PSIs were designed for five knees: five for the medial side and five for the lateral side. The first five knees were operated on via PSI, and the other five knees were operated on by an experienced surgeon using freehand drilling based on preoperative plans. The angular deviation and entry point were assessed by overlaying post-operative CT images onto preoperative CT images.
In the freehand group, the median angular deviation was 22.3°, with an interquartile range (IQR) of 17.6–25.2°. The PSI group presented a significantly greater accuracy in angular deviation for femoral tunnels of 5.7°, with an IQR of 4–8.2° (p < 0.001). Compared with that in the preoperative planning group, the median entry point distance in the freehand group was 5.5 mm, with an IQR of 2.6–8.8 mm. The PSI group had a median entry point distance of 4.2 mm, with an IQR of 3.6–5.7 mm (p = n.s).
Compared with the freehand technique performed by an experienced surgeon, PSI demonstrated significantly greater accuracy in terms of the mean angular deviation.
Level V.
In rotator cuff tears, scapular dyskinesis is often observed. The aim of our study is to better understand the cause and the role of scapular dyskinesis in rotator cuff tears and evaluate changes in scapulothoracic kinematics after Lidocaine subacromial injection and surgery in patients with medium-sized (1–3 cm) rotator cuff tear.
The scapular motion during humerus sagittal flexion of nine healthy persons (healthy group, HG) and nine persons with a medium-sized rotator cuff tear (surgery group, SG) was investigated using the VICON motion capture system and upper limb evaluation in movement analysis software. In addition, quality of life and functional outcomes were assessed in the SG group using American Shoulder and Elbow Surgeons, Oxford and Constant-Murley scores and rotator muscle force and Visual Analogue Scale score were evaluated. The SG was further divided into three subgroups: measurements were performed preoperatively (before surgery native subgroup—BSN), then after subacromial Lidocaine injection (before surgery injection subgroup—BSI) and 6 months after rotator cuff reconstruction (after surgery subgroup—AS). Changes observed after injection (BSI) and surgery (AS) were compared to the BSN.
In the BSI, a significant reduction (p < .025) in protraction was observed in the raising phase between 20° and 70° comparing it to the BSN, protraction decreased by 5.3° ± 7.9° (mean ± standard deviation [SD]). In the lowering phase between 80° and 30°, we registered a decrease of protraction by 6.0° ± 8.3° (mean ± SD). In the AS, we observed an approximation of protraction to the HG, but no significant change was detected.
Significant reduction in scapular protraction was demonstrated with Lidocaine subacromial injection during both the arm raising and lowering phases. Six months of rehabilitation treatment in the postoperative period is not enough to fully eliminate scapular dyskinesis.
Level II.
This study aimed to compare the use of cortisone (C), intra-articular injected at the end of hip arthroscopy in patients with femoroacetabular impingement (FAI), to a new Class III medical device based on hydrolyzed collagen peptides ‘PEPTYS’ (P) and, to investigate potential associations among preoperative symptoms and hip function, outcomes after arthroscopic surgery and presence of inflammatory biomarkers in synovial fluids (SFs) at basal condition.
The two treatments were administrated to patients scheduled for arthroscopy with simple blind randomization sampling. Based on the sample size calculation, the number necessary to recruit was at least 20 patients for the C group and 20 for the P group. SFs, when available, were obtained by aspiration just prior to surgical intervention. At the baseline, osteoarthritis (OA) severity was assessed with a radiographic scoring system (Tönnis classification). Physical examination and clinical assessment using the Hip disability and Osteoarthritis Outcome Score (HOOS) and visual analogue scale (VAS) score for pain were performed at the time of surgery and at 1 and 6 months of follow-up. At the time of surgery, chondral (Outerbridge score) and labral pathology based on direct arthroscopic visualization were also evaluated.
Forty-seven FAI patients were enroled, with a median age of 35 years with a standard deviation (SD) of 10.6 and a body mass index of 24.3kg/m² with an SD of 4.5. 24 patients were treated with C and 23 with P. Both treatments did not show any statistically significant difference in hip function and pain. High expression of inflammatory molecules in SFs was correlated with the worst post-operative articular function.
Our study showed that the use of P was completely comparable to cortisone. Therefore, PEPTYS might be a valuable candidate to improve early recovery, in terms of pain and function, from arthroscopic FAI treatment.
Level III, comparative and randomized study.
To identify genes and patient factors that are related to the development of arthrofibrosis in patients after anterior cruciate ligament (ACL) reconstruction and to develop a prognostic model.
The study included patients diagnosed with ACL injury who underwent ACL reconstruction. Patients were enroled consecutively and divided into non-fibrotic (controls) and fibrotic (cases) groups until a balanced sample of matched case–control was achieved. Arthrofibrosis was considered pathological if the range of motion achieved 3 months after surgery decreased by at least 25% compared to its initial full range of motion. Patient variables and saliva samples were collected from each patient to perform a genetic approach by screening a set of candidate genes implicated in arthrofibrosis. Chi-squared was used to analyze the association between the development of arthrofibrosis and different independent variables. Binary logistic regression was used to develop a prognostic algorithm.
A total of 45 controls (non-fibrotic patients) (50.1%) and 44 cases (fibrotic patients) (49.9%) were included for analysis. The median age was 34.0 years (95% confidence interval = 29.0–38.0) and the number of women was 32 (35.9%). Seven genetic polymorphisms showed significant association with the development of arthrofibrosis (p < 0.05). After binary regression analysis, the regression model included the polymorphisms rs4343 (ACE), rs1800947 (CRP), rs8032158 (NEDD4) and rs679620 (MMP3). This analysis also indicated that female gender was a risk factor while the use of platelet-rich plasma (PRP) during surgery was a preventive factor (p < 0.05).
Genetic alterations involved in inflammation and extracellular matrix turnover predispose to the development of arthrofibrosis after ACL reconstruction. Female sex was a risk factor in the development of this condition, while the application of PRP provided a preventive effect. The combination of patient and genetic variants of a patient allows the development of a prognostic algorithm for the risk of post-surgical arthrofibrosis.
level III.
Primary anterior cruciate ligament (ACL) reconstruction graft failure remains a significant health concern in young patients. Despite the high incidence of poor graft integration in these patients and the resulting high failure rate, little consideration has been given to the quality of the bone into which the graft is anchored at reconstruction. Therefore, we investigated post ACL injury mineralized tissue changes in the ACL femoral entheses of young males and compared them to changes previously reported for young females.
ACL femoral entheses and adjacent bone specimens were harvested from the injured knees of 51 young males during primary ACL reconstructive surgery and from 10 non-injured male cadaveric donors. The specimens were imaged via nano-computed tomography and analyzed for volumetric bone mineral density (vBMD) and architectural changes.
Male femoral ACL explant specimens had significantly lower cortical vBMD (p < 0.001), lower relative bone volume (BV/TV, p = 0.027) and greater cortical bone porosity (Ct.Po, p = 0.027) but similar trabecular bone parameters (p's > 0.05) to those of control specimens from male cadaveric donors. Cortical and trabecular bone loss increased significantly with time from ACL injury to reconstructive surgery (p's < 0.05). While cortical loss occurred in both males and females, significant trabecular loss occurred only in females (p = 0.009).
Femoral entheseal bone loss occurs in males following ACL injury. This bone loss increases with time following ACL injury, with cortical bone loss occurring sooner after injury than trabecular bone loss. The effects of ACL injury and time from injury to surgery on trabecular bone microarchitecture differed between male and female patients.
N/A.
Robotic-assisted total knee arthroplasty (RA-TKA) has gained popularity for its potential ability to improve surgical precision and patient outcomes, despite concerns about its long learning curve and increased operative times. The aim of this study is to evaluate the learning curve of the ROSA® Knee System, the relationship between each phase of the learning curve and the accuracy of the robotic system in femoral component size and knee alignment prediction.
A single surgeon retrospective analysis of total operative time (TOT) and total robotic time was conducted. The first 60 cases of RA-TKA performed between July 2023 and March 2024 were included. Six (10%) patients were excluded due to incomplete surgical reports. A cumulative sum analysis was used to identify the learning and proficiency phases of the surgeon's learning curve. Moreover, femoral component size prediction accuracy and the difference between planned and achieved knee alignment were analyzed.
The projected learning curve showed a significant reduction in TOT after 10 cases, with mean time decreasing from 62.6 ± 7.92 min in the learning phase to 49.9 ± 8.10 min in the proficiency phase (p = 0.0008). The robotic procedure accounted for 48% and 42% of the TOT in the learning and proficiency phases, respectively. Prediction in femoral component size was accurate in 92.6% of cases. The difference between planned and achieved knee alignment was not statistically significant (1.1° ± 0.9°).
The ROSA® Knee System allows a rapid learning curve in RA-TKA, with a significant reduction in operative time after the first 10 cases. An experienced orthopaedic surgeon specialized in knee arthroplasty can quickly reach a proficiency phase, maintaining high accuracy in alignment and femoral component sizing. These findings suggest that the ROSA® system is an effective and reliable tool for CR RA-TKA, offering precise and reproducible outcomes.
IV.
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