Autologous micro-fragmented adipose tissue injection provides significant and prolonged clinical improvement in patients with knee osteoarthritis: a case-series study.

PURPOSE: Among the conservative strategies to manage patients with symptomatic knee osteoarthritis (OA), an innovative approach exploiting the regenerative capability of adipose tissue and its resident MSCs (Mesenchymal Stem Cells or Medicinal Signalling Cells) has been proposed with encouraging results. This study aims to demonstrate the benefits of autologous micro-fragmented adipose tissue (MAT) injection in the conservative treatment of knee osteoarthritis and whether any variables may affect the outcome. This is a case series single-centre study in which patients underwent intraarticular MAT injection without any associated procedures. METHODS: Based on inclusion and exclusion criteria, 49 patients (67 Knees) were included and retrospectively analysed with a mean follow-up of 34.04 ± 13.62 months (minimum 11 - maximum 59). Patients were assessed through the WOMAC and KOOS questionnaires at baseline (pre-treatment) and 1-, 3-, 6-, 12-, 24- and 36-month follow-up. A minimal clinically important difference (MCID) of at least 7.5 points for the WOMAC pain scale and 7.2 for the WOMAC function scale compared to the baseline value was used. RESULTS: WOMAC and KOOS scores improved after treatment compared to baseline at all follow-ups with p < 0.001. Male gender and Kellgren-Lawrence (KL) grade 2 were associated with smaller improvement in WOMAC and KOOS scores (with respect to females and to KL grade 1, respectively) up to 24 months. The percentage of patients who reach the MCID for WOMAC pain is generally lower than that of patients who reach the MCID for WOMAC function (around 80% at all time points), but it increases significantly over time. Moreover, the baseline score of the WOMAC pain and function influence the outcome. Patients with worse symptoms are more likely to reach the MCID. CONCLUSIONS: Intra-articular knee injection of MAT for the treatment of knee osteoarthritis (KOA), recalcitrant to traditional conservative treatments, proved to be effective in a high percentage of cases. The positive association between a worse pre-operative score and a better clinical response to the treatment would support the idea that intra-articular administration of MAT could be considered in patients with very symptomatic KOA in which joint-replacement surgeries are not indicated (or accepted). LEVEL OF EVIDENCE: IV, case series.

Restricted kinematic alignment is clinically non-inferior to mechanical alignment in the short and mid-term: A systematic review.

BACKGROUND: In recent years, kinematic alignment (KA) is becoming a valid alternative to mechanical alignment (MA) in total knee arthroplasty (TKA). However, to avoid early failures, the restricted kinematic alignment (rKA) approach has been developed to restore native knee kinematics without reproducing extreme knee phenotype. This systematic review aims to evaluate clinical and radiological outcomes between rKA and MA for TKA. METHODS: A systematic literature search was conducted following PRISMA guidelines on Pubmed, Scopus and Cochrane Library. The following search string was adopted: (((restricted kinematic) AND (mechanical)) AND (alignment)) AND (knee). We included studies that analyzed rKA versus MA in terms of clinical outcomes and complications with a minimum of 6 months of follow up. The following rKA- and MA-related data were evaluated: patient-reported outcome scores (PROMs), radiographic analysis of lower limb alignment, and complications. Criteria from the Methodological Index for Non-Randomized Studies were used to assess the methodological quality of the articles. RESULTS: This systematic review included seven clinical studies with a total of 892 knees (471 for MA group and 421 for rKA group, respectively). Overall, post-operative PROMs were similar between rKA and MA. Moreover, rKA reached better results regarding Forgotten Joint Score and post-operative patient satisfaction. Finally, no higher complication rate was observed with the rKA approach. CONCLUSION: The rKA aims to restore native knee kinematics, avoiding extreme deformities. Clinical outcomes are not inferior or even better for rKA compared with MA, without increasing the risk of short-middle-term implant failure. However, there is a high heterogeneity regarding the 'restricted' protocols used.

Management of anterior cruciate ligament revision in adults: the 2022 ESSKA consensus part III-indications for different clinical scenarios using the RAND/UCLA appropriateness method.

PURPOSE: The aim of the ESSKA 2022 consensus Part III was to develop patient-focused, contemporary, evidence-based, guidelines on the indications for revision anterior cruciate ligament surgery (ACLRev). METHODS: The RAND/UCLA Appropriateness Method (RAM) was used to provide recommendations on the appropriateness of surgical treatment versus conservative treatment in different clinical scenarios based on current scientific evidence in conjunction with expert opinion. A core panel defined the clinical scenarios with a moderator and then guided a panel of 17 voting experts through the RAM tasks. Through a two-step voting process, the panel established a consensus as to the appropriateness of ACLRev for each scenario based on a nine-point Likert scale (in which a score in the range 1-3 was considered 'inappropriate', 4-6 'uncertain', and 7-9 'appropriate'). RESULTS: The criteria used to define the scenarios were: age (18-35 years vs 36-50 years vs 51-60 years), sports activity and expectation (Tegner 0-3 vs 4-6 vs 7-10), instability symptoms (yes vs no), meniscus status (functional vs repairable vs non-functional meniscus), and osteoarthritis (OA) (Kellgren-Lawrence [KL] grade 0-I-II vs grade III). Based on these variables, a set of 108 clinical scenarios was developed. ACLRev was considered appropriate in 58%, inappropriate in 12% (meaning conservative treatment is indicated), and uncertain in 30%. Experts considered ACLRev appropriate for patients with instability symptoms, aged ≤ 50 years, regardless of sports activity level, meniscus status, and OA grade. Results were much more controversial in patients without instability symptoms, while higher inappropriateness was related to scenarios with older age (51-60 years), low sporting expectation, non-functional meniscus, and knee OA (KL III). CONCLUSION: This expert consensus establishes guidelines as to the appropriateness of ACLRev based on defined criteria and provides a useful reference for clinical practice in determining treatment indications. LEVEL OF EVIDENCE: II.

Outcomes and complications of inlay versus onlay patellofemoral arthroplasty: A systematic review.

PURPOSE: The purpose of this systematic review was to evaluate outcomes and complications rates between inlay and onlay patellofemoral arthroplasty (PFA). METHODS: According to the PRISMA statement, 42 studies with 2552 patients were included. Data considered for quantitative analysis consisted of the Knee Society Score (KSS), the range of motion (ROM), the visual analogue score (VAS), and the Western Ontario and McMaster Universities questionnaire (WOMAC). Complications and revision surgery were considered. RESULTS: Data on postoperative KSS showed no differences between the groups. The ROM was evaluated in 8 studies for 70 and 331 inlay and onlay PFA, respectively. Onlay group was favorable in terms of postoperative ROM. Postoperative VAS was available for 64 inlay and 110 onlay and no differences were found. Data on postoperative WOMAC were available for 49 inlay and 527 onlay PFA and inlay group showed better scores. A statistically significant higher rate of instability, persistent pain, malposition, stiffness, deep infection, disease progression, and wear of the patellar component were noted in the inlay group. A higher rate of lateral release was noted in the onlay group. A higher number of manipulations under anesthesia was noted in the inlay group. The revision to total knee arthroplasty was reported more frequently in the inlay group. CONCLUSION: A higher rate of conversion to total knee arthroplasty and complication rates after inlay technique was found. The potential of achieving better WOMAC scores with the inlay technique should be weighed against the higher complication and revision rates compared to the onlay technique. LEVEL OF EVIDENCE: IV.

Protocol and descriptive epidemiology of the SIGASCOT Italian multicentric registry of revision ACL reconstruction: a 1-year pilot study.

The aim of the present study was to present the demographic and baseline results of the first year of course of the SIGASCOT Italian registry of Revision ACL reconstruction.The data of the patients undergoing revision ACL reconstruction, enrolled in by 20 SIGASCOT members from March 2015 to May 2016, were extracted from the Surgical Outcome System (SOS). Overall, 126 patients were enrolled; 18 were excluded due to incomplete data. Mean age at surgery was 30.4 ± 9.3 years (median 29; 23-38), mean BMI was 22.6 ± 2.3 kg/m2 and 77% were males. Revision was performed with a single-bundle technique in 94%, using allograft in 57% of cases and autograft in 43%. Only 28% had both menisci intact, and meniscal repair or replacement was performed in 25% of patients for medial meniscus and 8% for lateral meniscus. During the first year of enrollment, the SIGASCOT Italian ACL revision registry was able to collect the data of more than 100 patients. The revision ACL reconstruction was usually performed with a single-bundle technique, using allograft and autograft almost in the same extent.

Italian consensus statement for the use of allografts in ACL reconstructive surgery.

PURPOSE: Graft choice for primary anterior cruciate ligament reconstruction (ACL-R) is debated, with considerable controversy and variability among surgeons. Autograft tendons are actually the most used grafts for primary surgery; however, allografts have been used in greater frequency for both primary and revision ACL surgery over the past decade. Given the great debate on the use of allografts in ACL-R, the "Allografts for Anterior Cruciate Ligament Reconstruction" consensus statement was developed among orthopedic surgeons and members of SIGASCOT (Società Italiana del Ginocchio, Artroscopia, Sport, Cartilagine, Tecnologie Ortopediche), with extensive experience in ACL-R, to investigate their habits in the use of allograft in different clinical situations. The results of this consensus statement will serve as benchmark information for future research and will help surgeons to facilitate the clinical decision making. METHODS: In March 2017, a formal consensus process was developed using a modified Delphi technique method, involving a steering group (9 participants), a rating group (28 participants) and a peer-review group (31 participants). Nine statements were generated and then debated during a SIGASCOT consensus meeting. A manuscript has been then developed to report methodology and results of the consensus process and finally approved by all steering group members. RESULTS: A different level of consensus has been reached among the topics selected. Strong agreement has been reported in considering harvesting, treatment and conservation methods relevant for clinical results, and in considering biological integration longer in allograft compared to autograft. Relative agreement has been reported in using allograft as the first-line graft for revision ACL-R, in considering biological integration a crucial aspect for rehabilitation protocol set-up, and in recommending a delayed return to sport when using allograft. Relative disagreement has been reported in using allograft as the first-line graft for primary ACL-R in patients over 50, and in not considering clinical results of allograft superior to autograft. Strong disagreement has been reported in using allograft as the first-line graft for primary ACL-R and for skeletally immature patients. CONCLUSIONS: Results of this consensus do not represent a guideline for surgeons, but could be used as starting point for an international discussion on use of allografts in ACL-R. LEVEL OF EVIDENCE: IV, consensus of experts.

Use of a Biomimetic Scaffold for the Treatment of Osteochondral Lesions in Early Osteoarthritis.

The aim of this study is to investigate clinical and radiographic outcomes of a biomimetic scaffold for the treatment of osteochondral knee lesions in patients with early OA. Study population was represented by 26 patients with a mean age of 44 years affected by early OA. Inclusion criteria were two episodes of knee pain for more than 10 days in the last year, Kellgren-Lawrence OA grade 0 or I or II, and arthroscopic findings of cartilage defects. Nineteen patients had a previous surgery, 11 of which were revision surgeries of osteochondral unit. All patients were treated with a biomimetic scaffold with a tri-layered structure of type I equine collagen and magnesium-enriched hydroxyapatite. Clinical outcomes were evaluated using the IKDC, Lysholm, VAS, KOOS, and Tegner scores at baseline and at an average follow-up of 35 months. Magnetic resonance imaging (MRI) was performed at follow-up time in 19 patients. Clinical outcomes showed significant improvement in VAS, Lysholm, IKDC subjective score, and KOOS subscales in 69% of the patients. Complication rate of this cases series was 11%, with no surgical failure, although 31% of patients did not reach a significant improvement and were thus considered as clinical failure. MRI analysis showed integration of the scaffold only in 47% of the patients, with partial regeneration of the subchondral bone. No correlation between clinics and radiological images was found. The use of a biomimetic osteochondral scaffold in the setting of an early OA, alone or associated with other procedures, appeared to be a valid and safe option, able to provide good and stable clinical outcomes with high patient's satisfaction and low complication rate.

Medial vs lateral unicompartmental knee arthrroplasty: clinical results.

Unicompartmental Knee Arthroplasty (UKA) is a common procedure for the management of isolated osteoarthritis. UKA is considered less invasive compared to total knee arthroplasty, associated with less operative time, blood loss and faster recovery. Isolated lateral osteoarthritis is a relatively uncommon clinical problem, with an incidence about ten times lower than the medial compartment. In fact, lateral UKA are about 5-10% of the total amount of the UKAs. In addition, it's historically considered more challenging and with poorer results. The aim of this paper was to compare current indications, modes of failure, survivorship and clinical results of medial and lateral UKA by a narrative review of the latest literature.

Load distribution in early osteoarthritis.

Total knee replacement is an accepted standard of care for the treatment of advanced knee osteoarthritis with good results in the vast majority of older patients. The use in younger and more active populations, however, remains controversial due to concerns over activity restrictions, implant survival, and patient satisfaction with the procedure. It is in these younger patient populations that alternatives to arthroplasty are increasingly being explored. Historically, osteotomy was utilized to address unicompartmental pain from degeneration and overload, for example, after meniscectomy. Utilization rates of osteotomy have fallen in recent years due to the increasing popularity of partial and total knee arthroplasty. This article explores the indications and outcomes of traditional unloading osteotomy, as well as newer options that are less invasive and offer faster return to function.

Prospective multi-centre study on a composite ceramic femoral component in total knee arthroplasty: Five-year clinical and radiological outcomes.

BACKGROUND: Enhanced wear resistance of ceramics in general and improved mechanical characteristics of composite ceramics in terms of strength and resistance meet the demands for application in TKA. The aim of this prospective international multi-centre study was to evaluate the 5-year clinical and radiological outcomes of an unconstrained TKA with a composite ceramic femoral component. METHODS: A total of 107 patients (109 knees) underwent TKA with the MULTIGEN-PLUS Ceramic Knee at seven centres in three European countries. Clinical and radiological assessments were performed preoperatively and postoperatively at 3, 12, 24 and 60 months, using HSS, WOMAC, SF-36 and standardised radiographs. RESULTS: Mean HSS and WOMAC increased significantly from 55.1±11.5 (21-83) and 48.1±16.6 (3-90) preoperatively to 85.6±9.6 (49-98) and 73.3±20.4 (17-100) at 60 months. Mean SF-36 showed significant improvements in patients' quality of life (49.1±17.6 (12-96) preoperatively versus 67.7±23.1 (12-100) at 60 months). Non-progressive radiolucent lines (<1 mm) were observed around the femoral component in four cases. Neither implant migration nor loosening were registered. Kaplan-Meier survivorship was 96.0% at 60 months (92.1-100%, CI 95%). CONCLUSIONS: Five-year implant survival rate of the ceramic knee is comparable to other metallic and ceramic unconstrained TKA systems. Although the assessment of long-term implant survivorship is still pending, the ceramic implants represent a promising solution for patients with allergies against metallic components and furthermore for the general osteoarthritis population due to enhanced wear resistance.

Use of the KineSpring system in the treatment of medial knee osteoarthritis: preliminary results.

PURPOSE: the purpose of this study was to analyze our preliminary results obtained with the KineSpring system in patients suffering from medial compartment knee osteoarthritis (OA). METHODS: between September 2012 and May 2014, 53 patients underwent treatment with the KineSpring system. Patient self-assessment was performed pre-operatively and at 3, 6 and 12 months postoperatively, and included the KOOS, Tegner activity score, Lysholm functional knee score, VAS knee pain score, and IKDC score. Device- and procedure-related adverse events were recorded. RESULTS: mean KOOS subscales, except for the Sport/Recreation subscale at six months, improved over time. Mean WOMAC Pain and Function domains, Lysholm score, IKDC score and VAS knee pain score improved over the follow-up period and were significantly improved at 3, 6 and 12 months postoperatively compared to baseline. Mean Tegner score improved slightly over time. In 5 of the 53 (9.4%) patients re-operation was necessary. In 3 patients the device was removed due to infection (one case) or persistent knee pain (two cases). Surgical arthrolysis was performed in two patients. CONCLUSIONS: in our preliminary experience, the KineSpring system gave good short-term clinical results. LEVEL OF EVIDENCE: Level IV, therapeutic case series.

Combined PCL and PLC reconstruction in chronic posterolateral instability.

PURPOSE: The posterolateral corner (PLC) is more likely to be injured in combination with the posterior cruciate ligament (PCL) or the anterior cruciate ligament than in isolation. This leads to instability of the knee and loss of function. We hypothesised that combined PCL and PLC reconstruction would restore sufficient stability to allow improvement in patient symptoms and function. METHODS: 19 patients who underwent arthroscopic-assisted single-bundle PCL and PLC reconstruction by a single surgeon were analysed retrospectively. The PLC reconstruction was a modified Larson reconstruction of the lateral collateral ligament and the popliteofibular ligament. The IKDC and Tegner scores were used to assess outcome. Dial test and varus laxity were used to assess improvements in clinical laxity. Posterior laxity was tested using the KT-1000. RESULTS: The mean follow-up was 38 months (±(2× standard deviations), ±12.3). There were no postoperative complications. All patients had less than 5 mm posterior step-off. 17 of 19 patients had negative dial and varus stress tests. Measured range of motion was reduced by a mean of 10°, but patients did not report any daily activities restrictions. Tegner scores improved from a median pre-operative value of 2 (range 1-4) to 6 (4-9) at final follow-up. The mean postoperative IKDC score was 86 (±11). CONCLUSIONS: Subjectively, the knee stability achieved allowed daily activities. However, there were remaining abnormalities in range of motion, posterior drawer and rotational laxity, suggesting that normal knee laxity was not restored. LEVEL OF EVIDENCE: IV.

Ceramic femoral components in total knee arthroplasty - two year follow-up results of an international prospective multi-centre study.

BACKGROUND: Total knee arthroplasty can be considered as a reliable surgical procedure with a good long-term clinical result. However, implant failure due to particle induced aseptic loosening as well as the aspect of hypersensitivity to metal ions still remains an emerging issue. METHODS: The purpose of this prospective international multi-centre study was to evaluate the clinical and radiological outcomes and the reliability of the unconstrained Multigen Plus Total Knee System with a new BIOLOX® delta ceramic femoral component. Cemented total knee arthroplasty was performed on 108 patients (110 knees) at seven hospitals in three countries. Clinical and radiological evaluations were performed preoperatively, and after 3, 12 and 24 months postoperatively using the HSS-, WOMAC-, SF-36-score and standardised X-rays. RESULTS: The mean preoperative HSS-Score amounted to 55.5 ± 11.5 points and improved significantly in all postoperative evaluations (85.7 ± 11.7 points at 24 months). Furthermore, improvements in WOMAC- and SF-36-score were evaluated as significant at all points of evaluation. Radiolucent lines around the femoral ceramic component at 24 months were found in four cases. Progression of radiolucent lines was not seen and no implant loosening was observed. During the 24 month follow-up eight patients underwent subsequent surgery due to reasons unrelated to the implant material. CONCLUSIONS: The observed clinical and radiological results are encouraging for a long-term survival of the ceramic femoral component. Therefore, ceramic implants could be a promising solution not only for patients with allergies against metallic implant materials, but also for the osteoarthritic knee joint. Long-term follow-up is necessary to draw conclusions regarding the superiority of the ceramic knee implants concerning in vivo wear and long-term survivorship.

Results of isolated posterolateral corner reconstruction.

BACKGROUND: Isolated posterolateral corner (PLC) tears are relatively rare events. Various surgical techniques to treat posterolateral knee instability have been described; because surgical results are linked to cruciate reconstructions it has been difficult to date to define whether one surgical procedure has better prognosis than another. The goal of this study is to determine the clinical outcome of PLC reconstruction following fibular-based technique. MATERIALS AND METHODS: We retrospectively evaluated a case series of patients who received isolated PLC reconstruction between March 2005 and January 2007. Ten patients were surgically treated for isolated injuries and were available for follow-up; average patient age was 27.4 years (range 16-47 years). All patients were treated following the fibular-based technique: double femoral tunnel was performed in six patients, while in the remaining four patients, the reconstruction of the PLC was performed with a single femoral tunnel. Six patients had semitendinosus allograft and four had semitendinosus autograft. All patients had the same evaluation and the same rehabilitation protocol. RESULTS: Mean follow-up was 27.5 months (range 18-40 months). Mean range of motion (ROM) was 143.5 degrees for flexion (range 135-150 degrees) and 0.5 degrees for extension (range 0-3 degrees). Three patients showed 1+ on varus stress test, while on Dial test another three patients showed 10 degrees reduction of external rotation compared with contralateral knee. The average Lysholm score was 94 points (range 83-100), and the mean International Knee Documentation Committee (IKDC) subjective result was 88.48 (range 74-96.5). Based on Lysholm score, the results were excellent in eight knees and good in two knees. On IKDC evaluation, two patients were grade A and eight were grade B. No significant difference in clinical results was observed between single and double femoral tunnel. CONCLUSION: Fibular-based technique showed good results in terms of clinical outcome, restoring varus and rotation stability of knees in treatment of chronic isolated PLC injury.