Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial.

BACKGROUND: Lesions of the articular cartilage, with or without involvement of the subchondral bone, are a common cause of pain and dysfunction in the knee. Although several treatment options have been developed, the majority of previous clinical trials examined patients with isolated or focal midsized defects, which rarely represent the condition found in the general population. Rather, cartilage lesions are often associated with the presence of mild to moderate osteoarthritic changes. PURPOSE: The present multicenter randomized controlled trial compared the clinical and radiographic outcomes of an aragonite-based osteochondral implant with a control group (arthroscopic debridement/microfractures) in patients affected by joint surface lesions of the knee, including those with concurrent mild to moderate osteoarthritis. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 251 patients were enrolled in 26 medical centers according to the following criteria: age 21 to 75 years, up to 3 cartilage defects of International Cartilage Regeneration & Joint Preservation Society grade 3a or above located on the femoral condyles and/or trochlea, total treatable area from 1 to 7 cm2, bony defect depth ≤8 mm, and knee osteoarthritis grade 0 to 3 according to Kellgren-Lawrence score. Patients were randomized to the aragonite-based implant or debridement/microfracture control arm in a 2:1 ratio. Evaluation was performed at 6, 12, 18, and 24 months based on overall Knee injury and Osteoarthritis Outcome Score (KOOS) as the primary endpoint, and the KOOS subscales (Pain, Quality of Life, Activities of Daily Living), percentage of responders, and International Knee Documentation Committee (IKDC) subjective score as the secondary endpoints. Patients also underwent magnetic resonance imaging evaluation at 12 and 24 months to assess defect fill grade. Failures (ie, need for any secondary treatment) and adverse events were also recorded. RESULTS: The implant group showed a statistically superior outcome in the primary endpoint and all secondary endpoints at each follow-up. The magnitude of improvement in the implant group was twice as large as that in the control group in terms of mean KOOS improvement at 2 years. Responder rate (defined as at least a 30-point improvement in overall KOOS) was 77.8% in the implant group as opposed to 33.6% in the control (P < .0001). Statistically superior results were seen in the IKDC score as well. At 24 months, 88.5% of the implanted group had at least 75% defect fill on magnetic resonance imaging as compared with 30.9% of controls (P < .0001). The failure rate was 7.2% for the implant group versus 21.4% for control. CONCLUSION: This aragonite-based scaffold was safe and effective in the treatment of chondral and osteochondral lesions in the knee, including patients with mild to moderate osteoarthritis, and provided superior outcomes as compared with the control group. REGISTRATION: NCT03299959 (ClinicalTrials.gov identifier).

Orthopedic surgery approach with uncemented metallic prosthesis in knee osteoarthritis increases the quality of life of young patients.

Osteoarthritis is mainly located in the knee area. It is an important concern related to the population health, determined by the influence on the quality of life of patients. Total knee arthroplasty (TKA) with uncemented fixation is among the most encountered procedures performed in patients of a younger age. The present study investigated the response of patients (quality of life, mobility and pain management) with titanium/hydroxyapatite-coated implants with polyethylene inserts. A total of 57 patients with knee arthroplasty were studied with an average age of 54.1±4.9 years and 57.8% were females. The present study focused on the following aspects: The components of such a prosthesis and the way they contribute to a physiological fixation/recovery; how the implant surgery is performed; the clinical and demographic characteristics of the patients; postoperative pain assessment in different types of movement; the management of the movement capacity 1 year after the surgery; and complications that may occur. One year after the surgery, these patients reported pain release, considerably favorable results in every-day activities, and good mobility (capable of using the car, rising from the bed or standing). Knowledge and accurate observation of the correct steps in performing this surgery and the role of the components of the prosthesis can lead to favorable therapeutic outcomes for patients with knee osteoarthritis.

Aragonite-Based Scaffold for the Treatment of Joint Surface Lesions in Mild to Moderate Osteoarthritic Knees: Results of a 2-Year Multicenter Prospective Study.

BACKGROUND: Osteoarthritis (OA) is considered a contraindication to most cartilage repair techniques. Several regenerative approaches have been attempted with the aim of delaying or preventing joint replacement, with controversial results. Currently, there is a paucity of data on the use of single-step techniques, such as cell-free biomimetic scaffolds, for the treatment of joint surface lesions (JSLs) in OA knees. PURPOSE: To present the 2-year follow-up clinical and radiological outcomes after implantation of a novel, cell-free aragonite-based scaffold for the treatment of JSLs in patients with mild to moderate knee OA in a multicenter prospective study. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A total of 86 patients, 60 male and 26 female, with a mean age of 37.4 ± 10.0 years, mild to moderate knee OA, and a mean defect size of 3.0 ± 1.7 cm2, were recruited at 8 medical centers according to the following criteria: radiographic mild to moderate knee OA (Kellgren-Lawrence grade 2 or 3); up to 3 treatable chondral/osteochondral defects (International Cartilage Repair Society grades 3 and 4) on the femoral condyles or trochlea; a total defect size ≤7 cm2; and no concurrent knee instability, severe axial malalignment, or systemic arthropathy. All patients were evaluated at baseline and at 6, 12, 18, and 24 months after implantation using the Knee injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) subjective score. Additionally, magnetic resonance imaging (MRI) was performed to assess the amount of cartilage defect filling at the repaired site. RESULTS: Significant improvement on all KOOS subscales was recorded from baseline (Pain: 49.6 ± 13.1; Activities of Daily Living [ADL]: 56.1 ± 18.4; Sport: 22.8 ± 18.8; Quality of Life [QoL]: 23.5 ± 16.5; Symptoms: 55.4 ± 19.9) to the 24 months' follow-up (Pain: 79.5 ± 21.1 [P < .001]; ADL: 84.1 ± 21.4 [P < .001]; Sport: 60.8 ± 31.9 [P < .001]; QoL: 54.9 ± 30.4 [P < .001]; Symptoms: 77.7 ± 21.2 [P < .001]). The IKDC subjective score showed a similar trend and improved from 37.8 ± 14.7 at baseline to 65.8 ± 23.5 at 24 months (P < .001). MRI showed a significant increase in defect filling over time: up to 78.7% ± 25.3% of surface coverage after 24 months. Treatment failure requiring revision surgery occurred in 8 patients (9.3%). CONCLUSION: The use of an aragonite-based osteochondral scaffold in patients with JSLs and mild to moderate knee OA provided significant clinical improvement at the 24-month follow-up, as reported by the patients. These findings were associated with good cartilage defect filling, as observed on MRI.

Cross-cultural adaptation and validation of the Romanian knee disability and osteoarthritis outcome score for joint replacement (KOOSJR).

AIM: To perform validation of the Romanian Knee disability and Osteoarthritis Outcome Score for Joint Replacement (KOOSJR). METHOD: Ninety-six patients (101 knees) with advanced osteoarthritis (OA) scheduled for total knee replacement completed Romanian translations of KOOSJR and IKDC (International Knee Documentation Committee - subjective knee form) and Euroqol EQ-5D-5 L, and the treating physician completed the original knee society score (KSS). RESULTS: Average age was 66.4 (range 50-83) years and male to female ratio 1:3.76. There was moderate correlation between the test-retest (average 4 days) KOOSJR (r = 0.618, n = 45) and IKDC (r = - 0.671, n = 99), weak between KOOSJR and EQ-5D-5 L Index (r = - 0.431, n = 100) and VAS (r = - 0.364, n = 99) and very weak to KSS score (r = - 0.133, n = 98) and function (r = - 0.072, n = 97) For the first KOOSJR, Cronbach's alpha was 0.816 and intraclass correlation coefficient (ICC) 0.816 (95% CI 0.755-0.866) for average measures. For the retest, Cronbach's alpha was 0.841 (95% CI 0.760-0.903) for averages. CONCLUSION: The Romanian Knee disability and Osteoarthritis Outcome Score for Joint Replacement (KOOSJR) is a valid, reliable, consistent and reproducible clinical score for patients with OA requiring arthroplasty.

Cross-cultural adaptation and validation of the Romanian International Knee Documentation Committee-subjective knee form.

AIM: We aimed to translate and cross-culturally adapt the International Knee Documentation Committee-subjective knee form (IKDC) in Romanian. METHOD: The original (US) IKDC-subjective knee form was translated according to recommended guidelines. Validity was tested using Spearmans's correlation coefficient between score sand test-retest reproducibility. Reliability and internal consistency were determined using Cronbach's alpha coefficient and intraclass correlation coefficient (ICC). RESULTS: A total of 106 data sets were available for processing. The average age was 52 years and the male to female ratio was 40:66. Fifty-five subjects repeated the form after an average of 4 days. There were no floor or ceiling effects (range 3.4-74.7). There was a strong correlation between the first and repeated administration of the IKDC-subjective knee form (r = 0.816, n = 50) and moderate compared to Tegner-Lysholm knee rating scale (r = 0.506, n = 102), KOOSJR (Knee disability and Osteoarthritis Outcome Score for Joint Replacement, r =  - 0.622, n = 96), EuroqolEQ-5D-5L Index (r = 0.633, n = 100) and visual analogue scale VAS (r = 0.484, n = 99). Internal consistency was moderate with Cronbach's alpha 0.611 (n = 102) and ICC 0.611 for average measures (95% CI 0.493-0.713). CONCLUSION: The Romanian translation of the IKDC-subjective knee form is a valid, consistent and reproducible outcome measure in patients with knee pain and dysfunction.

Correlation between multifidus fatty atrophy and lumbar disc degeneration in low back pain.

BACKGROUND: Chronic low back pain (LBP) is common and associated with lumbar disc herniation. The purpose of this study was to investigate if the grade of lumbar disc degeneration correlates with the degree of lumbar multifidus muscle (LMM) fatty atrophy. METHODS: A retrospective analysis on 16 males and 19 females with chronic LBP and a mean age of 47.2 years. Using MRI, the grade of lumbar intervertebral discs degeneration was assessed according to the Pfirrmann classification at L4/L5 and L5/S1 levels. Fatty infiltration of the LMM was graded as normal, mild, moderate and severe. Adobe Photoshop CS6 was used for qualitative image analysis by measuring the Cross-sectional area (CSA) of the pure fat component of LMM. RESULTS: There was a low correlation (R = 0.37) and significant association (ANOVA, p = 0.001, 95% CI 2.07-8.14) between the grade of lumbar disc degeneration and the degree of LMM fatty atrophy. Mean value of intervertebral disc degeneration was 2.9 for the L4/L5 level and 3.2 for L5/S1 respectively. The percentage of fat infiltration of the LMM at both studied levels showed a mean value of 22.91+/- 13.19% for L4/L5 and a higher mean value of 26.37+/- 12.89% for L5/S1. There were higher fatty atrophy scores in women and more disc degeneration in men. CONCLUSION: The percentage of LMM atrophy is higher in the lower levels (L5/S1) and shows a low correlation with the grade of disc degeneration.

Polyglycolic acid-hyaluronan scaffolds loaded with bone marrow-derived mesenchymal stem cells show chondrogenic differentiation in vitro and cartilage repair in the rabbit model.

In cartilage repair, scaffold-assisted one-step approaches are used to improve the microfracture (Mfx) technique. Since the number of progenitors in Mfx is low and may further decrease with age, aim of our study was to analyze the chondrogenic potential of freeze-dried polyglycolic acid-hyaluronan (PGA-HA) implants preloaded with mesenchymal stem cells (MSCs) in vitro and in a rabbit articular cartilage defect model. Human bone marrow-derived MSC from iliac crest were cultured in freeze-dried PGA-HA implants for chondrogenic differentiation. In a pilot study, implants were loaded with autologous rabbit MSC and used to cover 5 mm × 6 mm full-thickness femoral articular cartilage defects (n = 4). Untreated defects (n = 3) served as controls. Gene expression analysis and histology showed induction of typical chondrogenic marker genes like type II collagen and formation of hyaline-like cartilaginous tissue in MSC-laden PGA-HA implants. Histological evaluation of rabbit repair tissue formation after 30 and 45 days showed formation of repair tissue, rich in chondrocytic cells and of a hyaline-like appearance. Controls showed no articular resurfacing, tissue repair in the subchondral zone and fibrin formation. These results suggest that MSC-laden PGA-HA scaffolds have chondrogenic potential and are a promising option for stem cell-mediated cartilage regeneration.

Our experience with orthopedic surgery in hemophiliacs.

INTRODUCTION: Patients having severe hemophilia (levels of deficient factor below 1%) frequently suffer from disabling chronic arthropathy. An adequate substitution treatment using the coagulation factor VIII or IX concentrates renders an elective surgery feasible. OBJECTIVE: The objective of the study was to check the results of different surgical procedures in the treatment of hemophilic arthropathies, and to propose the best protocol of their treatment. METHODS: This is a retrospective study on 26 hemophilic patients operated in the Orthopedics and Trauma Clinic II, Timisoara, from 2002 to 2005. Elective surgical procedures were mainly performed in the knee (21 arthroscopic procedures, 1 open arthrodesis), elbow (2 open synovectomies, 2 radial head excisions), ankle (1 arthroscopic synovectomy and debridement) and thigh (1 giant pseudo tumor excision, other minor procedures). The results after operations on moderate and severe chronic knee, elbow and ankle arthropathy were evaluated, with approximately 24-month follow-up period. RESULTS: Arthroscopic procedures (22) yielded good and satisfactory results with significant improvement according to the evaluation criteria recommended by the World Hemophilia Federation (Gilbert clinical score, Pettersson radiological score, Nuss MRI score). CONCLUSION: Mini-invasive elective surgery in moderate to severe chronic arthropathy produces good results when performed in a specialized centre and with multi-disciplinary approach.