An Observational Prospective Clinical Study for the Evaluation of a Collagen-Hydroxyapatite Composite Scaffold in Hip Revision Surgery.

One of the greatest challenges of hip revision surgery is the need to restore extensive bone loss by creating a stable reconstruction with long-term durability. The present observational, investigator-initiated prospective study was carried out to evaluate the clinical and radiological results of the use of a commercial biomimetic collagen-hydroxyapatite composite biomaterial (RegenOss) applied in hip revision surgery. Thirty-three patients who underwent hip revision were included in this study, and 29 received up to 2 years of follow-up. The acetabulum was reconstructed using an uncemented hemispherical shell both with or without an iliac fixation stem. Functional recovery was assessed according to the Harris Hip Score (HHS) at the pre-hospitalisation check-up, and at 6-, 12-, and 24-month follow-ups. Radiological evaluation consisting of X-ray analyses (6, 12, and 24 month follow-ups) and CT scan exams (within 10 weeks post-surgery and at 12-month follow-up) were performed to evaluate the reduction in bone defect and new bone regeneration. All the patients reported a complete recovery and a considerable improvement in functional outcome assessed by the HHS, which was significantly higher at all the follow-ups than at pre-hospitalisation. Moreover, radiological assessments revealed good scaffold integration. Overall, collected data suggest that RegenOss is a valid and safe alternative to restoring acetabular bone loss in revision hip arthroplasty.

Microfragmented Adipose Tissue Versus Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Prospective Randomized Controlled Trial at 2-Year Follow-up.

BACKGROUND: Intra-articular microfragmented adipose tissue (MF-AT) injections have been proposed for the treatment of knee osteoarthritis (OA). PURPOSE: To compare a single injection of MF-AT or platelet-rich plasma (PRP) in terms of clinical outcomes and OA progression. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 118 patients with symptomatic knee OA were randomized to receive a single intra-articular injection of MF-AT or PRP. Patients were evaluated before the injection and at 1, 3, 6, 12, and 24 months with the International Knee Documentation Committee (IKDC) subjective score, Knee injury and Osteoarthritis Outcome Score (KOOS) subscales, EuroQol visual analogue scale (EQ-VAS), EuroQol 5 dimensions (EQ-5D), and visual analogue scale (VAS) for pain. Primary outcomes were the IKDC subjective score and the KOOS pain subscore at 6 months. Knees were evaluated at baseline and at 6, 12, and 24 months with radiography and high-resolution magnetic resonance imaging (MRI) using the Whole-Organ Magnetic Resonance Imaging Score (WORMS). RESULTS: Both MF-AT and PRP provided a statistically and clinically significant improvement up to 24 months. The improvement in the IKDC subjective score from baseline to 6 months was similar in both MF-AT (41.1 ± 16.3 to 57.3 ± 18.8) and PRP (44.8 ± 17.3 to 58.4 ± 18.1) groups (P < .0005). The improvement in the KOOS pain subscore from baseline to 6 months was similar in both the MF-AT (58.4 ± 15.9 to 75.8 ± 17.4) and PRP (63.5 ± 17.8 to 75.5 ± 16.1) groups (P < .0005). Overall, no differences were found between the MF-AT and PRP groups in terms of clinical outcomes, adverse events (18.9% and 10.9%, respectively), and failures (15.1% and 25.5%, respectively). Radiographic and MRI findings did not show changes after the injection. As a secondary outcome, more patients in the MF-AT group with moderate/severe OA reached the minimal clinically important difference for the IKDC score at 6 months compared with the PRP group (75.0% vs 34.6%, respectively; P = .005). CONCLUSION: A single intra-articular injection of MF-AT was not superior to PRP, with comparable low numbers of failures and adverse events and without disease progression. No differences were found in clinical and imaging results between the 2 biological approaches.

Cell-Free Biomimetic Osteochondral Scaffold for the Treatment of Knee Lesions: Clinical and Imaging Results at 10-Year Follow-up.

BACKGROUND: Cell-free devices have been introduced to restore osteochondral defects, avoiding the limitations of cell-based procedures. Among these, an osteochondral scaffold made of type I collagen and hydroxyapatite has been investigated with promising results up to medium-term follow-up. However, the clinical and imaging results over time still need to be documented. PURPOSE: To evaluate the clinical outcome and tissue maturation at long-term follow-up after the implantation of the osteochondral scaffold. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A total of 24 patients (7 women, 17 men; age, 36 ± 9.5 years) underwent surgical implantation of the osteochondral scaffold and were prospectively evaluated before surgery, at 2-, 5-, and 10-year follow-up. The mean defect size was 2.9 ± 1.4 cm2. Patients were evaluated using the International Knee Documentation Committee (IKDC) subjective and objective scores, and the activity level was documented with the Tegner score. Magnetic resonance imaging (MRI) evaluation involved the use of the magnetic resonance observation of cartilage repair tissue score combined with 5 more variables focused on the bone layer. RESULTS: A statistically significant improvement of all clinical scores was documented from the baseline to the final evaluation. The IKDC subjective score improved from the preoperative level to 2 years (41 ± 13.2 and 77.1 ± 14.6, respectively) (P < .0005), with stable results up to 10 years (77.4 ± 19.4). The IKDC objective score changed from 52% of normal and nearly normal knees before the treatment to 84% at 10 years (P < .0005). Tegner sports activity at the final evaluation (3.8 ± 1.7) was higher compared with the preoperative level (1.6 ± 1.1; P < .05), but it remained significantly lower compared with the preinjury level (5.5 ± 2.6; P < .05). Treatment failed in 1 patient. Persisting graft alterations were observed on MRI scans, although without correlating with the clinical outcome. CONCLUSION: The regenerative potential of this scaffold is limited, as demonstrated by the signal alterations persisting over time on MRI scans. On the other hand, the clinical improvement was significant and stable over time both in terms of subjective and objective outcomes, including activity level, with overall good results.

Weight bearing versus conventional CT for the measurement of patellar alignment and stability in patients after surgical treatment for patellar recurrent dislocation.

PURPOSE: To compare weight-bearing cone-beam computer tomography (CBCT) and conventional computer tomography (CT)-based measurements of patellofemoral alignment and stability in patients surgically treated for recurrent patellar dislocation. These scans implied respectively single-leg up-right posture, the knee flexed, and lower limb muscles activation, versus supine position with the knee extended. METHODS: A total of 17 patients (11 males/6 females) after surgical reconstruction with fascia lata allograft for recurrent patellofemoral dislocation were analyzed at 60-month follow-up. Tilt and congruence angles and tibial tuberosity-trochlear groove (TT-TG) offset were measured on images obtained from CBCT and conventional CT scans by three independent and expert radiologists. Paired t tests were performed to compare measurements obtained from the two scans. Inter-rater reliability was assessed using a two-way mixed-effects model intra-class correlation coefficient (ICC). RESULTS: Only TT-TG offset was found significantly smaller (p < 0.001) in CBCT (mean 9.9 ± 5.3 mm) than in conventional CT (mean 15.9 ± 4.9 mm) scans. ICC for tilt and congruence angles and for TT-TG offset ranged between 0.80-0.94 with measurements in CBCT scans, between 0.52 and0.78 in conventional CT. CONCLUSION: In patients surgically treated for recurrent patellar dislocation, TT-TG offset was found overestimated with conventional CT. All measurements of patellofemoral stability and alignment were found more consistent when obtained with weight-bearing CBCT compared to conventional CT.

Autologous chondrocytes versus filtered bone marrow mesenchymal stem/stromal cells for knee cartilage repair-a prospective study.

PURPOSE: To document clinical, radiologic, and cellular data of a prospective patient series treated by a tri-layer collagen-hydroxyapatite biomimetic osteochondral scaffold (CHAS) intra-operatively seeded with cultivated autologous chondrocytes (AC) or with filtered bone marrow stem/stromal cells (fBMSC) to address chronic osteochondral knee lesions. METHODS: Thirty-six consecutive patients (15 to 59 years) with chronic osteochondral lesions (1.8-10 cm2) in the condylar or patellofemoral knee surfaces were enrolled. Lesions were covered with CHAS fixed with a fibrin glue. The superficial layer of CHAS was intra-operatively injected with active cells: in initial five patients, ACs were put directly onto dry CHAS (dry-AC); next, eight AC patients had CHAS moistened with cell culture media (media-AC), while the tourniquet was released allowing blood soaking of CHAS in the rest (14 blood-AC, 9 blood-fBMSC). Seventeen (50%) patients required different concomitant procedures. All patients were followed for serious adverse events (SAE) or graft failures; clinical, radiographic, and MRI evaluation was conducted. Cellular data on the injected cells were assessed. RESULTS: At a follow-up of 39 months (16-81), 17 patients required an additional surgical intervention: seven graft-related SAE (early post-operative synovitis and/or arthrofibrosis) were registered (3 dry-AC, 3 media-AC, 1 blood-fBMSC). There were two graft failures (1 dry-AC, 1 blood-fBMSC) for secondary reasons. All clinical scores significantly improved from pre- to post-operative values: IKCD subjective 44 to 65; IKDC examination (9/17/5/5) to (20/10/5/1); KOOS (P61/S59/ADL67/Sp32/QoL31) to (P79/S75/ADL84/Sp55/QoL51); Tegner activity scale 3.3 to 4.4. There was evidence of radiographic osteoarthritis progression-Kellgren-Lawrence 1.0 to 1.5. MOCART scores at the final follow-up averaged 71 (10 to 95). Graft-type analysis demonstrated an increased rate of graft-related SAE in dry-AC and media-AC, but their final outcomes were equivalent. Cellular data of AC at the implantation were as follows: cells in suspension 9.2 × 106, viability 95%. In blood-fBMSC group, a cell suspension with 87% viability was injected, which contained 1156 CFU-Fs. CONCLUSION: CHAS with intra-operative seeding of active cells, either AC or fBMSC, led to an overall successful outcome for the treatment of chronic osteochondral lesions in the knee. Blood soaking of CHAS in situ before cell seeding significantly decreased early post-operative adverse events, such as synovitis and arthrofibrosis.

Matrix-assisted chondrocyte transplantation with bone grafting for knee osteochondritis dissecans: stable results at 12 years.

PURPOSE: To document clinical and radiological results of arthroscopic matrix-assisted autologous chondrocyte transplantation (MACT) combined with bone grafting for the treatment of knee osteochondritis dissecans (OCD) at long-term follow-up. METHODS: Thirty-one knees in 29 patients (20.4 ± 5.7 years) were treated for symptomatic unfixable OCD lesions (2.6 ± 1.1 cm2) and prospectively evaluated at 2, 5, and 12 years (average, minimum 10 years). Patients were evaluated over time with IKDC subjective score, EQ-VAS, and Tegner scores. Failures were also documented. At the final follow-up, MRI evaluation was performed in 14 knees with the MOCART 2.0 score. RESULTS: Beside 4 early failures, an overall clinical improvement was documented: the IKDC subjective score improved from 39.9 ± 16.8 to 82.1 ± 17.0 and 84.8 ± 17.2 at 2 and 5 years, respectively (p < 0.0005), and remained stable for up to 12 years (85.0 ± 20.2). EQ-VAS and Tegner scores presented similar trends, but patients did not reach their original activity level. Worse results were obtained for lesions bigger than 4 cm2. At MRI evaluation, subchondral bone abnormalities were detected in over 85% of knees at long-term follow-up. CONCLUSIONS: Arthroscopic bone grafting followed by MACT for unfixable knee OCD can offer a promising and stable clinical outcome over time in lesions smaller than 4 cm2, with a low failure rate of 13%. Persistent subchondral alterations were documented at long-term MRI evaluation, suggesting the limits of this approach to regenerate the osteochondral unit in patients affected by knee OCD. LEVEL OF EVIDENCE: IV.

Treatment of Juvenile Knee Osteochondritis Dissecans with a Cell-Free Biomimetic Osteochondral Scaffold: Clinical and MRI Results at Mid-Term Follow-up.

OBJECTIVE: Osteochondral surgical procedures have been described for the treatment of unfixable osteochondritis dissecans (OCD), but only few of them have been studied for juvenile OCD (JOCD) lesions. A cell-free biomimetic osteochondral scaffold showed positive results in adult patients. The aim of this study was to evaluate the results of this scaffold for the treatment of knee JOCD at mid-term follow-up. DESIGN: Twenty patients (14 males, 6 females) were included in this study. Mean age was 16.2 ± 1.4 years, average defect size was 3.2 ± 1.8 cm2, and mean symptoms duration was 20.2 ± 17.9 months. After the implantation of the osteochondral collagen-hydroxyapatite scaffold (Maioregen, Fin-Ceramica, Faenza, Italy), patients were evaluated preoperatively and prospectively at 1, 2, and at final mean follow-up of 6 years (range 5-7 years) with International Knee Documentation Committee (IKDC) subjective and objective, Tegner, and EuroQol visual analogue scale (VAS) scores. MRI evaluation was performed with the MOCART 2.0 score. RESULTS: All scores showed a significant improvement. IKDC subjective score went from 50.3 ± 17.4 preoperative score to 75.3 ± 14.6 at 1 year (P = 0.002), 80.8 ± 14.6 at 2 years and 85.0 ± 9.3 at 6 years. The Tegner score improved from the preoperative evaluation of 2.6 ± 1.4 to 5.5 ± 2.0 at 6 years (P < 0.0005), although without reaching the level registered before the onset of symptoms. A longer symptoms duration influenced negatively IKDC subjective and Tegner scores up to 2 years (P = 0.003 and P = 0.002, respectively) but did not affect the final outcome. Lesion size did not affect the final result. The MOCART 2.0 score showed a significant improvement between 1-year and final follow-up, but with persisting subchondral alterations. CONCLUSIONS: This study demonstrated a clinical improvement stable over time with a high survival rate, although with persisting abnormal MRI findings, especially at subchondral bone level. This procedure can be considered a suitable option for the treatment of young patients affected by knee OCD. Level of evidence. Case series, level IV.

Graft-Preserving Arthroscopic Debridement With Hardware Removal Is Effective for Septic Arthritis After Anterior Cruciate Ligament Reconstruction: A Clinical, Arthrometric, and Magnetic Resonance Imaging Evaluation.

BACKGROUND: Arthroscopic debridement with graft preservation has been advocated as the treatment of choice for septic arthritis after anterior cruciate ligament (ACL) reconstruction, but no previous studies have investigated if hardware removal, while retaining the graft in situ, improves the success rate. Moreover, it is unclear whether the premature removal of fixation devices may affect graft integration and knee stability. PURPOSE/HYPOTHESIS: The purpose was to assess the clinical and functional outcomes of patients with septic arthritis after ACL reconstruction who underwent arthroscopic debridement, while retaining the graft in situ but removing fixation devices, and to determine if premature hardware removal affects graft integrity and function. The hypothesis was that arthroscopic debridement with hardware removal would be effective in eradicating infections while not compromising graft integration and function. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: From a cohort of 2384 cases of arthroscopic ACL reconstruction, 24 patients with postoperative septic arthritis were included for the analysis; 18 patients were available for a clinical evaluation using the International Knee Documentation Committee (IKDC) form, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lysholm score, and Tegner score at a minimum 12-month follow-up. Knee laxity was assessed clinically with standardized manual laxity tests and instrumentally using an arthrometer and a triaxial accelerometer. Additionally, 3-T magnetic resonance imaging (MRI) at final follow-up was performed, focusing on the graft signal, the cartilage status, and the occurrence of arthrofibrosis. RESULTS: Eradication of the infection was achieved in all cases, and only 1 graft removal was performed because of insufficient tension. Among the remaining 23 patients, a single arthroscopic debridement procedure with hardware removal while preserving the graft was effective in 21 cases (91%) at a mean of 30 ± 37 days from ACL reconstruction to debridement. At last follow-up, 2 patients required a further ACL revision procedure. The mean IKDC, WOMAC, Lysholm, and Tegner scores of the patients available for the clinical evaluation were 75 ± 19, 90 ± 8, 79 ± 21, and 6 ± 2, respectively. No abnormal laxity was reported on manual testing, and arthrometric and accelerometer tests also demonstrated good knee stability (mean KT-1000 arthrometer side-to-side difference was 1.6 ± 1.2 mm at manual maximum force). On MRI, a good graft signal was found in 50% of cases, while concomitant signs of arthrofibrosis were detected in 81% of patients. Severe cartilage defects (International Cartilage Repair Society grade ≥3) were reported in 63% of cases. CONCLUSION: Arthroscopic debridement with hardware removal was effective in the eradication of infections after ACL reconstruction with extra-articular fixation while preserving graft integrity without compromising knee stability. Patients and surgeons should be aware of complications that might affect the outcome, particularly arthrofibrosis and chondrolysis.

A multilayer biomaterial for osteochondral regeneration shows superiority vs microfractures for the treatment of osteochondral lesions in a multicentre randomized trial at 2 years.

PURPOSE: The increasing awareness on the role of subchondral bone in the etiopathology of articular surface lesions led to the development of osteochondral scaffolds. While safety and promising results have been suggested, there are no trials proving the real potential of the osteochondral regenerative approach. Aim was to assess the benefit provided by a nanostructured collagen-hydroxyapatite (coll-HA) multilayer scaffold for the treatment of chondral and osteochondral knee lesions. METHODS: In this multicentre randomized controlled clinical trial, 100 patients affected by symptomatic chondral and osteochondral lesions were treated and evaluated for up to 2 years (51 study group and 49 control group). A biomimetic coll-HA scaffold was studied, and bone marrow stimulation (BMS) was used as reference intervention. Primary efficacy measurement was IKDC subjective score at 2 years. Secondary efficacy measurements were: KOOS, IKDC Knee Examination Form, Tegner and VAS Pain scores evaluated at 6, 12 and 24 months. Tissue regeneration was evaluated with MRI MOCART scoring system at 6, 12 and 24 months. An external independent agency was involved to ensure data correctness and objectiveness. RESULTS: A statistically significant improvement of all clinical scores was obtained from basal evaluation to 2-year follow-up in both groups, although no overall statistically significant differences were detected between the two treatments. Conversely, the subgroup of patients affected by deep osteochondral lesions (i.e. Outerbridge grade IV and OCD) showed a statistically significant better IKDC subjective outcome (+12.4 points, p = 0.036) in the coll-HA group. Statistically significant better results were also found for another challenging group: sport active patients (+16.0, p = 0.027). Severe adverse events related to treatment were documented only in three patients in the coll-HA group and in one in the BMS group. The MOCART score showed no statistical difference between the two groups. CONCLUSIONS: This study highlighted the safety and potential of a biomimetic implant. While no statistically significant differences were found compared to BMS for chondral lesions, this procedure can be considered a suitable option for the treatment of osteochondral lesions. LEVEL OF EVIDENCE: I.

Treatment of Knee Osteochondritis Dissecans With a Cell-Free Biomimetic Osteochondral Scaffold: Clinical and Imaging Findings at Midterm Follow-up.

BACKGROUND: Osteochondritis dissecans (OCD) is a developmental condition of subchondral bone that may result in secondary separation and instability of the overlying articular cartilage, which in turn may lead to degeneration of the overall joint and early osteoarthritis. Biphasic scaffolds have been developed to address defects of the entire osteochondral unit by reproducing the different biological and functional requirements and guiding the growth of both bone and cartilage. PURPOSE: To evaluate midterm clinical and imaging results after cell-free osteochondral scaffold implantation for the treatment of knee OCD. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Twenty-seven patients (8 women, 19 men; mean age, 25.5 ± 7.7 years) were treated for knee OCD, with International Cartilage Repair Society (ICRS) grade 3 to 4 lesions with a mean size of 3.4 ± 2.2 cm2 (range, 1.5-12 cm2), and prospectively evaluated for up to 5 years using the ICRS classification system and the Tegner score. Eighteen patients underwent magnetic resonance imaging (MRI) at 24 and 60 months of follow-up, and the graft was evaluated using the magnetic resonance observation of cartilage repair tissue (MOCART) score for the cartilage layer, while a specific score was used for subchondral bone. RESULTS: All patients significantly improved their clinical scores at each follow-up until their final evaluation. The mean International Knee Documentation Committee (IKDC) subjective score improved from 48.4 ± 17.8 to 82.2 ± 12.2 at 2 years ( P < .0005), and it then remained stable for up to 5 years postoperatively (90.1 ± 12.0). The mean Tegner score increased from 2.4 ± 1.7 preoperatively to 4.4 ± 1.6 at 2 years ( P = .001), with a further increase up to 5.0 ± 1.7 at 5 years of follow-up ( P < .0005 vs preoperatively), reaching almost the preinjury level (5.7 ± 2.2). The MOCART score showed stable results between 24 and 60 months, whereas the subchondral bone status significantly improved over time. No correlation was found between MRI findings and clinical outcomes. CONCLUSION: This 1-step cell-free scaffold implantation procedure showed good and stable results for up to 60 months of follow-up for the treatment of knee OCD. MRI showed abnormalities, in particular at the subchondral bone level, but there was an overall improvement of features over time. No correlation was found between imaging and clinical findings.

One-Step Treatment for Patellar Cartilage Defects With a Cell-Free Osteochondral Scaffold: A Prospective Clinical and MRI Evaluation.

BACKGROUND: The treatment of symptomatic cartilage defects of the patella is particularly challenging, and no gold standard is currently available. PURPOSE: To evaluate the clinical results of a biphasic cell-free collagen-hydroxyapatite scaffold and to evaluate osteochondral tissue regeneration with magnetic resonance imaging (MRI). STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Thirty-four patients (18 men and 16 women; mean ± SD: age, 30.0 ± 10 years) were treated by scaffold implantation for knee chondral or osteochondral lesions of the patella (area, 2.1 ± 1 cm2). The clinical evaluation was performed prospectively at 12 and 24 months via the IKDC (International Knee Documentation Committee; objective and subjective) and Tegner scores. MRI evaluation was performed at both follow-ups in 18 lesions through the MOCART score (magnetic resonance observation of cartilage repair tissue) and specific subchondral bone parameters. RESULTS: A statistically significant improvement in all the scores was observed at 12- and 24-month follow-up as compared with the basal evaluation. The IKDC subjective score improved from 39.5 ± 14.5 to 61.9 ± 14.5 at 12 months ( P > .0005) with a further increase to 67.6 ± 17.4 at 24 months of follow-up (12-24 months, P = .020). The MRI evaluation showed a stable value of the MOCART score between 12 and 24 months, with a complete filling of the cartilage in 87.0% of the lesions, complete integration of the graft in 95.7%, and intact repair tissue surface in 69.6% at final follow-up. The presence of osteophytes or more extensive bony overgrowth was documented in 47.8% of the patients of this series, but no correlation was found between MRI findings and clinical outcome. CONCLUSION: The implantation of a cell-free collagen-hydroxyapatite osteochondral scaffold provided a clinical improvement at short-term follow-up for the treatment of patellar cartilage defects. Women had lower outcomes, and the need for realignment procedures led to a slower recovery. MRI evaluation showed some abnormal findings with the presence of bone overgrowth, but no correlation has been found with the clinical outcome.

Magnetic resonance-guided focused ultrasound treatment of extra-abdominal desmoid tumors: a retrospective multicenter study.

OBJECTIVES: To assess the feasibility, safety and preliminary efficacy of magnetic resonance-guided focused ultrasound (MRgFUS) for the treatment of extra-abdominal desmoid tumours. METHODS: Fifteen patients with desmoid fibromatosis (six males, nine females; age range, 7-66 years) were treated with MRgFUS, with seven patients requiring multiple treatments (25 total treatments). Changes in viable and total tumour volumes were measured after treatment. Efficacy was evaluated using an exact one-sided Wilcoxon test to determine if the median reduction in viable tumour measured immediately after initial treatment exceeded a threshold of 50 % of the targeted volume. Median decrease after treatment of at least two points in numerical rating scale (NRS) worst and average pain scores was tested with an exact one-sided Wilcoxon test. Adverse events were recorded. RESULTS: After initial MRgFUS treatment, median viable targeted tumour volume decreased 63 %, significantly beyond our efficacy threshold (P = 0.0013). Median viable total tumour volume decreased (105 mL [interquartile range {IQR}, 217 mL] to 54 mL [IQR, 92 mL]) and pain improved (worst scores, 7.5 ± 1.9 vs 2.7 ± 2.6, P = 0.027; average scores, 6 ± 2.3 vs 1.3 ± 2, P = 0.021). Skin burn was the most common complication. CONCLUSIONS: MRgFUS significantly and durably reduced viable tumour volume and pain in this series of 15 patients with extra-abdominal desmoid fibromatosis. KEY POINTS: • Retrospective four-centre study shows MRgFUS safely and effectively treats extra-abdominal desmoid tumours • This non-invasive procedure can eradicate viable tumour in some cases • Alternatively, MRgFUS can provide durable control of tumour growth through repeated treatments • Compared to surgery or radiation, MRgFUS has relatively mild side effects.

Hamstring graft tibial insertion preservation versus detachment in anterior cruciate ligament reconstruction: a prospective randomized comparative study.

BACKGROUND: Anterior cruciate ligament (ACL) reconstruction with hamstring graft (HG) is a commonly performed procedure. Despite the type of reconstruction chosen, the detached HG undergoes a remodeling process known as ligamentization. In order to shorten the ligamentization process, the maintenance of HG tibial insertion, aimed to spare the tendons vascular supply, has been postulated. The aim of this paper is to report the results of a prospective randomized study comparing clinical and MRI results between two different ACL reconstructive procedures with and without HG tibial insertion preservation. METHODS: Forty patients (mean age 27.5 ± 9.5 years) were enrolled and randomly divided into two groups. The study group underwent an ACL reconstruction using a distally inserted HG, while the control group underwent a technique encompassing HG tibial detachment. Subjective and objective IKDC score was administered preoperatively and at 3-, 6-, 12- and 24-month follow-up. Graft morphology was assessed through MRI evaluation performed at 6-month follow-up. RESULTS: Clinical results were excellent in both groups. Regarding MRI results, a better intra-articular graft morphology was observed in the study group (Tau = 0.313, p = 0.024). No differences in graft integration were noticed. CONCLUSION: The main finding of this preliminary study is that preservation of the hamstring tibial insertion seems to enhance graft ligamentization with improved morphology of the intra-articular portion of the graft compared to a detachment of the hamstring tendons from the tibial side. Further well-designed studies with higher number of patients as well as more serial MRI evaluations are required to validate these preliminary findings.

Anterior cruciate ligament injury: post-traumatic bone marrow oedema correlates with long-term prognosis.

PURPOSE: Bone marrow oedema (BME) in the knee is a feature of several pathological conditions, and it has been described with high frequency in patients with acute anterior cruciate ligament (ACL) injury. The aim of this study is to evaluate the significance of BME, assessed in MRIs performed for ACL injury, with regards to clinical outcome and return to sport. METHODS: A total of 134 patients (98 men, 36 women) with ACL tear and MRI knee scan within six months from trauma were analysed. The presence of BME was evaluated on MRI images considering: extension and hyperintensity, the WORMS score oedema classification, and measuring the BME area. The clinical results were documented by IKDC-subjective score and the sport activity level by Tegner score at a minimum of five years follow up. RESULTS: BME was present in 74 knees (55.2 %), with a mean area of 523 ± 370 mm². The presence of BME showed a gradual decrease over time (p = 0.008), being detectable in MRIs performed more than three months after trauma in just 25.0 % of cases. Although 54 % of the patients without BME after three months returned to their previous sport level, no patients with oedema reached a full sport recovery (p = 0.01). In the group that underwent ACL reconstruction, the BME area was significantly correlated with a return to the previous sport level at the mid/long-term follow-up (p = 0.038). CONCLUSIONS: BME is a common finding, which decreases over time after injury. However, when BME is still detectable it correlates with clinical prognosis, and even in sport-active patients undergoing ACL reconstruction, a higher BME area is a negative predictive factor for a successful outcome at the mid/long-term follow-up.

A one-step treatment for chondral and osteochondral knee defects: clinical results of a biomimetic scaffold implantation at 2 years of follow-up.

The increasing interest in the role of subchondral bone with regard to articular surface disease led to the development of new bioengineered strategies. Aim of this study is to evaluate the clinical and MRI outcome after the implantation of a nanostructured biomimetic three-phasic collagen-hydroxyapatite construct for the treatment of chondral and osteochondral defects of the knee in a large cohort of patients. Seventy-nine patients (63 M, 16 W), affected by grade III-IV femoral condyle or trochlea chondral lesions or osteochondritis dissecans (OCD) were consecutively treated. Mean age was 31.0 ± 11.3 years, mean lesion size was 3.2 ± 2.0 cm(2). Fifty patients underwent previous surgeries, concurrent procedures were necessary in 39 cases. The clinical outcome was evaluated using the IKDC and Tegner scores at 12 and 24 months of follow-up. At follow-up times an MRI was performed and evaluated with the MOCART score. All the scores improved significantly from the baseline. IKDC subjective score showed a further increase between 12 and 24 months of follow-up, and 82.2% of the patients improved their symptoms at the final evaluation. Patients affected by OCDs had better results than those with degenerative lesions. Some abnormal MRI findings were present, even though no correlation was found with the clinical outcome. This one-step biomimetic approach developed to favor osteochondral tissue regeneration is effective in treating knees affected by damages of the articular surface, leading to a significant clinical improvement. However, abnormal MRI findings were present, even if not correlated with the clinical outcome.

Biodegradable polyurethane meniscal scaffold for isolated partial lesions or as combined procedure for knees with multiple comorbidities: clinical results at 2 years.

PURPOSE: The aim of this study is to evaluate the safety and clinical efficacy of this novel polyurethane meniscal scaffold to treat partial meniscal loss. METHODS: Eighteen patients (11 men and 7 women, mean age: 45 years) affected by irreparable acute meniscal tears requiring partial meniscectomy or chronic prior loss of meniscal tissue were enrolled in the study. They underwent arthroscopic polyurethane meniscal scaffold implantation (13 medial and 5 lateral) and, in case of presence of other comorbidities, concurrent procedures were also performed. Patients were prospectively evaluated up to 2 years of follow-up through IKDC objective, IKDC subjective, and Tegner scores. Furthermore, MRI evaluation of the meniscal scaffold was performed. RESULTS: No major adverse events were observed. A statistically significant increase in all the clinical parameters considered was found. The IKDC objective score increased from 61 % of normal or nearly normal knees at basal evaluation to 94 % at 2 years of follow-up (p = 0.01). There was also a significant increase in the IKDC subjective score both at 6-12 months of follow-up (p = 0.03 and p < 0.005), which was confirmed at 24 months. The Tegner score also showed a significant increase from the pre-operative level (median value 2, range 1-5) to final evaluation (median value 3, range 2-5; p = 0.005), albeit not reaching the pre-injury sports activity level. CONCLUSIONS: The implantation of this novel polyurethane scaffold proved to be a safe and potentially effective procedure to treat partial meniscal loss with encouraging results at short-term follow-up. Further high-quality studies with larger numbers of patients and longer evaluation times are needed to confirm these preliminary data.

Is the clinical outcome after cartilage treatment affected by subchondral bone edema?

PURPOSE: Subchondral bone edema is a common finding after cartilage treatment, but its interpretation is still debated. The aim of this study is to analyse the presence of edema after matrix-assisted autologous chondrocyte transplantation (MACT) for knee cartilage lesions at different follow-up times and its correlation with the clinical outcome. METHODS: Two hundred and forty-eight magnetic resonance imagings (MRIs) of patients treated with a hyaluronic acid-based MACT for lesions of the knee articular surface were considered. The MRIs belonged to 116 patients (mean age at surgery 28.6 ± 10.3 years, average defect size 2.4 ± 1.0 cm(2)), 57 affected by degenerative cartilage lesions, 27 traumatic and 32 were osteochondritis dissecans (OCD). MRI follow-up was performed from 6 to 108 months after treatment. Other than its presence or absence, the subchondral bone edema was evaluated using a 3-level grading considering extension and hyperintensity, and with the WORMS score edema classification. The IKDC subjective score was collected at the time of every MRI. RESULTS: An analysis of the entire MRI group showed that edema is not constantly present through the follow-up, but presents a particular and well-defined trend. Edema was present within the first 2 years and was then markedly reduced or disappeared at 2 and 3 years (p = 0.044). Afterwards the level of edema increased again (p < 0.0005) and remained steadily present at medium/long-term follow-up. Patellar lesions presented significantly lower edema (p = 0.012), whereas OCD lesions presented more edema at all follow-up (p = 0.002) and a different trend, with an increasing level of edema over time. No correlation was found between edema and clinical outcome. CONCLUSIONS: Edema after MACT is present during the first phases of cartilage maturation up to 2 years of follow-up, and then tends to disappear. However, after a few years, it tends to reappear. Less edema was found in the patella, whereas more edema was found in the OCD, where subchondral bone is primarily involved. Interestingly, the presence of edema was not correlated with a poorer clinical outcome. Whether this might be a prognostic factor at longer follow-up remains to be determined, but our results give some indication on what to expect on both MRI edema and clinical outcome after MACT. LEVEL OF EVIDENCE: Case series, Level IV.

Clinical results and MRI evolution of a nano-composite multilayered biomaterial for osteochondral regeneration at 5 years.

BACKGROUND: Several cartilage lesions involve the subchondral bone, and there is a need for biphasic scaffolds to treat the entire osteochondral unit to reproduce the different biological and functional requirements and guide the growth of the 2 tissues. PURPOSE: To evaluate the results of a cell-free collagen-hydroxyapatite osteochondral scaffold at midterm, and to use magnetic resonance imaging (MRI) analysis to document the imaging evolution of the tissue regeneration process through 5 years of follow-up. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Twenty-seven patients (9 women, 18 men; mean age, 34.9 ± 10.2 years) treated for knee chondral or osteochondral lesions (size, 1.5-6 cm(2)) were followed for 2 and 5 years and were clinically evaluated using the International Knee Documentation Committee (IKDC) and Tegner scores. An MRI evaluation was performed at both follow-ups in 23 lesions, and the magnetic resonance observation of cartilage repair tissue (MOCART) score and specific subchondral bone parameters (bone regeneration, bone signal quality, osteophytes or upcoming bone front, sclerotic areas, and edema) were analyzed. RESULTS: A statistically significant improvement in all clinical scores was observed from the initial evaluation to the 2- and 5-year follow-ups, and the results were stable over time. The mean IKDC subjective score improved from 40.0 ± 15.0 to 76.5 ± 14.5 (2-year follow-up) and 77.1 ± 18.0 (5-year follow-up) and the mean Tegner score from 1.6 ± 1.1 to 4.0 ± 1.8 (2-year follow-up) and 4.1 ± 1.9 (5-year follow-up). The MRI evaluation showed a significant improvement in both the MOCART score and subchondral bone status from 2 to 5 years. At 5 years, complete filling of the cartilage was shown in 78.3% of the lesions, complete integration of the graft was detected in 69.6% of cases, the repair tissue surface was intact in 60.9%, and the structure of the repair tissue was homogeneous in 60.9% of the cases. No correlation was found between MRI findings and clinical outcome. CONCLUSION: This osteochondral scaffold was used for the treatment of chondral and osteochondral knee defects with a single-step procedure. The study results highlighted the safety and potential of this procedure, which offered a good clinical outcome with stable results at midterm follow-up. Although the MRI findings improved over time, some abnormalities persisted, but no correlation was found between the imaging and clinical results.

Treatment of knee osteochondritis dissecans with a cell-free biomimetic osteochondral scaffold: clinical and imaging evaluation at 2-year follow-up.

BACKGROUND: Osteochondritis dissecans (OCD) is an acquired lesion of the subchondral bone that may result in separation and instability of the overlying articular cartilage. Unstable lesions must be treated surgically to reestablish the joint surface as anatomically as possible. Hypothesis/ PURPOSE: The aim of this study was to evaluate the potential of a biomimetic osteochondral scaffold to treat OCD by analyzing the results obtained at 2-year follow-up. The hypothesis was that this scaffold, which was developed to treat the entire osteochondral unit, might restore the articular surface and improve symptoms and function in patients affected by knee OCD. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Twenty-seven consecutive patients (19 men, 8 women; age [mean ± SD], 25.5 ± 7.7 years) who were affected by symptomatic knee OCD of the femoral condyles (average defect size 3.4 ± 2.2 cm(2)), grade 3 or 4 on the International Cartilage Repair Society (ICRS) scale, were enrolled and treated with the implantation of a 3-layer collagen-hydroxyapatite scaffold. Patients were prospectively evaluated by subjective and objective International Knee Documentation Committee (IKDC) and Tegner scores preoperatively and at 1- and 2-year follow-up. An MRI was also performed at the 2 follow-up times. RESULTS: A statistically significant improvement in all clinical scores was obtained at 1 year, and a further improvement was found the following year. At the 2-year follow-up, the IKDC subjective score had increased from 48.4 ± 17.8 preoperatively to 82.3 ± 12.2, the IKDC objective evaluation from 40% to 85% of normal knees, and the Tegner score from 2.4 ± 1.7 to 4.5 ± 1.6. The MRI evaluations showed good defect filling and implant integration but also inhomogeneous regenerated tissue and subchondral bone changes in most patients at both follow-up times. No correlation between the MOCART (magnetic resonance observation of cartilage repair tissue) score and clinical outcome was found. CONCLUSION: This biomimetic osteochondral scaffold seems to be a valid treatment option for knee OCD, showing a good clinical outcome at 2-year follow-up. Moreover, the improvement was not correlated with lesion size, so large lesions can benefit from this implant. Less favorable findings were obtained with MRI evaluation.