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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_1 | Pages 47 - 47
2 Jan 2024
Grammens J Pereira LF Danckaers F Vanlommel J Van Haver A Verdonk P Sijbers J
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Currently implemented accuracy metrics in open-source libraries for segmentation by supervised machine learning are typically one-dimensional scores [1]. While extremely relevant to evaluate applicability in clinics, anatomical location of segmentation errors is often neglected.

This study aims to include the three-dimensional (3D) spatial information in the development of a novel framework for segmentation accuracy evaluation and comparison between different methods.

Predicted and ground truth (manually segmented) segmentation masks are meshed into 3D surfaces. A template mesh of the same anatomical structure is then registered to all ground truth 3D surfaces. This ensures all surface points on the ground truth meshes to be in the same anatomically homologous order. Next, point-wise surface deviations between the registered ground truth mesh and the meshed segmentation prediction are calculated and allow for color plotting of point-wise descriptive statistics. Statistical parametric mapping includes point-wise false discovery rate (FDR) adjusted p-values (also referred to as q-values).

The framework reads volumetric image data containing the segmentation masks of both ground truth and segmentation prediction. 3D color plots containing descriptive statistics (mean absolute value, maximal value,…) on point-wise segmentation errors are rendered. As an example, we compared segmentation results of nnUNet [2], UNet++ [3] and UNETR [4] by visualizing the mean absolute error (surface deviation from ground truth) as a color plot on the 3D model of bone and cartilage of the mean distal femur.

A novel framework to evaluate segmentation accuracy is presented. Output includes anatomical information on the segmentation errors, as well as point-wise comparative statistics on different segmentation algorithms. Clearly, this allows for a better informed decision-making process when selecting the best algorithm for a specific clinical application.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_9 | Pages 79 - 79
17 Apr 2023
Stockmann A Grammens J Lenz J Pattappa G von Haver A Docheva D Zellner J Verdonk P Angele P
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Partial meniscectomy patients have a greater likelihood for the development of early osteoarthritis (OA). To prevent the onset of early OA, patient-specific treatment algorithms need to be created that predict patient risk to early OA after meniscectomy. The aim of this work was to identify patient-specific risk factors in partial meniscectomy patients that could potentially lead to early OA.

Partial meniscectomy patients operated between 01/2017 and 12/2019 were evaluated in the study (n=317). Exclusion criteria were other pathologies or surgeries for the evaluated knee and meniscus (n = 114). Following informed consent, an online questionnaire containing demographics and the “Knee Injury and Osteoarthritis Outcome Score” (KOOS) questionnaire was sent to the patient. Based on the KOOS pain score, patients were classified into “low” (> 75) and “high” (< 75) risk patients, indicating risk to symptomatic OA. The “high risk” patients also underwent a follow-up including an MRI scan to understand whether they have developed early OA.

From 203 participants, 96 patients responded to the questionnaire (116 did not respond) with 61 patients considered “low-risk” and 35 “high-risk” patients. Groups that showed a significant increased risk for OA were patients aged > 40 years, females, overweight (BMI >25 kg/m2 ≤ 30 kg/m2), and smokers (*p < 0.05). The “high-risk”-follow-up revealed a progression of early osteoarthritic cartilage changes in seven patients, with the remaining nineteen patients showing no changes in cartilage status or pain since time of operation. Additionally, eighteen patients in the high-risk group showed a varus or valgus axis deviation.

Patient-specific factors for worse postoperative outcomes after partial meniscectomy and indicators for an “early OA” development were identified, providing the basis for a patient-specific treatment approach. Further analysis in a multicentre study and computational analysis of MRI scans is ongoing to develop a patient-specific treatment algorithm for meniscectomy patients.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_4 | Pages 120 - 120
1 Mar 2021
Grammens J Peeters W Van Haver A Verdonk P
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Trochlear dysplasia is a specific morphotype of the knee, characterized by but not limited to a specific anatomy of the trochlea. The notch, posterior femur and tibial plateau also seem to be involved. In our study we conducted a semi-automated landmark-based 3D analysis on the distal femur, tibial plateau and patella.

The knee morphology of a study population (n=20), diagnosed with trochlear dysplasia and a history of recurrent patellar dislocation was compared to a gender- and age-matched control group (n=20). The arthro-CT scan-based 3D-models were isotropically scaled and landmark-based reference planes were created for quantification of the morphometry. Statistical analysis was performed to detect shape differences between the femur, tibia and patella as individual bone models (Mann-Whitney U test) and to detect differences in size agreement between femur and tibia (Pearson's correlation test).

The size of the femur did not differ significantly between the two groups, but the maximum size difference (scaling factor) over all cases was 35%. Significant differences were observed in the trochlear dysplasia (TD) versus control group for all conventional parameters. Morphometrical measurements showed also significant differences in the three directions (anteroposterior (AP), mediolateral (ML), proximodistal (PD)) for the distal femur, tibia and patella. Correlation tests between the width of the distal femur and the tibial plateau revealed that TD knees show less agreement between femur and tibia than the control knees; this was observed for the overall width (TD: r=0.172; p=0.494 - control group: r=0.636; p=0.003) and the medial compartment (TD: r=0.164; p=0.516 - control group: r=0.679; p=0.001), but not for the lateral compartment (TD: r=0.512; p=0.029 - control: r=0.683; p=0.001). In both groups the intercondylar eminence width was strongly correlated with the notch width (TD: r=0.791; p=0.001 - control: r=0.643; p=0.002).

The morphology of the trochleodysplastic knee differs significantly from the normal knee by means of an increased ratio of AP/ML width for both femur and tibia, a smaller femoral notch and a lack of correspondence in mediolateral width between the femur and tibia. More specifically, the medial femoral condyle shows no correlation with the medial tibial plateau.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 36 - 36
1 Dec 2020
Genechten WV Vuylsteke K Martinez PR Swinnen L Verdonk P
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Autologous micro-fragmented adipose tissue (MFAT) for the treatment of symptomatic knee osteoarthritis (OA) is gaining interest although there is still a lack of supportive data on safety and clinical efficacy. This study primarily aimed to identify patient- and pathology-related parameters to tighten patient selection criteria for future clinical MFAT application. Secondly, the overall (1) therapeutic response rate (TRR), (2) short-term clinical effect, (3) effect durability and (4) therapeutic safety was investigated at a minimal follow-up of 1 year.

Sixty-four subjects (91 knees) with symptomatic knee OA (mild-severe on MRI) were enrolled in a prospective single-centre case series. Ethical approval was obtained from the local and academic ethical committee (#B300201733775). After liposuction, the adipose tissue was mechanically processed in a Lipogem® device which eventually produced 6–9cc MFAT. Subjects were clinically assessed by means of the KOOS, NRS, UCLA and EQ-5D at baseline and 1, 3, 6 and 12 months after injection. Adverse events were meticulously recorded. The TRR was defined according to the OMERACT-OARSI criteria. A baseline MRI was scored following the MOAKS system. Paired sample t-tests, independent t-test and Fischer's exact test were applied on appropriate variables. Multiple regression models were fit separately for patient-and pathology-specific factors. Significance level was set at α=0.05.

The overall TRR was 66% at 3 months and 50% at 12 months after injection. Subgroup analysis revealed that specifically patients with no-mild bone marrow lesions (BML) had a TRR of 88% at 3 months and 75% at 12 months after MFAT injection. Therapy responders at these timepoints improved with 29.3±14.1 points and 30.8±15.3 points on KOOS pain, while non-responders deteriorated mildly. All clinical scores were significantly higher at follow-up compared to baseline (p<0.05). BMI (factor 0.17, p=0.002) and age (factor −0.48, p=0.048) were prognosticators for the TRR% at 1 month and for absolute KOOS pain improvement at 6 months, respectively. Posterior horn lesions (PHL) in the medial meniscus (p<0.001) and bone marrow lesions (p=0.003) were negative prognosticators for the TRR at respectively 6 and 12 months post-injection. An inflammatory reaction (pain, swelling or stiffness) to MFAT was reported in 79% knees and resolved spontaneously within 16.6±13.5 days after administration.

The study showed a durable and satisfying TRR (up to 75% at 1 year in selected patients without BML) and clinical improvement after a single intra-articular injection with autologous MFAT. The availability of an index knee MRI is mandatory to select MFAT patients, preferably with no or mild BML and without PHL of the medial meniscus. High BMI and younger age are associated with better early outcomes. In comparison to other injection therapies such as cortisone, hyaluronic acid and PRP, MFAT appears very attractive with an effect durability of at least 1 year.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 49 - 49
1 Feb 2017
Huey V Brenkel I Chang C Clatworthy M Hamilton W Howard J Kantor S Lesko J Nunley R Whittaker J Verdonk P
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Introduction

With the introduction of new technology in orthopaedics, surgeons must balance anticipated benefits in patient outcomes with challenges or complications associated with surgical learning curve for the technology. The purpose of this study was to determine whether the surgeon learning curve with a new multi-radius primary TKA system (primary TKA implant and instruments) designed for surgical team ease would impact clinical outcomes, surgical time and complications.

Materials & Methods

From November 2012 to July 2015, 2369 primary TKAs were prospectively enrolled in two multicenter studies across 50 sites in 14 countries with a new knee system (ATTUNE®) evenly balanced across four configurations: cruciate retaining or posterior stabilised with either fixed bearing or rotating platform (CRFB, CRRP, PSFB, PSRP). 2261 knees had a <1 year visit and 1628 had a greater than 1 year visit. These knees were compared to a reference dataset of 845 primary TKAs from three manufacturers in the same four configurations with currently available products (CURRENT-TKA). Demographics for ATTUNE and CURRENT-TKA were similar and typical for primary TKA. Operative times, clinical outcomes and a series of five patient reported outcomes were compared for ATTUNE vs. CURRENT-TKA. The first 10 ATTUNE subjects for each surgeon were defined as learning curve cases (N=520) and were compared to all later subjects (N=1849) and also with the CURRENT-TKA cases (N=845). Patient reported outcome measures and clinical outcome analyses were adjusted for covariates including patient demographics, pre-op assessment and days post-op.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 80 - 80
1 Feb 2017
Van Haver A Kolk S DeBoodt S Valkering K Verdonk P
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Introduction

Accurate placement of total knee arthroplasty (TKA) components is critical for obtaining good long-term clinical outcome. Several contemporary CT- or MRI-based technologies allow surgeons to pre-plan TKA and translate that planning into the operating room. To evaluate TKA component placement, post-operative CT or MRI scans allow comprehensive 3D measurements. However, these are expensive and difficult to obtain in large numbers, and yield an additional radiation dose to the patient (in case of CT). A potential solution to overcome these hurdles exists in using 2D/3D registration techniques. In this technique, a new tool (the X-ray Module, Mimics®, Materialise NV) is used to align one or more post-operative X-rays with the preoperative CT- or MRI-based 3D planning (Figure 1). The aim of this study was to determine the accuracy of this 2D/3D registration technique for determining 3D position of TKA implant components postoperatively.

Materials and Methods

A TKA was performed in six human cadaver legs. A CT scan was acquired preoperatively and the bones were segmented using Mimics® to obtain 3D bone models. Post-operatively, a high-resolution CT scan with minimization of metal scatters was acquired and bones and implant components were segmented in Mimics® to obtain the ground truth for their relative position. To apply the novel X-ray based post-op analysis, conventional anteroposterior and lateral radiographs were obtained. The accuracy of the X-ray tool was determined by calculating the angles (varus/valgus, flexion/extension, external/internal rotations) and the distances (anterior/posterior, proximal/distal, medial/lateral) between the centers of gravity of the implants from the X-ray based method and the CT-based ground truth in the anatomical coordinate system of the bone. X-ray based alignment was assessed by an orthopedic surgeon (3 repetitions) and Bland-Altman plots were created to visualize the differences between the ground truth and the X-ray based assessment of the implant position.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_20 | Pages 88 - 88
1 Nov 2016
Howard J Brenkel I Chang C Clatworthy M Hamilton W Howard J Huey V Kantor S Lesko J Nunley R Verdonk P
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With the introduction of new technology in orthopaedics, surgeons must balance anticipated benefits in patient outcomes with challenges or complications associated with surgical learning curve for the technology. The purpose of this study was to determine whether surgeon learning curve with a new multi-radius primary TKA system and instruments designed to improve surgical team ease would impact clinical outcomes, surgical time, and complications.

From November 2012 to July 2015, 2369 primary TKAs were prospectively enrolled in two multicentre studies across 50 sites in 14 countries with a new knee system (NEW-TKA) evenly balanced across four configurations: cruciate retaining or posterior stabilised with either fixed bearing or rotating platform (CRFB, CRRP, PSFB, PSRP). 2128 knees had a<1 year visit and 1189 had a minimum 1 year visit. These knees were compared to a reference dataset of 843 primary TKAs from three manufacturers in the same four configurations with currently available products (CA-TKA). Demographics for NEW-TKA and CA-TKA were similar and typical for primary TKA. Operative times, clinical outcomes and a series of five patient reported outcomes were compared for NEW-TKA vs. CA-TKA. The first 10 New-TKA subjects for each surgeon were defined as learning curve cases (N=520) and were compared to all later subjects (N=1849). Patient reported outcome measure and clinical outcome analyses were covariate adjusted for patient demographics, pre-op assessment and days post-op.

Mean (SD) surgical time for NEW-TKA learning curve cases was 79.1 (24.3) minutes, which reduced thereafter to 73.6 (24.3) (p=0.002). Beyond 10 cases, there was a continued reduction in NEW-TKA surgical time (R-Squared = 0.031). After 10 cases, surgical time was on par with the mean (SD) 71.9 (21.6) for CA-TKA (p=0.078). PROM outcomes of the first 10 learning curve cases for NEW-TKA were not statistically different from later cases at less than 1 year or later when adjusted for relevant covariates including configuration, patient demographics, pre-op functional status, and time post-op (p-values > 0.01). PROM outcomes for NEW-TKA vs. CA-TKA under the same covariate adjustments showed a trend favoring KOOS ADL, Symptoms, and Sport and Recreation subscores at minimum 1 year (p-values < 0.01). The incidence of intraoperative operative site complications was 1.3% for the NEW-TKA learning curve cases which was similar to the 0.6% rate for historical CA-TKA (p=0.231) and the intraoperative complication rate for the NEW-TKA later cases was consistent with learning curve cases (p=0.158).

The introduction of new implants into the market place needs to have adequate data to support that they are safe and effective. Except for a minor increase in surgical time during the first 10 patients, this study found that surgeon learning curve with this new primary TKA system does not adversely affect patient short term outcomes and complication rates.


The Bone & Joint Journal
Vol. 97-B, Issue 3 | Pages 318 - 323
1 Mar 2015
Verdonk P Dhollander A Almqvist KF Verdonk R Victor J

The treatment of osteochondral lesions is of great interest to orthopaedic surgeons because most lesions do not heal spontaneously. We present the short-term clinical outcome and MRI findings of a cell-free scaffold used for the treatment of these lesions in the knee. A total of 38 patients were prospectively evaluated clinically for two years following treatment with an osteochondral nanostructured biomimetic scaffold. There were 23 men and 15 women; the mean age of the patients was 30.5 years (15 to 64). Clinical outcome was assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Tegner activity scale and a Visual Analgue scale for pain. MRI data were analysed based on the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system at three, 12 and 24 months post-operatively. There was a continuous significant clinical improvement after surgery. In two patients, the scaffold treatment failed (5.3%) There was a statistically significant improvement in the MOCART precentage scores. The repair tissue filled most of the defect sufficiently. We found subchondral laminar changes in all patients. Intralesional osteophytes were found in two patients (5.3%). We conclude that this one-step scaffold-based technique can be used for osteochondral repair. The surgical technique is straightforward, and the clinical results are promising. The MRI aspects of the repair tissue continue to evolve during the first two years after surgery. However, the subchondral laminar and bone changes are a concern.

Cite this article: Bone Joint J 2015; 97-B:318–23.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 91 - 91
1 Sep 2012
Verdonk P De Coninck T Huysse W Verdonk R
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Purpose

to evaluate the radial displacement of meniscal allograft transplants (MATs) in patients operated with an open technique vs. an arthroscopic technique at 1 year postoperatively. Radial displacement or extrusion of the graft is frequently observed after meniscus transplantation. The hypothesis is that arthroscopically inserted MATs extrude less than open MATs and therefore have a more intra-articular position than open surgery transplants.

Materials and Methods

39 patients were included in the study: the first group of open surgery transplants consisted of 16 patients (10 lateral, 6 medial). The second group of arthroscopic transplants consisted of 21 patients (14 lateral, 7 medial). MR-images were taken one year post-surgery. The displacement, evaluated on 1,5T MR coronal images, was defined as the distance between the tibial plateau and the outer edge of the meniscus.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 93 - 93
1 Sep 2012
Van Der Maas J Verdonk P Tampere T Almqvist F Verdonk R
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Background

There is growing evidence in literature that meniscal allograft transplantation performed with the right indications results in significant pain relief and functional improvement of the involved joint. Long-term data on clinical and radiological outcome are however scarce.

Methods

We evaluated 89 transplants (53 lateral and 36 medial) in 87 patients. Mean time of follow-up was 15,5 ± 2,85 years (range 9,9–20,4), mean age at surgery was 35,2 years (range 22–50). Clinically, the patients were evaluated using a KOOS, SF-36, HSS, VAS, Tegner and Lysholm score. HSS scores were compared to pre-operative and mid-term follow-up data. Each patient received radiographs (AP, profile and Rosenberg view). Radiological outcome parameters were joint space width narrowing and Fairbank changes and were scored according to IKDC. Failures were defined as patients who were converted to an arthroplasty.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 125 - 125
1 Sep 2012
Elsner J Condello V Zorzi C Verdonk P Arbel R Hershman E Guilak F Shterling A Linder-Ganz E Nocco E
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Statement of Purpose

Meniscal tears are common knee injuries that subsequently lead to degenerative arthritis, attributed to changes in stress distribution in the knee. In such cases there is need to protect the articular cartilage by repairing or replacing the menisci. While traditionally, meniscal replacement involves implantation of allografts, problems related to availability, size matching, cost and risk of disease transmission limit their use. Another optional treatment is that of biodegradable scaffolds which are based principally on tissue engineering concepts. The variability in body response to biodegradable implants and the quality of the tissue formed still pose a problem in this respect, under intense knee loading conditions. Moreover, biological solutions are mostly limited to younger patients <40 years old. Therefore, the goal of this study was, to develop a synthetic meniscal implant which can replace the injured meniscus, restore its function, and relieve pain.

Methods

A composite, non-fixed self-centering discoid-shaped meniscus implant (NUsurafce®, AIC, Memphis, TN), composed of polycarbonate-urethane (PCU) and reinforced circumferentially with UHMWPE fibers is proposed (Fig. 1). The implant geometry was based on an extensive MRI study of over 100 knee scans [1]. The proposed structure aims to mimic the circumferential collagen reinforcement of the natural meniscus. Biomechanical evaluation of the implant was focused on in-vitro measurements of contact pressure under the implant in cadaver knees and computational finite element (FE) analyses [2,3]. Pressure distribution on the tibial plateau (under the meniscus implant) was measured by pressure sensitive films (Tekscan, MA) and quantified with respect to the natural meniscus. FE analyses were used to evaluate internal stress and strains, and to support the selection of optimal implant configuration. The last pre-clinical step was a large-animal (sheep) study in which the cartilage condition was evaluated microscopically over six months [4].


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 123 - 123
1 Sep 2012
Dhollander A Verdonk P Verdonk R Verbruggen G Almqvist K
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Aim

The present study was designed to evaluate the implantation of alginate beads containing human mature allogenic chondrocytes for the treatment of symptomatic cartilage defects in the knee.

Methods

A biodegradable, alginate-based biocompatible scaffold containing human mature allogenic chondrocytes was used for the treatment of chondral and osteochondral lesions in the knee. Twenty-one patients were clinically prospectively evaluated with use of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a Visual Analogue Scale (VAS) for pain preoperatively and at 3, 6, 9, 12, 24 and 36 months of follow-up.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 92 - 92
1 Sep 2012
Verdonk P Beekman P De Coninck T Verdonk R Raat F
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Purpose

to evaluate the kinematics of a knee with a polyurethane meniscal scaffold for partial meniscus defect substitution during flexion under weightbearing conditions in an upright MRI. In addition, radial displacement and the surface of the scaffold was compared to the normal meniscus.

Materials and Methods

One cadaver with a normal lateral meniscus and medial scaffold in the left knee and with a normal medial meniscus and lateral scaffold in the right knee. The scaffolds were implanted to substitute a 3 cm meniscus defect in the posterior horn. The cadaver was scanned in an 0,7T open MRI with a range of motion from 0-30-60-90 to hyperflexion. Kinematics were evaluated on sagittal images by the following two parameters: the position of the femoral condyle, identified by the centre of its posterior circular surface, which is named the flexion facet centre (FFC), and the point of closest approximation between the femoral and tibial subchondral plates, the contact point (CP). Both were identified in relation to the posterior tibial cortex.

The displacement, measured on coronal images, is defined as the distance between the tibial plateau and the outer edge of the meniscus. The surface was also measured on coronal slices and contains the triangular surface of the meniscus.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIX | Pages 16 - 16
1 Jul 2012
Verdonk P Huysse W Forsyth R
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Purpose

To assess performance of a polyurethane scaffold designed to facilitate regrowth of tissue after irreparable partial meniscus tissue loss.

Methods

Fifty-two subjects with irreparable medial or lateral meniscus tissue lesions with intact rim, presence of both horns and stable, well aligned knees, were treated with the scaffold. Tissue ingrowth was assessed using dynamic contrast enhanced MRI (DCE-MRI) at 3 months (n=43), and by histological examination of biopsies (n=44) at 12 months relook arthroscopy. Cartilage status on MRI at 1week, 3, 12 and 24 months, and clinical outcomes were assessed from baseline to 24 months using Visual Analogue Scale (VAS), Knee and Osteoarthritis Outcome Score (KOOS), Lysholm and International Knee Documentation Committee (IKDC).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IX | Pages 17 - 17
1 Mar 2012
Verdonk P Huysse W Verdonk R
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Purposes of the study

To assess the performance of an acellular synthetic scaffold in the treatment of painful partial meniscal tissue loss.

Methods

Subjects recruited (n=52) had irreparable medial or lateral meniscus partial meniscus loss, intact rim, presence of both horns and a stable well aligned knee.

Diagnostic imaging was used to assess tissue ingrowth at 3 months post-implantation by evidence of vascularisation in the scaffold using DCE-MRI with intravenous gadolinium contrast material (n=42). All DCE-MRI scans were assessed centrally for neovascularisation in the peripheral half of the scaffold meniscus and integration of the implanted device. Stability of tissue ingrowth and cartilage scores in the index compartment were assessed at 12 and 24 months post-implantation using anatomic MRI scans.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IX | Pages 47 - 47
1 Mar 2012
Almqvist K Vanlauwe J Saris D Victor J Verdonk P Bellemans J Verdonk R
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Introduction

Autologous chondrocyte implantation presents a viable alternative to microfracture in the repair of damaged articular cartilage of the knee; however, outcomes for patellar lesions have been less encouraging. ChondroCelect (CC) is an innovative, advanced cell therapy product consisting of autologous cartilage cells expanded ex vivo through a highly controlled and consistent manufacturing process.

Purpose

To assess the effect of CC in the treatment of patellofemoral lesions, for which standard treatment options had failed and/or no other treatment options were considered feasible.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 508 - 508
1 Oct 2010
Verdonk P Forsyth R Verdonk R
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Introduction: Partial meniscectomy is the preferred treatment option for patients with irreparable meniscal tears. While generally accepted as producing favorable clinical results in the short run, it is widely accepted that meniscectomy induces articular cartilage degeneration in the long run. Thus, tissue regeneration post-meniscectomy is a desirable therapeutic approach in order to restore the function of the meniscus, thereby preventing long-term damage. A novel device, designed to act as a scaffold for blood vessel ingrowth and meniscal tissue regeneration in patients with irreparable meniscus tears and meniscal tissue loss, has recently been developed.

Methods: Fifty-two patients with an irreparable medial or lateral meniscal tear or partial meniscus loss, with intact rim, were treated with the meniscal scaffold in this prospective, non-randomised, single-arm, multi-centre clinical study. To date, biopsy samples 12 months post-implantation harvested from the center of the inner rim of the implanted scaffold meniscus using a standardized biopsy harvest protocol are available from 9 of the 52 patients. Histochemical staining was performed with haematoxylin and eosin, Masson’s trichrome, Sirius Red and combined Periodic Acid Schiff-Alcian Blue (PAS-AB). Immunohistochemistry was performed using the cartilage markers S100, the vessel markers CD31 and CD34, the smooth muscle marker SMA, and the histiocytic marker CD68.

Results: All biopsies showed fully vital material, with no signs of necrosis or cell death. In addition to a fibrous capsule, 3 distinct zones were identified based on the presence or absence of vessel structures, cellular morphology, and composition of extracellular matrix. Zone 1, a vascularized, fibrotic zone, mainly consisting of fibroblasts, was observed in 4/9 biopsies. Zone 2, an avascular and loose collagenized zone, consisting of a mixture of fibroblasts and chondrofibroblast-like cells, and Zone 3, an avascular and fibrin-rich zone, consisting of fibrochondroblast-like cells, were evident in all 9 biopsies.

Conclusions: All biopsies showed complete re-population, and thus can be regarded as vital structures, illustrating the biocompatibility of the meniscal scaffold. Moreover, zonal organisation, each with its own histological characteristics, suggests an ongoing process of regeneration, maturation and integration towards meniscus-like tissue. These data offer a first insight into the complex human healing potential after implantation of a polyurethane meniscus scaffold.

On behalf of the Actifit Study Group: R Verdonk, P Beaufils, J Bellemans, P Colombet, R Cugat, P Djian, H Laprell, P Neyret, H Paessler,


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 504 - 504
1 Oct 2010
Huysse W Verdonk P Verdonk R
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Introduction: Partial and total meniscectomy has been shown to result in cartilage degeneration and osteoarthritis in the long term. Thus, research efforts have focused on tissue regeneration following meniscectomy. A novel device has recently been developed which, when implanted in the meniscus, provides a three-dimensional honeycombed matrix for vascular ingrowth and tissue regeneration to replace lost meniscus tissue. To evaluate this vascular ingrowth and tissue regeneration a Dynamic contrast-enhanced MRI non invasive technique was used.

Methods: A prospective, non-randomised, single-arm, multi-centre, clinical investigation was conducted in 52 patients with an irreparable medial or lateral meniscal tear or partial meniscus loss, with intact rim. Patients were required to have a stable knee joint or be a candidate for knee joint stabilization within 12 weeks of the index procedure, have an International Cartilage Repair Society (ICRS) classification of Grade I or II, and have undergone no more than 3 previous surgeries on the index knee. Following implantation of the novel scaffold, dynamic contrast-enhanced magnetic resonance imaging (DCMRI) using intravenous gadolinium contrast material was performed at 1 week, and at 3 and 12 months post-implantation. Because the scaffold and normal meniscus tissue lack vascularity, the presence of signal enhancement in the device is an appropriate surrogate for the ingrowth of blood vessels and native tissue into the scaffold. All scans were assessed for neovascularization in the scaffold meniscus and integration of the implanted device. To date DCMRI scans at 3 months are available for 48 of the 52 patients. Full data for all available patients will be presented.

Results: Using this non-invasive technique evaluable DCMRI data at 3 months were obtained for 42 of the 48 patients (87.5%), showing vascularity, and therefore the presence of tissue, in 35 of the 48 (72.9%) patients. No enhancement (vascularity) was demonstrated in 6 of the 48 (12.5%) patients.

Conclusions: At 3 months post-implantation, vascularization, and therefore tissue ingrowth, was demonstrated using DCMRI in the vast majority of patients treated with the novel meniscus scaffold.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 508 - 508
1 Oct 2010
Verdonk P Mulliez A Verdonk R
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Background: There are several surgical options for recurrent lateral dislocations of the patella. As the reconstruction of the medial patellofemoral ligament reconstruction (MPFL) has been proven to restore stability, it has become more accepted by surgeons. No study to date has examined the difference in clinical outcome between patients with a primary MPFL reconstruction (group 1) versus MPFL reconstruction in patients with a previously failed patellar stabilizing operations (transposition of tibial tuberosity, trochleoplasty, medial raphy) (group 2).

Study type: Prospective cohort study

Methods: 30 patients have been treated with an MPFL reconstruction for episodic patellar dislocation between april 2007 and april 2008. 12 of them already had a patellar stabilizing operation in the history (group 2). The clinical follow up was done by the KOOS and KUJULA scores.

Results: For both groups, the KOOS and KUJALA score increased significantly at final follow-up. KOOS pain and ADL subscore had the lowest increase. At final follow-up, the KUJALA and KOOS score were significantly higher for group 1 vs group 2. The net gain for both KOOS and KUJALA was also significantly higher in group 1 compared to group 2.

Conclusions: MPFL reconstruction is a viable treatment option for episodic patellar dislocation both in a primary setting as well as in a secondary setting for failed surgery cases. The net clinical gain is nevertheless significantly higher in primary cases.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 508 - 508
1 Oct 2010
Verdonk R Verdonk P
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Introduction: Currently, partial meniscectomy represents the only viable treatment option for patients with irreparable meniscal tears; however, functional limitations have been reported both in the short- and long-term. Furthermore, over time, removal of knee meniscus tissue leads to degenerative joint changes and osteoarthritis. Given the limited alternatives to meniscus removal, researchers have developed a novel meniscal scaffold. Upon implantation to the vascularized portion of the meniscus, the scaffold allows the ingrowth of blood vessels, facilitating the regeneration of meniscal tissue.

Methods: A total of 52 patients with an irreparable medial or lateral meniscal tear or partial meniscus loss (with intact rim) were recruited into this prospective, non-randomised, single-arm, multi-centre clinical study. Patients were to have a stable knee joint or be a candidate for joint stabilization within 12 weeks of the procedure, an International Cartilage Repair Society (ICRS) classification ≤ 2, and no more than 3 prior surgeries on the index knee. Post-implantation, clinical efficacy was assessed at each follow-up visit based on the following patient-reported outcome scores: Visual Analogue Scale (VAS) score for pain, and both the Knee and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) score for function. Preliminary efficacy data are available for 48/52 patients at 3 months follow-up and 35/52 patients at 6 months follow-up. Full data, including 12 months follow-up for all available patients will be presented.

Results: Compared to the mean baseline values, a statistically significant reduction in post-operative knee pain was reported based on VAS both at 3 and 6 months. Statistically significant improvements compared to baseline were also reported in IKDC scores and all components of the KOOS questionnaire both at 3 and 6 months post implantation.

Conclusions: These promising clinical results clearly illustrate the early efficacy of this novel meniscus implant for partial meniscus tissue loss. Longer follow-up is however needed to establish its full potential.