K. Zaslav (Richmond, US)

Ortho Virginia Sports Medicine and Cartilage Restoration Center

Presenter Of 4 Presentations

Podium Presentation Meniscus

12.3.1 - Clinical Results of the NUsurface® Implant vs Non-Surg Controls: First 100 Patients from RCT and Single-Arm Observational Study at 12 Months

Presentation Number
12.3.1
Presentation Topic
Meniscus
Lecture Time
17:00 - 17:09
Session Type
Free Papers
Corresponding Author
Disclosure
Grant research support was provided by Active Impants Inc. No author has any other economic relationship with the company.

Abstract

Purpose

To demonstrate comparative KOOS Overall outcomes of an interpositional knee meniscus endoprosthesis versus non-surgical controls in the treatment of persistent post meniscectomy knee pain.

Methods and Materials

242 patients enrolled in a pooled population, randomized controlled trial (RCT) and single-arm study, comparing the investigational device to non-surgical standard of care. Of the first 100 patients enrolled, whose follow-up has exceeded 12 months, 65 patients were treated with the interpositional endoprosthesis device, and 35 were treated non-surgically. Validated KOOS scores at baseline, 6-week, 6-month, and 12-month time points were obtained from all patients. A “clinically significant improvement” was considered to be an increase of 20 KOOS points, (Roos et al.2003). The cohorts were compared at each time point using a two tailed t-test. All baseline cohort demographics and KOOS Overall score were not statistically different (p>0.05).

Results

Improvement in KOOS Overall for the investigational and control cohorts at 6-months and 12-months were 23.0 and 7.6 points, and 28.8 and 11.3 points, respectively (Figure 1). These data show a statistically significant improvement, above the clinically meaningful threshold, in the investigational arm versus the control arm as early as 6 months (p<0.001) and continues through the 12-month timepoint (p<0.001).

At 12 months, 3 (4.6%) investigational vs. 5 (14.3%) control patients were deemed study failures, due to removal of the investigational device, or due to non-surgical control patients requiring surgical intervention, At 12 months, more patients progressed to knee arthroplasty procedures in the non-surgical, control group (n=4, 11.4%) than in the surgical, investigational group (n=1, 1.5%).

Conclusion

These early one year follow-up results of efficacy KOOS Overall score are encouraging. Further study of the clinical outcomes of these patients and their adverse events is ongoing, with long-term results of both the randomized controlled trial and the single-arm study to be reported in the future.

Collapse
Extended Abstract (for invited Faculty only)

13.2.1 - What do Regulatory Bodies Want?

Presentation Number
13.2.1
Lecture Time
07:30 - 07:45
Session Type
Instructional Course
Corresponding Author
Extended Abstract (for invited Faculty only) Others

17.4.1 - The Science: Osteochondral Remodelling Using Aragonite-Based Implants

Presentation Number
17.4.1
Presentation Topic
Others
Lecture Time
13:00 - 13:20
Session Type
Industry Satellite Symposium
Corresponding Author
Podium Presentation Biomaterials and Scaffolds

18.3.4 - Osteotransduction of an aragonite-based scaffold by human bone marrow-derived mesenchymal stem cells

Presentation Number
18.3.4
Presentation Topic
Biomaterials and Scaffolds
Lecture Time
14:42 - 14:51
Session Type
Free Papers
Corresponding Author
Disclosure
E. Kon, Humanitas U, Italy, Consultant, L. Hangody, Hungary, Other-none, K. Zaslav, US, Consultant, D. Robinson, CartiHeal, Employee, N. Altschuler, CartiHeal, Employee, A. Berta, Hungary, Other-none

Abstract

Purpose

Some aragonite-based scaffolds exhibit osteoconductive properties and are considered useful bone repair scaffolds. The purpose of this study was to evaluate the in vitro osteotransductive potential of the bone phase of a novel aragonite-based bi-phasic osteochondral scaffold (Agili-CTM, CartiHeal Ltd.).

Methods and Materials

Adult human bone-marrow derived mesenchymal stem cells (BM-MSCs) grown in osteogenic medium (Lonza Group Ltd., Basel, Switzerland) were assessed. The study was designed to compare the effect of the bone phase of the Agili-C implant, a coral-derived aragonite scaffold on human BM-MSCs compared to cells grown in an optimal differentiation medium without scaffolds. Analyses were performed at several time intervals: 3, 7, 14, 21, 28- and 42-days post-seeding. Osteogenic differentiation was assessed by morphological characterisation using light microscopy after Alizarin red and von Kossa staining, and scanning electron microscopy. The transcript levels of alkaline phosphatase (ALP), runt-related transcription factor 2 (RUNX2), bone gamma-carboxyglutamate (BGLAP), osteonectin (SPARC) and osteopontin (SPP1) were determined by quantitative PCR. Proliferation was assessed.

Results

Cell cultures of human BM-MSC's demonstrate that the bone phase of the bi-phasic aragonite-based scaffold supports bone formation through enhanced proliferation and osteogenic differentiation of BM-MSCs at both the molecular and histological levels. The scaffold was colonized by differentiating MSCs, suggesting its suitability for incorporation into bone voids to accelerate bone healing, remodelling and regeneration. The mechanism of direct bone formation involves scaffold surface modification with de novo production of calcium phosphate deposits, as revealed by energy dispersive spectroscopy analyses. Scanning the scaffold surface revealed the presence of a microstructure deposit exhibiting a unique morphology (Figure 1) supporting cell attachment (Figure 2).


abstract 4 - figure 1.jpgabstract 4 figure 2.jpg

Conclusion

This implant may promote a fast growth of high-quality bone during the repair of osteochondral lesions. The implant seemed to enhance proliferation of MSCs and formation of multilayer cultures onto its surface.

Collapse

Meeting Participant of

Lord Byron - ICRS Meeting Room (20) ICRS Committee Meeting

Executive Board (Actual Board)

Session Type
ICRS Committee Meeting
Date
05.10.2019
Time
08:45 - 10:00
Location
Lord Byron - ICRS Meeting Room (20)
Lord Byron - ICRS Meeting Room (20) ICRS Committee Meeting

Cartilage GmbH Meeting

Session Type
ICRS Committee Meeting
Date
06.10.2019
Time
08:00 - 08:15
Location
Lord Byron - ICRS Meeting Room (20)
Lord Byron - ICRS Meeting Room (20) ICRS Committee Meeting

Finance Committee

Session Type
ICRS Committee Meeting
Date
05.10.2019
Time
12:15 - 13:00
Location
Lord Byron - ICRS Meeting Room (20)
Lord Byron - ICRS Meeting Room (20) ICRS Committee Meeting

ICRS Diamond Partners

Session Type
ICRS Committee Meeting
Date
07.10.2019
Time
11:00 - 12:00
Location
Lord Byron - ICRS Meeting Room (20)