A. Gomoll (New York, US)

Hospital for Special Surgery

Presenter Of 4 Presentations

Podium Presentation Osteoarthritis

16.1.2 - Amniotic Suspension Allograft (ASA) for Treatment of Knee Osteoarthritis in a Randomized Controlled Multi-Center Trial

Presentation Number
16.1.2
Presentation Topic
Osteoarthritis
Lecture Time
11:24 - 11:33
Session Name
Session Type
Free Paper Session
Corresponding Author
Disclosure
J.Farr, Organogenesis, Consultancy, Royalties, Research Support; A.Gomoll, Organogenesis, Consultancy, Royalties, Research Support; K.Kimmerling, Organogenesis, Employee; K.Mowry, Organogenesis, Employee. This study was supported by Organogenesis.

Abstract

Purpose

A pilot study using a single injection of amniotic suspension allograft (ASA) for the treatment of OA demonstrated safety and trends for improved pain and function. To further investigate these effects, a multi-center randomized controlled trial was designed to evaluate the efficacy of ASA injection for the treatment of knee OA symptoms.

Methods and Materials

200 blinded patients were randomized (across 12 sites) 1:1:1 to: saline, HA, or ASA. Patient reported outcomes (PROs) were completed at baseline and up to 1-year following injection. Changes in Visual Analog Scale (VAS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) PROs from baseline were used to assess efficacy of the injections. Efficacy analysis consisted of ANCOVA in the PROC GLM of the change from baseline between treatment group means where the baseline was included as the covariate at 6 and 12 months.

Results

Patients receiving ASA had significantly lower VAS joint pain scores compared to both HA and saline (p<0.01) at 6 and 12 months. For the KOOS pain subscale, patients receiving ASA had significantly better scores compared to both HA and saline (p<0.05) at 6 and 12 months. ASA treatment resulted in significantly better KOOS symptom scores compared to both HA and saline at 6 and 12 months (p<0.01). For KOOS activities of daily living, ASA treatment resulted in significant increases compared to both HA and saline (p<0.01, p<0.05) at 6 and 12 months. Sports and recreation (S&R) and quality of life (QOL) KOOS subscales resulted in significantly higher scores at 6 months compared to HA (S&R p<0.05; QOL p<0.01) and significantly greater higher scores than HA and saline at 12 months (S&R p<0.05; QOL <0.001).

Conclusion

In this 200-patient clinical trial, subjects receiving ASA treatment showed greater improvement compared to HA and saline, providing evidence for the use of ASA to treat OA symptoms.

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Podium Presentation Allografts

16.3.6 - Rescue Injection of Amniotic Suspension Allograft Improves Pain and Function in Patients with Knee Osteoarthritis

Presentation Number
16.3.6
Presentation Topic
Allografts
Lecture Time
12:00 - 12:09
Session Type
Free Paper Session
Corresponding Author
Disclosure
A.Gomoll, Organogenesis, consulting, royalty, research support J.Farr, Organogenesis, consulting, royalty, research support K.Mowry, Organogenesis, Employee K.Kimmerling, Organogenesis, Employee

Abstract

Purpose

Osteoarthritis (OA) affects 30.8 million Americans; over 54% of these patients are estimated to require joint replacement during their lifetime. A multi-center randomized trial was conducted to investigate the effects of amniotic suspension allograft (ASA) in comparison to saline and hyaluronic acid (HA). Within this study there was an option for rescue if there was inadequate pain relief with the index injection. The purpose of the current study was to examine the effects of rescue injections compared to the patient’s initial treatment.

Methods and Materials

200 patients from 12 sites were randomized 1:1:1 to either saline, HA, or ASA. Patients (blinded) received a single intra-articular injection and were followed for 12 months. At 3 months, patients who self-reported unacceptable pain were eligible to receive ASA (if their initial randomization was saline or HA). ASA patients who reported unacceptable pain were offered standard of care management (outside of the study). Rescued patients (n=94) were followed from rescue (new baseline) to 12 months post-rescue. Changes from baseline to 3 months follow-up (original) were compared to changes from rescue baseline to the 3-month rescue visit using Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS). Statistical comparisons were made using LSMEANS with p-values from PROC MIXED.

Results

Patients who were rescued with ASA had significantly greater improvements in KOOS pain scores (original Δ 4.62, rescue Δ 12.29; p=0.0044) and ADL scores (original Δ 5.55, rescue Δ 10.94; p=0.0432) compared to their original treatment course (saline or HA). Furthermore, rescued patients had significantly greater improvements in VAS pain with a rescue injection (original Δ -9.44, rescue Δ -27.26; p=0.0064).

Conclusion

Patients who received a rescue injection of ASA showed significantly greater improvements compared to their initial treatment. This data provides evidence for the potential use of ASA in the treatment of knee OA symptoms.

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Podium Presentation Osteoarthritis

18.4.8 - Effect of the Atlas™ Unicompartmental Knee System on Tibiofemoral Joint Stress During the Stance Phase of Gait

Presentation Number
18.4.8
Presentation Topic
Osteoarthritis
Lecture Time
15:18 - 15:27
Session Type
Free Paper Session
Corresponding Author
Disclosure
A.Gomoll, Moximed, Consultant, Royalties. Moximed sponsored the study and they manufacturer the Atlas

Abstract

Purpose

The Atlas™ system (Moximed Inc.) is a novel implant designed to bridge the treatment gap for medial osteoarthritis between conservative care and joint replacement. The device is placed subcutaneously without violating the joint capsule. A polymer absorber provides an opposing force of up to 142 N to reduce medial compartment loads during weight-bearing. Slynarski observed improved pain and function in patients with medial knee OA. Our aim was to investigate the underlying biomechanical responses to further elucidate the mechanism of action.

Methods and Materials

A CAD model of the Atlas™ was virtually implanted in a validated finite element model based on a 3T MRI of a cadaveric knee. The ideal placement of the femoral and tibial components engaged the absorber during weight-bearing flexion (i.e. <30°) and disengaged the absorber during non-weight-bearing flexion (i.e. >30°). Forces and moments from gait analysis of an anthropometrically matched male were used to drive the model at each sagittal knee angle. Multiple quasi-static simulations were used to analyse the different time-points during stance.

Results

Results were computed as peak values within tibial and femoral cartilage (C-C), and tibial cartilage and meniscus (C-M) contact regions. Medial mean C-C stress reduced by 0.6 ± 0.7 MPa (-45%) while C-M stress reduced by 0.5 ± 0.5 MPa (-46%). Lateral mean C-C stress changed by 0.2 ± 0.3 MPa (-18%), C-M stress remained relatively unchanged (-8%). (Figure 1)

table 1.jpg

Conclusion

The model demonstrated reduced stress in both medial and lateral compartments, supporting the device's efficacy for unloading the medial tibiofemoral joint, which is consistent with the available clinical data. As medial compartment unloading was not accompanied with an increase in loading of the lateral compartment, we may conclude that the Atlas™ works by sharing as opposed to transferring load. From a biomechanical view, internal joint unloading may work as a treatment for patients unresponsive to conservative care.

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Extended Abstract (for invited Faculty only) Cartilage /Cell Transplantation

22.0.2 - ACL Isolated Cartilage Lesion – Treat

Presentation Number
22.0.2
Presentation Topic
Cartilage /Cell Transplantation
Lecture Time
09:05 - 09:10
Session Type
Plenary Session
Corresponding Author

Moderator Of 2 Sessions

Regency Plenary Session
Session Type
Plenary Session
Date
07.10.2019
Time
08:30 - 09:30
Location
Regency
Plaza A Industry Satellite Symposium
Session Type
Industry Satellite Symposium
Date
07.10.2019
Time
13:00 - 14:00
Location
Plaza A