A. Gomoll (New York, US)Hospital for Special Surgery
Presenter Of 4 Presentations
16.1.2 - Amniotic Suspension Allograft (ASA) for Treatment of Knee Osteoarthritis in a Randomized Controlled Multi-Center Trial
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.
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).
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.
16.3.6 - Rescue Injection of Amniotic Suspension Allograft Improves Pain and Function in Patients with Knee Osteoarthritis
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.
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).
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.
18.4.8 - Effect of the Atlas™ Unicompartmental Knee System on Tibiofemoral Joint Stress During the Stance Phase of Gait
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 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)
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.
22.0.2 - ACL Isolated Cartilage Lesion – Treat
Moderator Of 2 Sessions
Meeting Participant of
General Board (Actual Board)
- A. Gobbi (Milano, IT)
- K. Zaslav (Richmond, US)
- E. Kon (Milano, IT)
- C. Lattermann (Boston, US)
- D. Grande (Manhasset, US)
- T. Minas (West Palm Beach, US)
- M. Brittberg (Kungsbacka, SE)
- L. Biant (Manchester, GB)
- B. Cole (Chicago, US)
- R. Decker (San Diego, US)
- A. Getgood (London, CA)
- A. Gomoll (New York, US)
- M. Hurtig (Guelph, CA)
- J. Lane (La Jolla, US)
- B. Mandelbaum (Santa Monica, US)
- S. Marlovits (Vienna, AT)
- R. McCormack (New Westminster, CA)
- S. Nehrer (Krems, AT)
- E. Papacostas (Kalamaria, Thessaloniki, GR)
- S. Sherman (Palo Alto, US)
- L. Vonk (Utrecht, NL)
- W. Bugbee (La Jolla, US)