HYALOFAST®

Unlike other multi-layered collagen or synthetic products, HYALOFAST® is composed of a single 3D fibrous layer of HYAFF®, a benzyl ester of hyaluronic acid (HA), which is a natural component of the extracellular matrix and a major component of human cartilage.
Once implanted, its non-woven 3D structure supports MSC adhesion and 3D organization, facilitating the recovery of the normal tissue anatomy. As the HYAFF fibres degrade, HA is released into the lesion creating a micro-environment favorable to regeneration.

HyaloFast carries the CE mark for the derivation of mesenchymal stem cells for the treatment of chondral and osteochondral lesions.

STANDARDIZED PROCESS

Controlled depth of 9 mm, narrow diameter of 1 mm and reusable instrument with sharp disposable needle

ABOVE BONE MARROW STIMULATION

Increased stem cell yield due to deeper perforation and better defect filling with high collagen type 2 content

SIMPLE AND SAFE APPLICATION

Smooth and fast perforation and facilitates the restoration of the subchondral bone

Application

Step 1:
Insert the PleuriStik needle, tip down, through the opening of the Thumb Tab and through the proximal opening of the NanoFX® guide without the needle being visible at the distal tip of the guide.

Step 2:
Place the tip of the NanoFx® Guide 2-3 mm in front of the intact cartilage wall away into the defect. Place the tip of the NanoFX® Guide only lightly on the subchondral plate.

Step 3:
Lightly tap the exposed proximal tip of the needle several times with a hammer to insert the needle into the defect to the depth limit of 9mm.

Step 4:
To retract the needle one-handed, press down on the thumb tab with your thumb. This will lever the PleuriStik needle out of the NanoFx® Guide. To perform additional perforations, reposition the guide and repeat steps 2-4.
The NanoFx® Guide is reusable and must be cleaned and sterilized after use.

STUDY CONCLUSION

Spherox has been shown to improve patients’ symptoms and knee function in two studies in adults between 18 and 50 years of age. The main measure of effectiveness was the KOOS (knee injury and osteoarthritis outcome score), which is graded on a scale from 0 to 100 (where 0 means severest symptoms and 100 means no symptoms). The KOOS was self-measured by patients, who rated the severity of their symptoms such as pain, impact on daily living, sport and recreational activities, and quality of life.

In the first study involving 100 adults, Spherox was compared with microfracture (a type of surgery used to treat defects in cartilage). The knee cartilage defects were between 1 and 4 cm2 in size. Data from this study showed that Spherox improved the outcome score by 22 points to 28 points until 5 years after treatment and was as effective as microfracture.

The second study looked at 73 adults with large cartilage defects of the knee from 4 to 10 cm². All these patients received treatment with Spherox, as microfracture is not recommended to repair such large defects. In this study, patients’ outcome scores with Spherox improved by 16 points in the first year and further improvements were seen up to three years after treatment and remained stable until five years after treatment.

A third study looked at the treatment effect with Spherox in 105 adolescents aged between 15 and 17 years with cartilage defects of the knee joint. Overall, the results indicated that there was no major difference in terms of effectiveness between the adolescents included in this study and the young adults (from 18 to 34 years of age) who participated in the previous two studies.

Literature:

1. Kreuz PC, Steinwachs MR, Erggelet C, Krause SJ, Konrad G, Uhl M, Südkamp N. Results after microfracture of full-thickness chondral defects in different compartments in the knee. Osteoarthritis Cartilage. 2006 Nov;14(11):1119-25.

2. Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20.

3. Steadman JR, Briggs KK, Rodrigo JJ, Kocher MS, Gill TJ, Rodkey WG. Outcomes of microfracture for traumatic chondral defects of the knee: average 11-year follow-up. Arthroscopy. 2003 May-Jun;19(5):477-84.

4. Chen H, Sun J, Hoemann CD, Lascau-Coman V, Ouyang W, McKee MD, Shive MS, Buschmann MD. Drilling and microfracture lead to different bone structure and necrosis during bone-marrow stimulation for cartilage repair. J Orthop Res. 2009 Nov;27(11):1432-8.

5. Chen H, Hoemann CD, Sun J, Chevrier A, McKee MD, Shive MS, Hurtig M, Buschmann MD. Depth of subchondral perforation influences the outcome of bone marrow stimulation cartilage repair. J Orthop Res. 2011 Aug;29(8):1178-84.

6. Fortier LA, Cole BJ, McIlwraith CW. Science and animal models of marrow stimulation for cartilage repair. J Knee Surg. 2012 Mar;25(1):3-8.

7. Eldracher M. et al. Small Subchondral Drill Holes improve Marrow Stimulation of Articular Cartilage Defects. Am J Sports Med. 2014 Nov;42(11):2741-50.

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