Sports medicine & Regenerative Surgery

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EARLY STAGE INTERVENTION APPROACHES IN ORTHOPEDYDICS AND SPORT MEDICINE

The medical technology progress in sports medicine and regenerative surgery have led to a decade-old paradigm shift in orthopaedics- instead of palliative therapy and waiting for total joint replacement-early treatment and preservation of functional integrity of the affected joints. Early treatment technologies prevent disabling of the patients and add 10-20 years of active life.

Advanced technology therapy is an alternative to total joint prosthesis and is designed for young patients who want to maintain their active lifestyle and where total joint arthroplasty has a less favourable prognosis. These products have accumulated many years of experience and have been the subject of extensive medical research.

Treatment with these products is indicated in young patients under 60-65 years of age who want to maintain their sport / active lifestyle. Treated with new technological products, patients can for example lift weight, run, play football, and so on, whereas in the case of total joint arthroplasty this is impossible - the whole joint is damaged. For example, "resurfacing technique" is an organ preservative approach - there is a follow-up in patients with 15-year survival of the prosthesis. Most physiological products are second-generation products of the so-called "inlay" prostheses - they completely copy the surface of the joints. Unlike first generation prosthesis or the “on-lay prosthesis” modern resurfacing inlay prosthesis do not affect soft tissues. Implants produced by this technology only allow the damaged part of the joint to recover without altering the natural anatomy of joints and soft tissues or limiting movement.

In addition to maintaining an active lifestyle, the use of modern high-tech products provides the following benefits to patients:
  • Short time of surgery
  • Minor blood loss during surgery
  • Quick recovery of patients and short hospital stay
  • A short rehabilitation time
  • Fast return to an active lifestyle
  • A small percentage of revision operations

ORTEQ Actifit®

ORTEQ Actifit®

Left untreated the meniscus tear, can lead to articular cartilage damage, the onset of osteoarthritis and eventually a total knee replacement. After implantation of Actifit® the damaged meniscal tissue heals.

A meniscus tear is normally repaired by the removal of the torn or damaged tissue via a partial meniscectomy. This can be effective in the short term but often it only gives temporary pain relief. In many cases the pain returns in time due to the loss of meniscal tissue and the cushioning function provided by a healthy meniscus. Over a longer period there is overwhelming evidence that degenerative changes occur, which, if left untreated, can lead to articular cartilage damage, the onset of osteoarthritis and eventually a total knee replacement.
 In such cases helps the  product Actifit®. Actifit® is implanted via arthroscopic surgery into the meniscal defect and as the damaged meniscal tissue heals Actifit® gradually dissolves and is removed naturally from the body.
Actifit® is a honeycomb scaffold that enables blood to flow through it and provide an anchor for new cellular in-growth as the body’s natural healing process takes place. Once the damaged section of the meniscus has been cut away and the meniscus resected to an area with good blood supply, the Actifit® implant is cut to size and stitched into place. Over time, the new cellular in-growth matures into new meniscus like tissue. This will help restore the cushioning function of the meniscus and delay the onset of osteoarthritis.

ARTHROSURFACE HemiCap® & UniCAp®

ARTHROSURFACE HemiCap® & UniCAp®

An amazing opportunity for adults in active age (35-65).They can avoid total joint transplantations and if eligible they could go for “resurfacing” with HemiCAP®  or  UniCAP® “ïnlay” inplants and thus continuing their active life style-including doing sport.

What is partial or so-called focal prosthesis, and why it is an alternative to the total joint prosthesis?

Ten years ago, Arthrosurface® USA, for the first time, proposed focal implants under the tradename HemiCAP® and UniCAP®. They are based on the so-called “resurfacing” and “inlay” technology.
Implants produced by this technology allow only the damaged part of the joint to recover, without changing the natural anatomy of the joints and joints tissues and thus limiting the movement. With HemiCAP® and UniCAP® implant systems, significantly fewer bones and tissues are removed (compared to total joint prost After that, the operative patient returns to the active (sports) lifestyle.
The technology for these systems is based on innovative three-dimensional mapping so that the implant fully covers the size and shape of the defect in accordance with the patient's natural anatomy. The technology has been shifted from lens manufacturing (three dimensional copying to the surface) and also resembles a reconstruction of tooth defect - anatomical copying of healthy tissues and organs.
The HemiCAP® and UniCAP® Implantable Implant Systems are minimally invasive and organs-preserving and are suitable for patients aged between 38 and 60 years. They can be defined as intermediate treatment of joint defects – between conservative therapy (for example, physical treatment, pain management) and biological treatment (e.g. microfracture or others) on the one hand, and conventional total joint replacement on the other hand.

Which are the right patients for HemiCAP® and UniCAP® Resurfacing Implant Systems?

  • Patients with severe and debilitating pain
  • Patients resistant to conservative treatment
  • Patients unsuitable for total joint prosthesis - middle age with an active lifestyle

What are HemiCAP® and UniCAP® Resurfacing Implant Systems?

Implant systems consist of three elements:

  • An articular resurfacing component of cobalt-chromium alloy with titanium, which is measured and personalized for the patient
  • Cancellous screw fixation
  • A set of instruments that allows the surgeon to accurately and three-dimensionally measure the defect and use the appropriate implant.
    The implant is made of cobalt-chromium alloy with titanium, a material that has been proven in general arthroplasty for decades. The fixing component resembles a bolt and is made of titanium. This material has also been successfully used in general arthroplasty for decades. The articular resurfacing component and the cancellous screw fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

For which joints HemiCAP® and UniCAP® Resurfacing Implant Systems are available for joint preservation?

Resurfacing implant systems are available for shoulder, hip, knee, including PFJ, foot-ankle, and metatarsal joints. In Bulgaria, NHIF partially covers only knee and PF implant systems.
Because the treatment costs for total joint replacement and resurfacing implant systems do not significantly differs, the patient and the doctor should discuss the suitability of such a treatment: e.g. the size of the defect; joint and joint apparatus status, general health condition, age and lifestyle and, last but not least, the experience of the treating physician with joint preservation technology

Key Facts about HemiCAP® and UniCAP® Resurfacing Implant Systems:

HemiCAP® and UniCAP® joint preservation technology has been developed for the so-called "millennium" patients - who, due to increased life expectancy, want to stay at their job longer and prefer an active lifestyle.
Joint preservation technology is suitable for patients who realize the need to maintain joint mobility.
Resurfacing implants are a stand-alone treatment option that covers the gap between conservative and biological treatment and total joint arthroplasty.
HemiCAP® and (UniCAP®) resurfacing implant systems restore the joint defect while maintaining the remaining joint structures unaffected.
The natural biomechanics of the joint are retained, allowing patients to maintain their usual movements and activities
Clinical tracking at over 60,000 implants worldwide shows positive results in all HemiCAP® (UniCAP®) joint implants (shoulder, hip, knee, foot)
In the multi-center studies conducted, patients reported a change in pain; for a short rehabilitation period and a significant improvement in the volume of movement.
The operations of some articular implants may be performed under outpatient conditions.


ARTHROSURFACE NanoFix®

ARTHROSURFACE NanoFix®

For patients who have the beginning stages of arthritis or cartilage damage, NanoFx® is a preliminary treatment for pain relief

NanoFx® (Nanofracture) is a device for marrow stimulation that provides a better solution than a standard microfracture technique. In this Nanofracture procedure, a surgeon uses a needle to create holes in the exposed defect that will cause bleeding. This enables new cartilage to develop, which will grow and fill the lesion to create a new surface. This response is similar to the healing process of a “scar” or the way a scab grows over a cut. The NanoFx® procedure has been proven to create smaller and deeper cell channels than a standard microfracture technique, therefore stimulating more bone marrow and achieving better results.
The NanoFx® (Nanofracture) offers a “Smaller, Deeper, Better” solution compared to a standard microfracture procedure. The instruments consist of a reusable Hand Instrument and a single use disposable PleuriStik™ for performing a microfracture procedure for the treatment of small localized articular cartilage defect sites. The 1mm PleuriStik™ disrupts less surface area than a standard microfracture technique and it was purposefully designed to reduce damage to the subchondral plate. It penetrates down to a standardized 9mm depth to reach the targeted marrow cells, three times deeper than comparable microfracture techniques. When tested against an awl or k-wire, NanoFx® resulted in thin, fragmented cancellous bone channels without rotational heat generation. It also demonstrated deep cancellous bone perforation with a higher number of open trabecular channels.
The NanoFx® handle is available with a 15° angle and as an A-Curve, which is specifically designed for hard to access Ankle Lesions.

Key Benefits of NanoFx®:

  • Doesn’t damage the underlying bone
  • More holes provides increased marrow flow to the defect site
  • Better tissue quality with pain relief
  • Functional improvement and greater durability
  • Reduced osteophyte formation (bone bumps)
  • Faster recovery (than Microfracture) through decreased trauma to the defect site

MaioRegen®

MaioRegen®

Lesions of the joint surface larger than 2 cm 2, involving cartilage damage and simultaneous suffering of the sub-chondral bone structure are a severe and very common clinical challenge, frequently diagnosed also in young people. If untreated, they may degenerate into chronic, disabling conditions that can be addressed only by an invasive approach.

To guarantee the successful restoration of a healthy and functional joint, we should go “to the core of the problem”.
MaioRegen® is a new therapeutic concept, inspired by nature and shaped by state-of-the-art Nanotechnologies.
It promotes and guides an effective bone and cartilage regeneration, thus restoring the natural joint physiology.
MaioRegen® is obtained through a unique, patented process, the result of the cooperation between Finceramica® and internationally recognized research centres.

What it is MaioRegen®?

MaioRegen® is a three-dimensional matrix which mimics the entire osteo-cartilaginous tissue: cartilage, tide-mark and sub-chondral bone. It is a monolithic, multi-layer scaffold:
the superficial layer consists of deantigenated type I equine collagen and resembles the cartilaginous tissue,
 while the lower layer consists mostly of magnesium-enriched hydroxyapatite (Mg-HA), and simulates the sub-chondral bone structure.
The intermediate layer, composed of Mg-HA and collagen, reproduces the tide-mark.

How does MaioRegen® work?

 It provides a biomimetic osteochondral scaffold which guides and promotes bone and cartilage tissue restoration by inducing selective differentiation of the body’s own bone marrow or synovial fluid derived progenitor cells into osteocytes, in the sub-chondral layer and chondrocytes in the cartilage layer.The experimental study results show how MaioRegen®, once implanted, is able to integrate with surrounding tissues and guarantee the regeneration of the entire damaged osteo-chondral tissue, with the formation of well-structured bone tissue and hyaline like cartilaginous tissue.
The adhered progenitor cells proliferate, differentiate and synthesize bone and cartilage matrix according to the organic mineral gradient found inside the scaffold. The progressive reabsorption of MaioRegen® and the simultaneous cell mediated remodelling favour the complete regeneration of the osteo-cartilagenous tissue.

When MaioRegen® should be used?

MaioRegen® is indicated in all cases where it is necessary to restore osteo-cartilaginous connective tissue in the joints, in particular in the treatment of:
• osteo-chondral lesions of traumatic, post-traumatic, degenerative origin or due to osteochondritis dissecans;
• III-IV grade lesions (Outerbridge classification);
• focal, single or multiple lesions
MaioRegen® should not be used in patients with advanced osteoarthritic conditions,
immune system disorders, neoplastic diseases, infectious diseases, obesity (BMI > 30) or above 60 years of age.

PARCUS PEEK CF™

PARCUS PEEK CF™Parcus Medical™ is the first to make implantable products using PEEK CF™ for the sports medicine industry. PEEK CF™ is made of PEEK-OPTIMA™ (by Invibio) combined with 30% carbon fiber fill. The compound is comprised of short carbon fibers that are dispersed within a PEEK-OPTIMA polymer matrix. The polymer in PEEK CF™ encapsulates the carbon fibers.

What is Parcus PEEK CF?
Parcus Medical™ is the first to make implantable products using PEEK CF for the sports medicine industry. PEEK CF is made of PEEK-OPTIMA™ (by Invibio) combined with 30% carbon fiber fill. The compound is comprised of short carbon fibers that are dispersed within a PEEK-OPTIMA polymer matrix. The polymer in PEEK CF encapsulates the carbon fibers.
The resulting material has enhanced physical strength (nearly twice as much as natural PEEK) and has mechanical characteristics much closer to cortical bone than natural PEEK, PLLA or titanium. The added mechanical strength in PEEK CF plays a key role in addressing the challenges of insertion torque in screw-in devices such as suture anchors and interference screws.
 
The PEEK CF Difference

•    Radiolucent, less imaging artifact, MR safe
•    Twice as strong as the PEEK material used in other suture anchors
•    Mechanical properties closer to cortical bone than titanium or biocomposites



ASPIRE Marrow Cellution™

ASPIRE Marrow Cellution™

The Marrow Cellution™ Bone Marrow Aspiration & Cancellous Bone Graft Harvesting
System is a novel bone marrow access and retrieval device that incorporates features designed to minimize limitations of traditional trocar needles.
MarrowCellution™Bone Marrow Aspiration System (MC-RAN-11)
overcomes the limitations of a traditional bone marrow needle and results in a bone marrow harvest that is so rich in key stem and progenitor cells that the aspirate may no longer require manipulation through centrifugation prior to application.
MarrowCellution™Bone Marrow Aspiration-&Autologous BoneHarvestingSystem(MC-RAN-8)
The high cellular composition of Marrow Cellution™ Aspirate combined with percutaneously harvested bone dowel(s) deliver autograft without the associated morbidity.
Produces graft material with osteoconductive, osteoinductive & osteogenic properties.
Minimally invasive technique, using 8 gauge trephine needle for bone dowel extraction.
May be combined with allogenic, autologous or synthetic bone chips hydrated with marrow aspirate. 

Marrow Cellution™ accesses aspirate flow collected exclusively laterally as the tip of the aspiration cannula is closed allowing marrow collection perpendicular to and around the channel created by the tip of the device. It incorporates technology to precisely reposition the retrieval cannula within the marrow space after each aspiration. These features achieve a clinicians' desire for a single entry point. A single puncture with Marrow Cellution™ provides high quality bone marrow aspirate and bone graft, collected from numerous sites within the marrow geography. Marrow Cellution™ provides substantial savings of effort, time and expense. It reduces patient trauma, morbidity and risk of infection
Marrow Cellution™ maximizes stem and progenitor cell recovery and minimizes peripheral blood infiltration. Trocar needles with side ports aspirate primarily through an open-ended cannula. This leads to excess blood collection, requiring additional manipulation, i.e. centrifugation or chemical separation in a laboratory.
In addition, because there is reduced peripheral blood infiltration in bone marrow harvesting, Marrow Cellution allows the clinician to keep the product entirely on the sterile field rather than requiring the product the leave the sterile field for centrifugation and re-enter the sterile field for administration in the patient, reduces time for the final product to be delivered to the patient (no centrifugation necessary), reduces procedural expenses, and retains all the cells and growth factors obtained in the aspiration.
Use of centrifuged bone marrow aspirate for regenerative medicine is a growing practice; however, such centrifugation systems require aspirating large volumes (30-240 mL) in order to obtain sufficient stem/progenitor cellularity in a large enough post-centrifugation final volume for therapeutic administration. It is well known that the highest quality (highest quantity of stem/progenitor cells) bone marrow aspirations require aspirating small volumes of bone marrow (1-2 mL).
The need for centrifugation, and consequent volume reduction, is due to the limitations of the traditional bone marrow aspiration needle. Blood and marrow are non-Newtonian fluids and the traditional needle has a large open port at its distal end; as such, it is known that peripheral blood infiltrates bone marrow aspirates greater than 1-2 mL. Marrow Cellution™ (Ranfac, Avon, MA), a novel bone marrow access and retrieval device requires substantially less bone marrow aspirate, the limitations of standard bone marrow aspiration needles (e.g., reduced stem/progenitors cell concentrations due to dilution with peripheral blood) are substantially overcome. Further, the single step Marrow Cellution™ produced the same (as counted by CD34+ cells) or greater (as counted by fibroblast-like colony-forming units, CFU-f) stem/progenitor cell concentrations as a combination of traditional needles and centrifugation with the SmartPReP2 Bone Marrow Aspirate Concentrate (BMAC) centrifuge-based 2 cellular processing system (Harvest Technologies, Plymouth, MA).
Marrow Cellution™ achieves multiple small volumes of high quality bone marrow aspirate collected from various sites distributed within the marrow cavity.
A single puncture with Marrow Cellution™ is functionally equivalent to repeated puncture sites with a traditional trocar needle collecting small aspirate volumes, but with substantial savings of time, effort, reduced patient trauma, morbidity and risk of infection.

CFU-f
There is no constant ratio between average marrow cellularity as measured by number of total nucleated cells per mL and the number of CFU-f. Hernigou et al in several authoritative studies linked clinical outcomes in non-union and osteonecrosis to the number of CFU-f cells in the graft.
Controlling for volume, Hernigou et. al. noted that 70% of the variation in CFU-f from patient to patient was due to variations in the quality of the marrow aspirate or idiosyncratic to the patient with the remaining variation being due to the of number of nucleated cells per mL in the aspirate.
Statistically, the only variable Hernigou reported to be significant was CFU-f and not nucleated cells per mL. Interestingly, CFU-f is found frequently in marrow and very rarely in peripheral blood.
“Therefore, it seems reasonable to suggest that a graft needs to contain greater than 1000 progenitors/cm3” (P. Hernigou).

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