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Global Regenerative Trade

MAGELLAN®

REGENERATIVE ORTHOPEDICS

WHAT IS REGENERATIVE MEDICINE?

Regenerative Medicine encompasses many medical fields – Orthopedics and Spine Surgery, Sports Medicine, Gynecology, Urology, Oncology, Dermatology, Plastic surgery, Vascular Surgery, Cardiac surgery, etc.

Regenerative Medicine is the branch of medicine that develops methods to regrow, repair or replace damaged or diseased cells, organs or tissues. Regenerative medicine includes the generation and use of therapeutic stem cells, tissue engineering and the production of artificial organs. It uses autologous blood, bone marrow or adipose components to stimulate the body’s own repair processes. A common source for regenerative cells and growth factors are bone marrow aspirate concentrate (BMAC), platelet rich plasma (obtained from one’s own blood) and adipose derived stem cells.

PATHOLOGY

CHRONIC ACHILLES TENDON INJURY

The Achilles tendon is the strongest tendon in the body, linking the heel bone to the calf muscle. Problems with the Achilles are some of the most common conditions seen by sports medicine doctors. Chronic, long-lasting Achilles tendon disorders can range from overuse injuries to tearing of the tendon. Pain in the heel is often caused by a combination of both acute and chronic problems, including inflammation (paratenonitis, insertional tendonitis and retrocalcaneal bursitis) and tendinosis.

Achilles tendon inflammation injuries

What is paratenonitis?

Paratenonitis is an acute Achilles injury caused by overuse. It involves inflammation of the covering of the Achilles tendon. “In really acute cases, the tendon can appear sausage-like, because it is so severely swollen,” says Russell Warren, MD, a sports medicine orthopedic surgeon at Hospital for Special Surgery in New York. Marathon runners often experience this type of swelling after long runs. Runners may complain of stiffness and discomfort at the beginning of the run, but push through the discomfort. Symptoms are typically aggravated by running and relieved by rest. If left untreated, paratenonitis may progress to the point that any running becomes difficult.

What is insertional tendonitis?

Insertional tendonitis involves inflammation at the point where the Achilles tendon inserts into the heel bone. People with this condition often have tenderness directly over the insertion of the Achilles tendon, which is commonly associated with calcium formation or a bone spur forming just above the insertion point. This condition can occur along with retrocalcaneal bursitis (see below) and a bony enlargement of the heel bone, known as Haglund’s deformity (someimtes is referred to as a “pump bump”). “Most cases of Haglund’s deformity occur in women who wear high-heeled shoes or men and women hockey players because of the skate rubbing on the back of the heel,” says Scott Rodeo, MD, a sports medicine orthopedic surgeon at Hospital for Special Surgery.

What is retrocalcaneal bursitis?

Retrocalcaneal bursitis is caused by movement-related irritation of the retrocalcaneal bursa, the fluid-filled cushioning sac between the heel bone and the Achilles tendon. This condition involves pain in front of the Achilles tendon, in the area between the tendon and the heel bone. The bursa can become inflamed or thickened and stick to the tendon, as a result of overuse or repetitive loading. Pain may result from squeezing the tendon itself or the space just in front of the tendon. “Although retrocalcaneal bursitis can be associated with rheumatoid arthritis in 10 percent of people, most occurrences in athletes only involve one side and are not associated with a systemic disease,” says Dr. Warren.

 

 

GONARTHROSIS

Gonarthrosis is most frequently defined as changes involving articular cartilage damage, abnormal bone formation, reactive changes in synovial membrane and pathologic synovial fluid. The site of initial damage remains unknown. It is known presently that in the development of the process, reparative reaction of chondrocytes expressed by increase of synthesis of the main collagen types (type II, in lower degree types IX, VI, XI) and also of proteoglycans, is the primary event, at cell level. The final result of the pathological process in gonarthrosis is imbalance between synthesis of articular cartilage and damage leading to its loss. Each cause or process inducing cartilage degradation exerts effects on the occurrence and progression of gonarthrosis.

Gonarthrosis is diagnosed on the basis of clinical and radiological examinations. Magnetic resonance, bone scintigraphy and arthroscopy are also of importance. However, in the future, the markers of articular cartilage destruction products in body fluids would be the key to determination of the time of the onset of the disease, its progression and advances of treatment. Great hopes in the treatment of gonarthrosis could be connected with BMAC therapy.

FRACTURE NON-UNIONS

Nonunion is permanent failure of healing following a broken bone unless intervention (such as surgery) is performed. A fracture with nonunion generally forms a structural resemblance to a fibrous joint, and is therefore often called a “false joint” or pseudoarthrosis (the Greek stem “pseudo-” means false and “arthrosis” means joint). The diagnosis is generally made when there is no healing between two sets of medical imaging such as X-ray or CT scan. This is generally after 6–8 months.

Nonunion is a serious complication of a fracture and may occur when the fracture moves too much, has a poor blood supply or gets infected. Patients who smoke have a higher incidence of nonunion. The normal process of bone healing is interrupted or stalled.

Since the process of bone healing is quite variable, a nonunion may go on to heal without intervention in a very few cases. In general, if a nonunion is still evident at 6 months post injury it will remain unhealed without specific treatment, usually orthopedic surgery. A non-union which does go on to heal is called a delayed union.

BIMALLEOLAR FRACTURES

bimalleolar fracture is a fracture of the ankle that involves the lateral malleolus and the medial malleolus. Studies have shown that bimalleolar fractures are more common in women, people over 60 years of age, and patients with existing comorbidities.

Bimalleolar fractures can cause severe pain, swelling, and bruising in the injured ankle. They also can be tender to the touch and make walking or putting any weight on the affected foot very difficult and painful.

 

ROTATOR CUFF TENDINITIS

Rotator cuff tendinitis, or tendonitis, affects the tendons and muscles that help move your shoulder joint. If you have tendinitis, it means that your tendons are inflamed or irritated. Rotator cuff tendinitis is also called impingement syndrome.

This condition usually occurs over time. It can be the result of keeping your shoulder in one position for a while, sleeping on your shoulder every night, or participating in activities that require lifting your arm over your head.

Athletes playing sports that require lifting their arm over their head commonly develop rotator cuff tendinitis. This is why the condition may also be referred to as:

  • swimmer’s shoulder
  • pitcher’s shoulder
  • tennis shoulder

Sometimes rotator cuff tendinitis can occur without any known cause. Most people with rotator cuff tendinitis are able to regain full function of the shoulder without any pain.

The symptoms of rotator cuff tendinitis tend to get worse over time. Initial symptoms may be relieved with rest, but the symptoms can later become constant. Symptoms that go past the elbow usually indicate another problem.

Symptoms of rotator cuff tendinitis include:

  • pain and swelling in the front of your shoulder and side of your arm
  • pain triggered by raising or lowering your arm
  • a clicking sound when raising your arm
  • stiffness
  • pain that causes you to wake from sleep
  • pain when reaching behind your back
  • a loss of mobility and strength in the affected arm

ACL INJURY

An ACL injury is a tear or sprain of the anterior cruciate (KROO-she-ate) ligament (ACL) — one of the major ligaments in your knee. ACL injuries most commonly occur during sports that involve sudden stops or changes in direction, jumping and landing — such as soccer, basketball, football and downhill skiing.

 

Many people hear or feel a “pop” in the knee when an ACL injury occurs. Your knee may swell, feel unstable and become too painful to bear weight.

Depending on the severity of your ACL injury, treatment may include rest and rehabilitation exercises to help you regain strength and stability or surgery to replace the torn ligament followed by rehabilitation. A proper training program may help reduce the risk of an ACL injury.

Symptoms

Signs and symptoms of an ACL injury usually include:

  • A loud “pop” or a “popping” sensation in the knee
  • Severe pain and inability to continue activity
  • Rapid swelling
  • Loss of range of motion
  • A feeling of instability or “giving way” with weight bearing

When to see a doctor

Seek immediate care if any injury to your knee causes signs or symptoms of an ACL injury. The knee joint is a complex structure of bones, ligaments, tendons and other tissues that work together. It’s important to get a prompt and accurate diagnosis to determine the severity of the injury and get proper treatment.

COXARTHROSIS

The hip is the joint between the pelvis and the femur, and hip osteoarthritis is the wear and tear of the cartilage rubbing between these two bones. This wear causes joint inflammation resulting in pain and discomfort, which worsen as the disease progresses: the bone under the damaged cartilage grows forming bone spurs (osteophytes) around the joint.

Pain is generally one of the first signs in the diagnosis of hip osteoarthritis, or coxarthrosis. This pain can be felt in the groin, and sometimes the buttock or the back of the thigh. Knee pain can also point to this diagnosis, which will of course be confirmed by an x-ray. Joint pain, functional impairment and limping will progressively worsen, except in rare cases of “rapidly destructive” coxarthrosis for which the progression is very fast. Hip osteoarthritis is a serious disease that becomes rapidly incapacitating as it affects a weight-bearing joint.

Medical treatment of hip osteoarthritis

At the first symptoms of hip osteoarthritis, a healthy lifestyle (healthy weight, appropriate, low-impact physical activities) is necessary to limit the pain and stop the disease worsening. Sports such as swimming are therefore highly recommended. During flare-ups, paracetamol or any non-steroidal anti-inflammatories can be used to help relieve the pain.

When these treatments are no longer effective, corticosteroid injections, hyaluronic acid viscosupplementation, or platelet rich plasma therapy (PRP) can be envisaged. Stem cell injections can also be discussed.

OSTEOCHONDRAL LESIONS

Osteochondral lesions or osteochondritis dessicans can occur in any joint, but are most common in the knee and ankle. Such lesions are a tear or fracture in the cartilage covering one of the bones in a joint. The cartilage can be torn, crushed or damaged and, in rare cases, a cyst can form in the cartilage.

In the knee, such cartilage damage can occur between the femur (thigh bone) and the tibia (shin bone). In the ankle, osteochondral lesions usually occur on the talus, which is the bone that connects the leg to the foot.

After the initial pain and discomfort of a strain or sprain subsides, individuals usually resume or even increase their activity level. If an osteochondral lesion has occurred, however, everyday activities that put pressure on the joint, may lead to pain and swelling, although the joint usually is fine when at rest. A patient with an osteochondral lesion will often feel a dull ache in the joint and may also experience a mild locking or clicking of their knee or ankle joint. The affected joint may also seem to be loose.

It can be challenging to diagnose an osteochondral lesion at the time of injury. Many scans may miss the damage caused by the lesion, which is also masked by the sprain or trauma that caused the injury.

A physician will examine the joint for instability and range of motion. An X-ray may be ordered, but a cartilage tear is difficult to see on an X-ray, so a magnetic resonance imaging (MRI) or computed tomography (CT) scan may be required. In some cases, both an MRI and CT are needed to diagnose an osteochondral lesion.

SUPPORTING EVIDENCE

GENERAL ORTHOPEDICS

PUBLICATIONS

 
Connolly J, et al. Autologous marrow injection as a substitute for operative grafting of tibial nonunionsClinical Orthopaedics and Related Research. 263: 259-270. 1991.
 
Ganji V, et al. Treatment of osteonecrosis of the femoral head with implantation of autologous bone-marrow cells: a pilot study. Journal of Bone and Joint Surgery. 1153-1160. 2004.
 
Hendrich C, et al. Safety of autologous bone marrow concentrate transplantation: initial experiences in 101 patientsOrthop Rev. 1:e32. 2009.
 
Hernigou P, et al. Cancer risk is not increased in patients treated for orthopaedic diseases with autologous bone marrow cell concentrateJ Bone Joint Surg Am. 95 (24): 2215-2221. 2013.
 
Hernigou P, Poignard A, Beaujean F, and Rouard H. Percutaneous autologous bone marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 87:1430-1437. 2005.

SPORTS MEDICINE

PUBLICATIONS

Jang SJ, et al. Platelet-rich plasma (PRP) injections as an effective treatment for early osteoarthritisEur J Orthop Surg Traumatol. 2013;23: 573-580. doi: 10.1007/s00590-012-1037-5

 
Franklin, S. et al. The use of platelet-rich plasma for percutaneous treatment of tendinopathiesOperative Techniques in Orthopaedics. 2013;23(2):63-68.
 
Finnoff JT, et al. Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injectionAmerican Academy of Physical Medicine and Rehabilitation. 2011;3(10):900-11. doi: 10.1016/j.pmrj.2011.05.015
 
Lee J, et al. Platelet-rich plasma injections with needle tenotomy for gluteus medius tendinopathyThe Orthopaedic Journal of Sports Medicine. 2016;4(11). DOI: 10.1177/2325967116671692
 
Podesta L, et al. Treatment of partial ulnar collateral ligament tears in the elbow with platelet-rich plasmaThe American Journal of Sports Medicine. 2013;41(7):1689-94. doi: 10.1177/0363546513487979
 
Scollon-Grieve KL, et al. Platelet-rich plasma injection for partial tendon tear in a high school athlete: a case presentationAmerican Academy of Physical Medicine and Rehabilitation. 2011;3(4):391-5. doi: 10.1016/j.pmrj.2010.11.008
 
Sampson S, et al. Platelet-rich plasma therapy as a first line treatment for severe Achilles tendon tear: a case reportInternational Journal of Therapy and Rehabilitation. 2011;18(2):101-106.
 
Wilson JJ, et al. Platelet-rich plasma for the treatment of chronic plantar fasciopathy in adults: a case seriesFoot & Ankle Specialist. 2014;7:61-7. doi: 10.1177/1938640013509671 

SURGICAL ORTHOPEDICS

PUBLICATIONS

 

Everts PA, et al. Exogenous application of platelet-leukocyte gel during open subacromial decompression contributes to improved patient outcomeEur Surg Res. 2004;40:203–210. DOI: 10.1159/000110862
 
Hannon CP, et al. Arthroscopic bone marrow stimulation and concentrated bone marrow aspirate for osteochondral lesions of the talus: a case-control study of functional and magnetic resonance observation of cartilage repair tissue outcomesArthroscopy. 2016;32(2): 339-347.
 
Krych A, et al. Bone marrow concentrate improves early cartilage phase maturation of a scaffold plug in the knee: a comparative magnetic resonance imaging analysis to platelet-rich plasma and controlAm J Sports Med. 2016;44: 91. DOI: 10.1177/0363546515609597
 
Lee GW, et al. Is platelet-rich plasma able to enhance the results of arthroscopic microfracture in early osteoarthritis and cartilage lesion over 40 years of age? Eur J Orthop Surg Traumatol. 2013;23(5):581-7. doi:10.1007/s00590-012-1038-4
 
Rodriguez-Collazo ER, et. al. Combined use of the Ilizarov method, concentrated bone marrow aspirate (cBMA), and platelet-rich plasma (PRP) to expedite healing of bimalleolar fracturesStrategies in Trauma and Limb Reconstruction. 2015;10(3):161-166. doi: 10.1007/s11751-015-0239-x
 
Rodriguez-Collazo ER, et al. A retrospective look at integrating a novel regenerative medicine approach in plastic limb reconstructionPlast Reconstr Surg Glob Open. 2017;5(1):e1214. doi: 10.1097/GOX.0000000000001214
 
Rodriguez-Collazo ER.  Combined use of the illizarov method, concentrated bone marrow aspirateOrthopedics & Rheumatology. 2015;1(3): 555561.
 
Rodriguez-Collazo ER, et al. Bone marrow concentrate enriched in platelet growth factors combined with de-mineralized bone matrix for complex revision and complex lower limb arthrodesisOrthop Rheumatol Open Access J. 2015;1(2): 555558.
 
Rodriguez-Collazo ER, et al. Combined use of the Ilizarov method, concentrated bone marrow aspirate (cBMA), and platelet-rich plasma (PRP) to expedite healing of bimalleolar fracturesStrat Traum Limb Recon. 2015;10:161-166. DOI 10.1007/s11751-015-0239-x
 
Skoff HD. Revision rotator cuff reconstruction for large tears with retraction: a novel technique using autogenous tendon and autologous marrowAm J Orthop. 2015;44(7):326-331.
 
Smyth N, et al. The effect of platelet-rich plasma on autologous osteochondral transplantation: an in vivo rabbit modelJ Bone Joint Surg Am. 2013 Dec 18;95(24):2185-93. doi: 10.2106/JBJS.L.01497
 
Vavken P, et al. The effect of platelet concentrates on graft maturation and graft-bone interface healing in ACL reconstruction in human patients: A systematic review of controlled trialsArthroscopy. 2011;27(11):1573-83. doi: 10.1016/j.arthro.2011.06.003
 
Vogrin M, et al. The effect of platelet-derived growth factors on knee stability after anterior cruciate ligament reconstruction: a prospective randomized clinical studyWien Klin Wochenschr. 2010;122 (2): 91–95. doi: 10.1007/s00508-010-1340-2
 
Zavadil D, et al. Autologous platelet gel and platelet poor plasma reduce pain with total shoulder arthroplastyJECT. 2007;39:177–182.
 
Zhong W, et al. In vivo comparison of the bone regeneration capability of human bone marrow concentrates vs. Platelet-rich plasmaPLoS ONE. 2012;7(7): e40833. doi:10.1371/journal.pone.0040833

VIDEOS

Vivostat Logo

THE VIVOSTAT® SYSTEM

The uniqueness of the Vivostat® system is a novel patented biotechnological process that enables reliable and reproducible preparation of autologous Fibrin Sealant or Platelet Rich Fibrin (PRF®) without using cryoprecipitation and without the need for a separate thrombin component.

THE FULLY AUTOMATED VIVOSTAT® SYSTEM CONSISTS OF THREE COMPONENTS:

  • The Processor Unit is a non-sterile, reusable, fully automated device that controls the biochemical process.
  • The Processor Unit is used to process the patient’s blood and prepare the Vivostat® Fibrin Sealant or Vivostat PRF® solution.
Vivostat Processor Product
  • The Processor Unit is operated by a single button and a display keeps the nurse informed of the remaining process time and status at all times. No specific installation is required and the large wheelbase makes moving it easy.
  • The Processor Unit can be located in any room or corridor in the operating department. It is most often placed centrally between the operating theatres. This way one Processor Unit can supply a number of operating theatres.
  • In approx.  25 min a concentrated fibrin sealant or PRF® solution is prepared from the patient’s whole blood.
  • The Applicator Unit is a non-sterile, reusable, fully automated device that controls the delivery of the Vivostat® Fibrin Sealant or Vivostat PRF®.
Vivostat Processor Product
  • The large display and integrated microprocessor automatically primes the Spraypen® and informs the surgeon of the remaining volume of fibrin sealant/PRF® throughout the entire process.
  • Different spray modes can be selected depending on the actual procedure or area to be covered. Like the Processor Unit it has a large wheelbase and can easily be moved if required.
  • The disposable set comprises of two parts: A Preparation Kit used to prepare the fibrin sealant or PRF® solution before surgery, and an Application Kit used to activate and apply the fibrin sealant/PRF® solution.

 

  • Preparation Kit
    The Preparation Kit contains the specially designed Preparation Unit – a sterile disposable device in which the patient’s blood is collected, the biochemical process carried out, and the fibrin sealant or PRF® solution harvested.

 

  • The Application Kit
    The Application Kit contains the Spraypen®1 and all other items required to prepare the system for the delivery of the fibrin sealant or PRF® solution. The Spraypen® is a sterile, disposable, hand held device which delivers the fibrin sealant or PRF® solution to the tissue. The revolutionary and patented design offers the surgeon unparalleled freedom in controlling the application unlike any other product on the market today.

 

1Besides the Spraypen®, the Vivostat® system offers different types of applicators, e.g. the Endoscopic Applicator. For a full list of application devices click here

1-2-3 Spray

Three easy steps to prepare Vivostat® Fibrin Sealant or Vivostat PRF®

1. Draw blood from the Patient

Fibrin Prep With Blood Inside

At the time of surgery or up to 24 hours before1, citrate (supplied with the kit) is added to the Preparation Unit. 120 ml of the patient’s own blood is then drawn into the same unit.

2. Process the patient’s blood

Vivostat Processor 800

The Preparation Unit is placed in the Processor Unit. At the touch of a button the process starts; after approx. 25 minutes, an autologous fibrin or PRF® solution is ready for use. No thrombin or bovine components are added to the blood at any time.

3. Load the Applicator Unit and spray

Vivostat Display Applicator

The Fibrin or PRF® solution is easily loaded into the Applicator Unit and applied to the surgical site using one of the unique application devices (e.g. the Spraypen). 1This depends on the type of kit being used. Always consult the “Instructions for Use” supplied with the kit to determine the correct preparation.

The following video illustrates how to prepare and apply autologous fibrin sealant.

Presentation DVD from Vivostat A/S on Vimeo.