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CONCEPT

People with above or below knee amputations seek to return to an independent and mobile lifestyle.

Conventional rehabilitation uses a socket prosthesis, which is fixed to the soft tissue of the remaining residual limb using suction or vacuum. The artificial knee joint and/or lower leg prosthesis is then attached to the socket. This enables the patient to walk without aids, but there are several challenges in the use of a suction prosthesis.

One important factor is the length of the remaining limb, as it determines the lever arm and the force, which has to be applied for conducting, guiding, and controlling the prosthesis. If the socket does not fit properly, it can create skin irritations of the soft tissue which may lead to sores, ulcers, and chronic inflammation with abscesses and pain.

Moreover, the remaining stump length correlates with the energy expenditure during walking. On average, an amputee uses 70% more energy than an able-bodied person. These difficulties can result in a poor gait with negative effects on the remaining musculoskeletal system and often leads amputees to utilize walking aids or even a wheelchair.

For many amputees, it is difficult to find a way back into an active lifestyle or to the working force. Often, they cannot perform activities or sports, and have to rely on the help of others during everyday life.

REVIVO SYSTEM OFFERS

  • Optimum fit of the prosthesis– even in case of variation of weight and stump volume
  • Direct load transmission via prosthesis to bone for a maximum control of the exo-prosthesis
  • Almost physiological gait
  • No skin irritation due to friction, chaffing, and squeezing
  • No increased sweating and heat rashes
  • No inflammation, bruises, hematoma, pressure mark or deep skin injuries
  • No pain while sitting
  • Comfortable handling of the prosthesis
Before

Unnatural position of the femur in a socket prosthesis

After

Femur position is more anatomically correct

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BENEFITS

MORE QUALITY OF LIFE WITH REVIVO

No socket – Perfect fit – No pain!

The major advantage of the ReVivo System is the absence of a socket. This ensures the prosthesis always fits comfortably, always attaches correctly, and is always held firmly in place regardless of activity level, fluid fluctuations, perspiration levels, or weight loss/gain. The absence of a socket does also mean that the main reason for skin irritation and inflammation of the soft tissue is eliminated. Finally, it also allows for a natural streamlined look in clothing.

Full freedom of movement

The REVIVO System allows for full freedom of movement from walking to cycling and other recreational activities. Movement is no longer restricted by the protruding edges of a socket, allowing for greater ease and comfort when sitting, standing, walking, or engaging in vigorous sports activities such as speed cycling or rowing.

Regaining Osseoperception

Following osseointegration surgery, the patient regains their sense of proprioception, which is the unconscious perception of the position of the body, movement, and spatial orientation in relation to the external environment. This means that patients regain the ability to actually feel the ground beneath them as they walk and differentiate between different surfaces such as grass, carpet, tile, uneven ground, and gravel. This allows for safer and more confident movement even in unfamiliar areas or dim light.

Improved femur position and gait

Following osseointegration, femur position Is improved and muscle use and control increase. This results frequently in a more natural walking gait. Improvements in range of movement and natural pivoting in the hip and knees also contributes to an improved gait.

Muscle and bone strength

Walking with ReVivo System allows for natural loading of the hip joint and the femur, which encourages bone growth. Muscle strength is developed freely and walking requires significantly less physical exertion.

Easy and secure attachment

Due to the solid fixture to the bone, donning and doffing the prosthesis is very easy. The ReVivo System can be used with all certified types of prosthetic componentry and offers a real alternative solution to the often time consuming handling of traditional sockets and liners.

Cost savings

With the ReVivo system, the regular need for new stump cups and all associated accessories is eliminated, which in the long run causes a considerable cost.

IMPLANT TECHNOLOGY

The REVIVO system is a modular system that can be divided into an internal module being implanted and an external (exo) module.

The REVIVO system is made up of several different components that can be divided into an internal (endo) module and an external (exo) module.

The endo module, a femoral stem, is directly implanted into the bone. There are a range of implants to meet the needs of varying patients. The stem surface is built by a 3D macro structure, which allows the bone to grow inside the surface of the prosthesis making the bone-implant structure one solid unit resulting in long-term bone integration (ingrowth). This is known as osseointegration. This technology has been successful in clinical use around the world for more than 30 years in joint replacement surgery.

The dual cone adapter connects the internal implant to the external prosthesis. This extension has a highly polished smooth surface to minimize soft tissue friction. It is also coated with a titanium niobium, which has antibacterial properties. This passes through a small opening in the skin known as the stoma. Externally, the dual cone adapter is fixed to a torque controlled safety device comprised of a taper sleeve connector and an anti-rotational locking bushing that are held together by a locking fixture. This further connects to an adapter that then connects to the lower prosthetic limb. There are different adapters available, with different features, yet all are compatible with the various prosthetic componentry in today’s market.

PRODUCT DESIGN

  • ReVivo® femoral stem

    » DETAILS

  • ReVivo® dual cone adapter

    » DETAILS

  • ReVivo® safety screw for dual cone adapter

    » DETAILS

  • ReVivo® silicone cover

    » DETAILS

  • ReVivo® taper sleeve

    » DETAILS

  • ReVivo® locking screws x 2
    ReVivo® locking screw propeller shaped
    ReVivo® trial locking screw

    » DETAILS

  • ReVivo® EndoExo® Knee adapter

    » DETAILS

  • ReVivo® extension adapter (optionaly)

    » DETAILS

  • ReVivo® Training prosthesis

    » DETAILS

  • ReVivo® taper protection for femoral stem

    » DETAILS

Exploded view prosthesis

ReVivo® femoral stem

The ReVivo® femoral stem has a three-dimensional macro surface structure that ensures a safe and stable ingrowth of the implant in the femur - the so-called osseointegration. A maximum stable anchoring of the implant in the bone allows the direct transmission of force to the muscles and the prosthesis and is the prerequisite for a good gait pattern.

The ReVivo® femoral stem is made of a cobalt-chromium molybdenum (CoCrMo) cast alloy. For protection against allergies, each stem is equipped with a titanium niobium coating as standard, as well as a titanium niobium oxinitrite (TiNb (ON)) coating on the polished surfaces.

Advantages:

  • Secure and stable implant anchoring by 3D macro surface
  • Direct force transmission on muscle and prosthesis
  • Also suitable for allergy patients

ReVivo® dual cone adapter

The ReVivo® dual cone adapter is the link between endo and exo components. It connects the femoral stem to the ReVivo® EndoExo® knee adapter. The dual cone adapter is made of a cobalt-chromium-molybdenum (CoCrMo) forging alloy and is coated with titanium niobium (TiNb) as standard and titanium niobium oxynitrite (TiNb (ON) for polished surfaces).

ReVivo® safety screw for dual cone adapter

The ReVivo® safety screw is used to secure the ReVivo® dual cone adapter in addition to conical clamping against unwanted decoupling. The locking screw is made of a titanium aluminum vanadium (TiAlV) forging alloy.

ReVivo® silicone cover

The silicone cover is a hygienic protection measure. It encloses the outlet area of the prosthesis (ReVivo® dual cone adapter) and fits into the lower leg stump. The silicone cap holds the compressive force around the outer prosthesis in position to receive body secretion. To allow additional air circulation, the material is perforated. The silicone cap is made from the silicone addisil.

ReVivo® taper sleeve

The taper sleeve and the rotating disc are used for the connection and guidance of the knee connection adapter and thus the exoprosthetic leg prosthesis. The connector sleeve for connection adapters has an inner cone open on both sides. By means of this inner cone, the conical sleeve can be coupled with the distal outer cone of the double cone adapter. The taper sleeve is made of a cobalt-chromium (CoCr) forging alloy.

ReVivo® bushing

The ReVivo® bushing is attached to the distal end face of the ReVivo® taper sleeve. It is produced from a cobalt-chromium-molybdenum (CoCrMo) forging alloy. The axial bore of the ReVivo®  bushing is provided with a step, whereby a support surface is formed, on which the sample closure screw or plug screw propeller shaped later rests. The pins serve to secure the rotation setting.

ReVivo® locking screws x 2

ReVivo® locking screw propeller shaped

The ReVivo® locking screw propeller shaped permanently secures the connection of the rotating disk, taper sleeve and dual cone adapter. In addition to the screw locking system, the specially designed screw head ensures a stable toothing in the rotating disk. The plug screw is made of a cobalt-chromium-molybdenum (CoCrMo) forging alloy.

ReVivo® trial locking screw

The ReVivo® trial locking screw secures the connection of the rotary disk, the taper sleeve and the dual cone adapter.

It is used by the orthopedist for the temporary screw connection after the operation until the final adjustment of the exoprosthesis. Then replace the trial locking screw for permanent securing with the propeller shaped screw. The sample closure screw is made from a cobalt-chromium molybdenum (CoCrMo) forging alloy

ReVivo® EndoExo® Knee adapter

The ReVivo® EndoExo® knee adapter is the connecting piece between the endoprosthesis and the exoprosthetic leg supply. Its special shaping serves for the natural leg alignment and thus provides an approximately physiological gait pattern. The adapter is made of cast stainless steel.

ReVivo® extension adapter (optionaly)

The ReVivo® extension adapter is used to adjust the length of the leg and is available in different lengths in order to allow a maximum patient-specific adaptation of the exo-prosthesis. Extension adapters and threaded pins are made of stainless steel.

ReVivo® Training prosthesis

In order to support osseointegration as a whole, the load on the implanted prosthesis should be successively increased. This is done with the aid of the training prosthesis. This is simply linked to the exocomponents and can be used for the duration of physiotherapy.

3D tripod structure

The three-dimensional tripod structure on the ReVivo® Femurstiel is a secure connection between the bone and the implant by osseointegration in its dimensioning (structure and bridge thickness). Structural height and implant core are produced as a homogeneous cast in one piece.

ReVivo® taper protection for femoral stem

The ReVivo® taper protection is screwed to the femoral stem after implantation and thus reliably closes the inner cone during the healing phase. The closure screw consists of a cobalt-chromium molybdenum (CoCrMo) forging alloy and is coated with titanium niobium (TiNb) as standard and titanium niobium oxinitrite (TiNb (ON)) on the polished end face.

ReVivo® extension module

The stainless steel extension module has been designed to provide short stumps and is used to adjust the leg length. The extension module is firmly coupled to the EndoExo® knee adapter via a screw connection. For a patient-specific adaptation, the extension module is available in different lengths.

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INDICATION

The ReVivo System was developed for patients with above and below knee amputation.

Referrals of prospective patients are commonly provided through rehabilitation physicians, general practitioners or prosthetists, or arise from direct enquiries. As an osseointegrative system is not in any case applicable, the first step leads all prospective patients to a detailed anamnesis.

CRITERION FOR EXCLUSION FOR THE REVIVO SYSTEM WOULD BE

  • Peripheral vascular disease
  • Receiving chemotherapy
  • Receiving irradiation
  • Mentally unstable
  • Unrealistic expectations
  • Smoking *
  • Growing skeleton *
  • Non-compliance

* Candidates initially excluded may be reconsidered if circumstances change.

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