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Osseointegration is a remarkable procedure that involves creating a structural connection between human bone and the surface of a synthetic implant, often made of titanium. This surgical innovation allows above- and below-knee amputees to receive a leg replacement using the OGAP-OPL implant, which is designed to be as close to the human anatomy as possible.
Osseointegration surgery entails the insertion of a metal implant into the remaining bone of an amputee. This implant serves as a direct anchor for an external prosthesis, eliminating the necessity for the amputee to rely on a conventional socket-mounted prosthesis.
This innovative technology establishes a robust and close biomechanical link, allowing direct loading onto the amputee’s skeletal system. It has been demonstrated to significantly enhance the quality of life for individuals with amputations.
Under the expertise of Prof Munjed Al Muderis and The Osseointegration Group, this surgery offers amputees improved mobility, comfort, and an enhanced quality of life. The implant is inserted into the amputee’s stump bone and, when integrated with the bone, allows for a simple, quick, and safe connection between the stump and the lower prosthesis.
Like any medical procedure, Osseointegration has specific indications and contraindications. Here are the typical indications and contraindications for the procedure:
Amputation: Limb osseointegration is indicated for individuals who have undergone limb amputation, as it offers an alternative attachment method for prosthetic limbs.
Unsatisfactory Socket Fit: For amputees who have difficulty with traditional socket-based prostheses, osseointegration can provide better comfort and function by eliminating socket-related issues.
Desire for Improved Function: Individuals who seek improved prosthetic limb function, mobility, and comfort may be good candidates for osseointegration.
Active Lifestyle: Osseointegration is suitable for those with active lifestyles who require enhanced prosthesis stability and the ability to engage in physical activities or sports.
Healthy Bone Condition: Adequate bone quality and quantity at the implantation site are essential for the success of osseointegration. Patients with healthy bone structure are more suitable candidates.
Inadequate Bone Quality or Quantity: Patients with insufficient bone volume or poor bone quality at the implantation site may not be suitable candidates for osseointegration. Sufficient bone support is crucial for successful integration.
Active Infection: Active or chronic infections at the surgical site can hinder the osseointegration process and are generally considered contraindications. Infections must be treated and resolved before surgery can proceed.
Radiation Therapy: Patients who have undergone radiation therapy in the area of implantation may have impaired bone healing and may not be suitable candidates for osseointegration.
Uncontrolled Medical Conditions: Individuals with uncontrolled medical conditions, such as unmanaged diabetes, bleeding disorders, or severe cardiovascular problems, may be at higher risk of complications and may not be good candidates.
Certain Medications: Some medications, like bisphosphonates used for bone disorders, can negatively affect bone healing and may be contraindications. Medication history should be thoroughly assessed.
Psychological Factors: Psychological factors, such as unrealistic expectations or significant anxiety about the procedure, can be considered contraindications. A comprehensive psychological evaluation may be necessary.
Patient Preference: Patient preferences and willingness to undergo the procedure are important factors. If a patient is not comfortable with osseointegration or prefers alternative treatments, their choices should be respected.
The decision to undergo limb osseointegration should be based on a thorough evaluation. Patients should discuss their specific condition, medical history, and individual preferences with the medical team to determine whether osseointegration is a suitable option for their needs.
Initially used in bone and joint replacement surgeries, Osseointegration has not only improved these procedures and their outcomes but has also revolutionised the quality of life for amputees.
Since 1995, osseointegration has been used clinically. This involves a titanium implant integrated with the skeleton, connected via an opening in the stump (stoma) to an external prosthetic limb. This eliminates the need for the traditional suction prosthesis, and the perfect fit is achieved through a torque-controlled connector.
The direct connection to the ground enhances stability and control and reduces energy expenditure.
The Osseointegration Group of Australia Osseointegration Prosthetic Limb (OGAP-OPL) implant is designed to mimic the natural anatomy of the human body. This innovative implant effectively transfers the load to the bone’s stump during walking. In contrast, traditional socket prostheses do not distribute the load in a natural manner, which can contribute to bone degeneration, atrophy, and even the development of osteoporosis and arthritis.
The OGAP-OPL is suitable for individuals with both above and below knee amputations and is implanted directly into the tibia or femur as needed.
No Need for a Socket
Enhanced Mobility
Easy Attachment and Osseoperception (Improved Sensation)
Limb osseointegration is a surgical procedure that can significantly improve the attachment of prosthetic limbs by connecting them directly to the bone. While it offers numerous benefits, there are also potential risks and complications associated with the procedure. These risks can vary depending on the patient’s specific situation and health status. You can find detailed information about the procedure, its benefits and risks by visiting our Osseointegration website. Here are some of the common risks of osseointegration:
Infection: Infection is a potential risk with any surgical procedure. In the case of limb osseointegration, there is a risk of infection at the site where the implant penetrates the skin and connects with the bone. Proper wound care, antibiotic prophylaxis, and strict hygiene protocols are implemented to minimise this risk.
Implant Failure: Implant failure can occur if the prosthetic attachment does not integrate properly with the bone. Factors such as inadequate bone quality, poor implant positioning, or excessive load on the implant can contribute to failure.
Soft Tissue Complications: The interface between the implant and the soft tissues can sometimes lead to complications, including discomfort, pain, or skin irritation.
Implant Loosening: Over time, the implant may loosen, causing pain and reduced stability. This can necessitate revision surgery or additional procedures to address the issue.
Fracture Risk: Patients with an osseointegrated implant are at a slightly increased risk of bone fractures in the area surrounding the implant. Vigilant monitoring is essential to detect and address fractures promptly.
Nerve or Blood Vessel Damage: There is a risk of damaging nearby nerves or blood vessels during the surgical procedure, which can lead to sensory or motor deficits.
Discomfort and Pain: Some patients may experience ongoing discomfort or pain, especially during the initial healing period and rehabilitation process.
Functional Limitations: Limb osseointegration may have specific functional limitations, such as the inability to engage in certain high-impact activities. Patients must be informed about these limitations and make necessary adjustments.
Revision Surgery: In some cases, patients may require revision surgery or additional procedures to address complications or optimise implant function.
Psychological Impact: The psychological impact of osseointegration, including the adjustment to the new prosthetic limb and the surgical process, can affect some individuals. Psychological support may be necessary.
The surgical approach for limb osseointegration is highly specialised and requires the skills of experienced orthopaedic surgeons and prosthetic specialists. The specific techniques and components used can vary depending on the patient’s individual needs and the type of prosthetic limb. The ultimate goal is to provide a stable and functional connection between the prosthesis and the residual limb, improving the patient’s mobility and quality of life.
The implantation of the OGAP-OPL can be carried out in a single surgery or divided into two stages, depending on the patient’s individual conditions and suitability.
Since each osseointegration patient’s circumstances are unique, the surgical process will vary slightly based on their specific needs and condition.
In the initial stage, the following steps are generally involved:
After the first stage, a period of six to eight weeks is allowed for osseointegration to occur. Subsequently, the second stage is initiated.
The second stage entails:
Partial weight-bearing and fitting of the lower prosthesis can commence within a few days after the second surgery, under the close supervision of the osseointegration team. At this point, rehabilitation and gait training can begin.
Pain control:
Following the surgery, patients will be taken to the recovery room for monitoring. Once their condition stabilises, they will be transferred to the orthopaedic ward.
The patient will be set up with a button to press to administer pain relief through a machine called a PCA machine (Patient-Controlled Analgesia). Additionally, ketamine will be given intravenously.
The post-op protocol may vary slightly for each patient, but typically, the drainage tube will be removed after 48 hours, or once the ketamine infusion has ceased. Once this has been removed, the patient can sit out of bed. The dressing will usually be reduced on the third day post-op to make movement easier.
A physiotherapist will be available to guide the patient through exercises and assist with rehabilitation and mobility.
Weight-bearing:
Partial weight-bearing and fitting of the lower prosthesis can commence within a few days after the second surgery, under the close supervision of the osseointegration team. At this point, rehabilitation and gait training can begin.
This stage begins with weight loading using a specialised stump loader fitted onto the tip of the implant. Commencing the loading phase involves performing five-minute loading sessions three times a day. During these sessions, individuals are tasked with exerting downward pressure on the loader until a specified weight is attained, as indicated by a set of scales. The weight and duration of loading will gradually increase over the course of a few days.
Gait Training:
Once a comfortable weight load equivalent to half of one’s body weight is achieved (this is accomplished by loading using a stump loader on a set of scales), the individual will be fitted with a lightweight leg, and gait training can commence.
During the period of gait training and weight loading, some muscle soreness should be expected, as the muscles are being used in new and different ways. This adjustment period is necessary for the muscles to adapt and gain strength.
For the initial 12 weeks, it is necessary to partially bear weight to ensure safe integration of the implant into the bone. This entails walking with at least one crutch or walking stick during this timeframe.
Although this phase is thrilling and the temptation to challenge oneself is strong, it is highly recommended to increase walking intensity slowly to prevent potential injuries arising from overly aggressive efforts.
Post-Surgery Care:
Attention should be given to the opening (stoma) through which the external adaptor emerges from the stump. Some discharge from the stoma is normal and varies among patients, with some experiencing none at all.
Adhering to regular daily hygiene practices greatly minimises the risk of infection. A daily shower, focusing on the stump and stoma, is all that is needed.
Safety Measures:
Excessive rotation, including abrupt pivoting and twisting motions, should generally be avoided. However, should significant strain occur, the safety shear pins in the external implant system are designed to break, safeguarding against bone fractures. This engineered system ensures the bone remains intact even as the device yields under strain. The primary focus is on safety, with the system designed to protect the bone during moments of intense strain or vigorous movement. Replacing the safety pins is a straightforward process for the prosthetist, and in the near future, there is the possibility they will be able to be replaced by the patient.
If patients are worried about their level of pain, experience significant bleeding, or notice fever or redness around the surgical site, they should contact the office immediately. If assistance is needed after hours, patients can contact the hospital where the surgery was performed, and they will contact Professor Al Muderis on their behalf.
Norwest Private Hospital: (02) 8882 8882
Macquarie University Hospital: (02) 9812 3000
X-ray facilities at all locations | Urgent appointments available if necessary.
Professor Munjed Al Muderis is an orthopaedic surgeon and a clinical professor at Macquarie University and The Australian School Of Advanced Medicine. He specialises in hip, knee, trauma and osseointegration surgery. He is a fellow of the Royal Australasian College of Surgeons and Chairman of the Osseointegration Group of Australia.