Osseointegration
Osseointegration
What is Osseointegration?
Osseointegration is a surgical procedure for amputees that allows an external surgical implant to be directly attached into the bone. The surgery is a two-stage process over a 6-8 week period with a post-surgery rehabilitation program. Osseointegration is the scientific term for bone ingrowth into a metal implant which is permanently, surgically implanted and integrated into the residual bone of an amputee. It eliminates the need for a traditional socket-mounted prosthesis and increases comfort, mobility and quality of life.
Stage 1: Insert Femoral Implant
The femoral implant is inserted into the femur during the first surgery.
Stage 2: Insert External Prosthesis
After the patient recovers for 6-8 weeks and the implant undergoes osseointegration, the external prosthesis is inserted into the stub.
What is an endo-exo prosthesis?
An endo-exo prosthesis is a modular prosthesis designed to osseointegrate with the intermedullary canal of the femur to act as a transcutaneous, distal intramedullary device, with a distal external coupling system which serves to connect with the above knee amputation (AKA) prosthetic.
It consists of:
1) An endo-exo femoral prosthesis that provides a secure and durable fixation within the femur.
2) A distal hard-point attachment that exits through the skin that allows an attachment to a prosthetic limb, providing direct transmission of load to the external component.
Indications for an
endo-exo implant ?
You may be considering an osseointegration implant if you are an amputee who experienced:
- Traumatic injury.
- Infection in a joint replacement that did not respond to antibiotics or alternative treatments.
- Cancer where tumours are formed around the bone or muscle.
- Neuroma when a nerve issue is thickened.
- Frostbite.
- Burns.
Surgical Technique
STAGE 1
Femoral Preparation
Preparation of the soft tissue and
uncovering of the distal femur.
Canal Reaming
Using a modular Olive reamer. Ream the medullar cavity to the predetermined diameter
Implant Insertion
Insert the implant into the bone using the Stem Impactor.
Surgical Technique
STAGE 1
Femoral Preparation
Preparation of the soft tissue and
uncovering of the distal femur.
Canal Reaming
Using a modular Olive reamer. Ream the medullar cavity to the predetermined diameter
Implant Insertion
Insert the implant into the bone using the Stem Impactor.
Surgical Technique
STAGE 2
Preparation for Component Insertion
Locate the end of the implant and using a scalpel cut a Ø20mm hole, to fit the post center of the stem.
(Soft Tissue interface: stoma/skin)
OLD Fashion: WET STOMA
CURRENT best practice: DRY STOMA
Insertion and assembly of Dual Taper Post
Insert the Dual Taper Post using the Insertion Tool and fasten with the Dual Taper Post screw to specified torque
Assembling the Silicon Cap and the Prepatory Sleeve and Cap
Gently push the Silicon Cap over the assembly to hold the gauze. Then assemble the Prepatory Sleeve and the Prepatory Cap to protect the Taper.
STAGE 3
Prosthesis connection after rehabilitation and full implant integration.
Surgical Technique
STAGE 2
Preparation for Component Insertion
Locate the end of the implant and using a scalpel cut a Ø20mm hole, to fit the post center of the stem.
(Soft Tissue interface: stoma/skin)
OLD Fashion: WET STOMA
CURRENT best practice: DRY STOMA
Insertion and assembly of Dual Taper Post
Insert the Dual Taper Post using the Insertion Tool and fasten with the Dual Taper Post screw to specified torque
Assembling the Silicon Cap and the Prepatory Sleeve and Cap
Gently push the Silicon Cap over the assembly to hold the gauze. Then assemble the Prepatory Sleeve and the Prepatory Cap to protect the Taper.
STAGE 3
Prosthesis connection after rehabilitation and full implant integration.
VIEW PRODUCT INFORMATION1. The Longitude™ stem is designed to work with various 3rd party leg adaptors in additional to our own. SignatureOrtho leg adaptor includes safety limits and quick release levers as standard
2. Silicon cover which secures gauze in place.
3. A split fin design on the proximal end of the stem, accommodates the femur bend better as it provides some flex, and reduces thigh pain.
4. Titanium Plasma Spray (TPS) + HA + Silver Coating to enhance bone growth and reduce infection.
5. Longitude™ is custom made, each stem is perfectly engineered to the patients needs.
7. Dual taper posts, which are available in different lengths to achieve desired length, independent to bone stock.
Product currently in development. Not approved for sale in the US.
6. Dual shear pins. These pins act as a final safety measure, designed to break in the event of dangerous amounts of torque.
Signature Orthopaedics’ Longitude™ and Latitude Implant System is a solution that offers improved functionality and lifestyle of an amputee over conventional prosthetic devices.
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Longitude™ Stem Features
What are the benefits?
Signature Orthopaedics’ state-of-the-art osseointegration implants aim to help amputees achieve a new level of mobility,
control and comfort over conventional prosthetic devices.
Increased joint range of motion
Long-term muscular development is improved with increased range of motion.
Regenerate proprioception
Perception of the position and movement of the body is restored as awareness of ground and general surfaces improves.
Stability
Direct load transmission from bone to prosthesis restoring full control and stability of the limb.
Longer periods of endurance and improved sureness of walking compared with shaft prosthesis.
Comfort
All socket problems such as discomfort, bruising, rubbing, and sweating are eliminated. Lack of dependence on already existing scars.
Improved gait symmetry
A more natural gait and mobility are achieved with increased muscle use.
Easy to operate
Simple second-stage procedure that involves a single screw attachment that can be done in seconds.
Accommodating weight changes
Changing body weight and the resulting modified stump form.
Fast rehabilitation
Post-surgery rehabilitation program reduces overall recovery period by 4 to 6 weeks.
Pain improvement
An overall pain improvement is achieved with reduced energy expenditure.
Cost-effective
Save significantly on cost as regular socket re-fittings are no longer needed.
What is the clinical summary of endo-exo prosthesis?
Clinical outcomes from a case series1
| Current Study | Current Study | Hagbergand Branemark 2001 | Hagberg et al 2014 | Hagberg et al 2008 | ||
| OI (Uniteral Only) | OI | Amputee | Match-general population | Amputee | Amputee | |
| Sample size | 8 | 9 | 97 | 1067 | 39 | 17 |
| Physical Functioning | 46.9, 34.2, 59.6,43 (30-85) | 42.8, 29, 56.6, 40 | 46.45, 41.4, 51.5 | 86.35, 85.2, 87.5 | 35.7, 29.0, 42.4, 30 | 31, 21, 41 |
| Role Functioning-Physical | 56.3, 25.9, 86.6, 63 (0-100) | 50.0, 20.6, 79.4, 50 | 49.5, 40.6, 58.4 | 81.5, 79.5, 83.5 | 38, 16, 60 | |
| Bodily Pain | 61.9, 50.8, 72.9, 64 (45-90) | 55.0, 38.4, 71.6, 58 | 50, 45.2, 54.8 | 72.1, 70.5, 73.7 | 53, 36, 71 | |
| General Health | 83.1, 71.5, 94.7, 85 (60-100) | 78.3, 64.4, 92.2, 80 | 65.4, 60.8, 70.8 | 72.7, 71.2, 74.1 | 75, 64, 86 | |
| Vitality | 71.3, 59, 83.5, 75 (35-85) | 63.3, 44.4, 82.2, 75 | 56.0, 51.2, 60.8 | 67.0, 65.0, 68.9 | 61, 50, 72 | |
| Social Functioning | 78.1, 63.7, 92.6, 88 (50-100) | 69.4, 48.2, 90.7, 88 | 76.7, 72.0, 81.4 | 87.0, 85.7, 88.3 | 80, 74, 96 | |
| Role Functioning-Emotional | 79.2, 51.7, 106.6,100 (0-100) | 70.4, 40.7, 100.1, 100 | 70.5, 62.4, 78.6 | 85.1, 83.3, 86.90 | 78, 61, 95 | |
| Mental Health | 81.5, 66.5, 96.5, 90 (32-100) | 76.9, 60.9, 92.9, 88 | 72.9, 68.6, 77.2 | 80.1, 78.9, 81.3 | 76, 68, 84 | |
| PCS | 62.0, 49.3, 74.7, 66 (36-86) | 56.5, 41, 72.1, 63 | 32.1, 29.2, 35.0, 30.5 | 31, 27, 35 | ||
| MCS | 77.5, 64.3, 90.7, 88 (53-96 | 70.0, 51.3, 88.7, 88 | 55, 51, 59 | |||
Discussion:
This prospective case series sought to evaluate a unique OI device and its impact on recipient patients’ quality of life and function. Study group patients were evaluated for differences in quality of life based on the SF36 and Q-TFA, prosthetic use, residual limb pain, back pain, and overall satisfaction in transfemoral amputees relative to their peers. The results were consistent with previously pub- lished literature comparing patients treated with OI. (cite) Although not all findings were statistically significant, all metrics measured were found to be trending higher than those reported by peers not treated with OI. The improvements in scores are likely due to clear expectations, risks and benefits of the device, proper skin care, patient motivation, and previously failed use of a traditional socket suspended prosthesis.
1 Novel Custom Osseointegration Implant for Transfemoral Amputation, a Case Series Moyer, Benjamin. Hillock MD, Ronald. Allison MD, Daniel C.
What Makes Us Different?
1. SignatureOrtho™ Endo-Exo prosthesis uses a clinically proven cylindrical press fit porous coated design. A traditional approach to fix internal prostheses where on-growth of bone is important. The principles of this design are derived from femoral hip prosthesis.
2. SignatureOrtho™ Endo-Exo prostheses are coated with an Acusure Ag® coating. This innovative surface coating, which harnesses the anti-microbial properties of silver to significantly reduce infection rates following implant surgery. Surfaces treated with Acusure Ag® technology have been shown to inhibit biofilm formation in vitro, and clinical data from the field of limb salvage using silver-based antimicrobial surface treatments such as the Agluna® technology (at comparable silver doses) have shown a demonstrable reduction in near-term infection rates in patients at high risk of infection.
3. Unique proximal tip geometry allowing for a better fit, and reduced thigh pain.
AUSTRALIA
7 Sirius Rd Lane Cove West NSW 2066, Australia
Tel +61 2 9428 5181
Fax: +61 2 8456 6065
www.signatureortho.com.au
USA
3150 Stage Post Drive, Suite 104, Bartlett TN 38133
Tel: +1 844 762 9221
Fax: +1 855 630 9555
info@signatureortho.us
IRELAND
Unit A, IDA Business and Technology Park, Garrycastle, Athlone, N37 DY26, Ireland
Tel: +353 (0) 906400539
info@signatureortho.eu
FRANCE
Espace Entreprises – L’Arobase, 2 Rue Georges Charpak F-81100 CASTRES
Tel: +33(0)5 6373 5183
Fax: +33(0)5 6373 5184
info@signatureortho.eu
Product under development. Not approved for sale in the US.