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TRANSCRIPT
5/12/2018
1
www.bestppt.com
Osseointegration:
Rates of Complication
& Re-operations
William Lu, PhD
Clinical Researcher,
The Osseointegration Group of Australia
Image Credit: Salehin Chowdhury @500px
DISCLOSURES
All patients gave consent prior to this presentation for the use of their
clinical data, images and videos.
The medical devices shown in this presentation is TGA and CE approved
for sale in the Australian, NZ, and European market. The medical devices
shown in this presentation is NOT FDA approved for sale in the US market.
I declare research interests in products mentioned. Research funding is
provided by the Australian Research Council (ARC) and Osseointegration
International Pty Ltd.
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5/12/2018
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The Socket Mounted Prosthesis
CURRENT STANDARD OF CARE
The Socket Mounted Prosthesis
CURRENT STANDARD OF CARE
5/12/2018
3
Paternò, Linda, et al. "Sockets for limb
prostheses: a review of existing technologies
and open challenges." IEEE Transactions on
Biomedical Engineering (2018).
CURRENT STANDARD OF CARE
COPY ONE COLUMN
• Skin Friction: Heat, rash, ulcers, blisters, perspiration, chafing,
infections and general discomfort
• Bad Mobility and Fit: Pistoning leads to energy loss, time spent donning and doffing,reduction of ipsilateral proximal joint movement, lack of
rotational control, diurnal variation of the residuum leading to poor fit and
lack of stability
• Diminished Proprioception: profound lack of sensory feedback reduces
confidence in walking
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Review on Socket Limb Prostheses
5/12/2018
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OSSEOINTEGRATED PROSTHESES
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Eliminating Persistent Socket Issues
ORIGIN OF OSSEOINTEGRATION
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OSSEOINTEGRATION PROSTHETIC LIMB (OPL)
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OPL: PRESS-FIT FIXATION
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REHAB COMPLETE (TYPICALLY 3-4 MONTHS)
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FREEDOM OF MOBILITY & COMFORT
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Benefits of
Osseointegration:
• Eliminate socket problems
• Lower energy consumption
• Increase proximal joint
range of motion
• Better stability
• Restore proprioception
• Reduction in several forms of amputation related pain
• Better comfort
Overall improved QOL
5/12/2018
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WORLDWIDE OI PATIENT COHORT and partners
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570 Osseointegration Cases Performed by OGA
750+Cases
Performed
Worldwide
THE RISK VS BENEFITS
These benefits are great, but:
What are the revision rates?
What are the rate of complications?
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5/12/2018
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COMPLICATIONS & RE-OPERATION RATEYou already know the good, now we show you the bad and ugly.
THE RISK OF COMPLICATIONS
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COMMON REASONS FOR RE-INTERVENTION
• Soft tissue redundancy
• Hyper granulation
• Peri-prosthetic fractures
• Implant /component
fractures
21
• Cable or Screw removal
• Neurectomy
• TKR/THR required due to
increased activity
• Safety pin breakage
In addition to the rate of infections and revisions, we
identified several additional factors:
METHOD
• Retrospective analysis on 497 cases performed by our
team between 2010-2017 with a min. 1 year follow-up.
• All complications requiring a re-operation were verified
through hospital records and pooled for analysis.
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PATIENT COHORT
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Patient Characteristics (N=301)
Gender 212 Males, 89 Females
Age at Sugery Avg: 47.49, Min: 20.37, Max: 83.95 (years)
Time Since Surgery Avg: 2.90, Min: 1.02, Max: 7.46 (years)
Amputation Level
Transfemoral: 219, Transtibial: 78,
Transhumeral: 4
Protocol Two Stage: 78, Single Stage: 223
Deaths 5 (all unrelated)
Exclusion: Young Age, Ongoing Smoking, Psychological instability & non-compliance.
Total: 301 cases identified with >1 year follow-up
76% EVENT FREE
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229 Patients = Event Free
76% of the 301 patients included in this analysis
5/12/2018
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5 MAJOR RE-OPERATION EVENT TYPES
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1. Infections requiring surgical debridement
2. Removal of neuromas
3. Redundant soft-tissue refashioning
4. Revision of implants for any reason
5. Peri-prosthetic fracture fixation
TOTAL RE-OPERATIONS (ALL CASES, N=301)
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DEBRIDEMENTS
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Total Debridement Cases (N=34)
Patients Single Episode: 24, 2nd Episodes: 9, 3rd Episodes: 1
Amputation
Level
TFA Count: 11 out of 219 cases Rate: 6.9%
TTA Count: 19 out of 78 cases Rate: 24.3%
THA Count: 0 out of 4 cases -
Protocol
2-stage Count: 16 out of 79 cases Rate: 20.23%
1-stage Count: 18 out of 222 cases Rate: 8.11%
NEURECTOMY
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Total Neurectomy Cases (N=32)
PatientsSingle Episode: 25, 2nd Episodes: 4, 5rd, 4th, 5th:
1 each
Amputation
Level
TFA Count: 29 out of 219 cases Rate: 13.24%
TTA Count: 3 out of 78 cases Rate: 3.85%
THA Count: 0 out of 4 cases -
Protocol
2-stage Count: 13 out of 79 cases Rate: 16.46%
1-stage Count: 20 out of 222 cases Rate: 8.56%
5/12/2018
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SOFT TISSUE REFASHIONING
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Total Re-fashion Cases (N=48)
Patients Single Episode: 35, 2nd Episode: 12, 3rd Episode: 1
Amputation
Level
TFA Count: 38 out of 219 cases Rate: 17.35%
TTA Count: 1 out of 78 cases Rate: 1.28%
THA Count: 1 out of 4 cases Rate: 25.00%
Protocol
2-stage Count: 13 out of 79 cases Rate: 32.91%
1-stage Count: 19 out of 222 cases Rate: 6.31%
Female patients have 2x the rate of refashions
PERI-PROSTHETIC FRACTURES
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Total Peri-prosthetic Fracture Cases (N=10)
Patients Single Episode: 10
Amputation
Level
TFA Count: 10 out of 219 cases Rate: 4.57%
TTA Count: 0 out of 78 cases -
THA Count: 0 out of 4 cases -
Protocol
2-stage Count: 4 out of 78 cases Rate: 5.06%
1-stage Count: 6 out of 223 cases Rate: 2.70%
All fractures were secured without revising the implant
5/12/2018
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IMPLANT REVISION
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Total Revision Cases (N=23)
Patients Single Episode: 23
Amputation
Level
TFA Count: 10 out of 219 cases Rate: 4.57%
TTA Count: 12 out of 78 cases Rate: 15.38%
THA Count: 1 out of 4 cases Rate: 25.00%
Protocol
2-stage Count: 8 out of 78 cases Rate: 10.13%
1-stage Count: 15 out of 223 cases Rate: 6.76%
REVISIONS IN FEMURS (>1Y Follow-up)
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REVISIONS IN TIBIAS (>1Y Follow-up)
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FEMUR UNDER SINGLE STAGE (>1Y Follow-up)
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KAPLAN-MEIER IMPLANT SURVIVAL
ESTIMATES
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Study period 2010-2018
FEMUR N= 285, 92% @ 7 yrs
TIBIA N= 98, 85% @ 4 yrs
All complex cases excluded:
• OI+TKR
• OI+THR
• Humanitarian missions
• Limb lengthening
• PVD
• Diabetic
• Irradiated bone
• Non-standard implant
Total revisions = 16
StataCorp. 2017. Stata Statistical Software: Release 15. College Station, TX: StataCorp LLC
CONCLUSIONS
• Approximately 76% of all patients were event free while many of
the patients experienced recurring events.
• The risks for infections are much higher for TTA patients in
comparison to TFA patients. This is reflected in the rate of
debridements and revisions for TTA.
• Single-stage surgery greatly reduces the chances of Infections
requiring debridement, Refashioning and Revision rates.
• Limitations: Sampling Bias, Confounders, Sub-group analysis,
Expand into component complications.
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5/12/2018
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www.bestppt.com
The Sydney OGA team
Dr Solon Rosenblatt (Clinical Director)
Claudia Roberts (Clinical Coordinator)
Dr William Lu (Chief Researcher)
A/Prof Munjed Al Muderis (Orthopaedic
Surgeon)
Stefan Laux and APC Prosthetics
Dr Chris Basten (Amputee Psychologist)
Dr Kevin Tetsworth (Orthopaedic Surgeon)
Dr Ajay Kumar (Anaesthetist)
Dr Tim Ho (Pain Specialist)
Dr Geoff Booth (Rehabilitation Physician)
Emma Crozier (Physiotherapist)
Dan Gerbec (Engineer)
Dr. Valerio Taraschi (Engineer)
Dr Orville Samuel (Orthopaedic Fellow)
Dr Shakib Jawazneh (Orthopaedic Fellow)
Seamus Thomson (PhD Student)
Cassandra Cunningham (Manager)
The Perth team
A/Prof Richard Carey Smith (Orthopaedic
Surgeon)
Andrew Vering (Prosthetist)
The Melbourne team
Dr Selva Mudailer (Rehabilitation Physician)
Dr Andrew Bucknell (Orthopaedic Surgeon)
Mark Graff (Prosthetist)
The Adelaide team
Dr Tom Savvoulidis (Orthopaedic Surgeon)
The UK team
Dr Rhodri Phillip (Rehabilitation Physician)
Mr Jon Kendrew (Orthopaedic Surgeon)
Norbert Kang (Plastic Surgeon)
Mark Thoburn (Prosthetist)
Matthew Hughes (Prosthetist)
Moose Baxter (Prosthetist)
Kate Sherman (Physiotherapist)
The New Zealand team
Dr John McKie (Orthopaedic Surgeon)
Graham Flanagan (Prosthetist)
The US team
Dr Robert Gailey (Physiotherapist)
Dr Danielle Melton (Rehabilitation Physician)
Dr. Robert Rozbruch (Orthopedic Surgeon)
The Canadian team
Dr Robert Turcotte (Orthopaedic Surgeon)
Dr Natalie Habra (Physiatrist)
Laura Casu (Physiotherapist)
Catherine Valle (Prosthetist)
The Taiwanese team
Dr Tai-Sheng Tan (Orthopedic Surgeon)
Zheng-Rong Zhang (Trauma Surgeon)
Dr Chien Lun (Rehabilitation Physician)
Professor Min-chun Pan(Biomedical
Engineer)
Acknowledgements
The Dutch team
Dr Oscar J.F. van Waes (Trauma Surgeon)
Dr Heleen De Graaff (Orthopedic Assistant)
Dr Jan Paul Frolke (Trauma Surgeon)
Dr Henk Van De Meent (Rehabilitation
Physician)
Prof J.A Jansen (Research)
M. Papenburg (Prosthetist)
The German team
A/Prof Ludger Gerdesmyer (Orthopaedic
Surgeon)
The Jordanian team
A/Prof Khaled Ata (Orthopaedic Surgeon)
Mohammed Awad (Engineer)
The Israeli team
Dr. Hagay Amir (Orthopedic Surgeon)
Dr. Steven Velkes (Orthopedic Surgeon)
The Polish team
Dr Wojtek Piwek (Orthopaedic Surgeon)
Maciej Michalski (Engineer)
The South African team
Dr Nando Dr Nando Ferreira (Tumour
Surgeon)
Eugene Rossouw (Orthotist and Prosthetist)
Fransien Heymann (Physiotherapist)
And many more…
www.bestppt.com
WILLIAM LU, PhD
Mobile: +61 (0) 468 805 858
OSSEOINTEGRATION GROUP OF AUS
Suite G3B, 11 Norbrik Drive
Bella Vista NSW 2153, Australia
OSSEOINTEGRATION INTERNATIONAL INC.
9120 Double Diamond Parkway
Reno, NV 89521, USA
GET IN TOUCH
THANK YOUQUESTIONS?
5/12/2018
18
www.bestppt.com
Osseointegration:
Rates of Complication
& Re-operations
William Lu, PhD
Clinical Researcher,
The Osseointegration Group of Australia
Image Credit: Salehin Chowdhury @500px
DISCLOSURES
All patients gave consent prior to this presentation for the use of their
clinical data, images and videos.
The medical devices shown in this presentation is TGA and CE approved
for sale in the Australian, and European market. The medical devices
shown in this presentation is NOT FDA approved for sale in the US market.
I declare research interests in products mentioned. Research funding is
provided by the Australian Research Council (ARC) and Osseointegration
International Pty Ltd.
43
5/12/2018
19
THE JOURNEY OF OGA
44
•Utilised the press fit implant design
•Employed the guillotine amputation
technique
•Established a university based
multidisciplinary team
•Designed the implant
•Refined the surgical techniques
•Implemented a clinical data registry
•Introduced an infection classification
and monitoring system
OSSEOINTEGRATED PROSTHESES
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Eliminating Persistent Socket Issues
5/12/2018
20
OSSEOINTEGRATION PROSTHETIC LIMB (OPL)
46
WORLDWIDE OI PATIENT COHORT and partners
47
570 Osseointegration Cases Performed by OGA
750+Cases
Performed
Worldwide
5/12/2018
21
PUSHING THE ENVELOPE OF OI
THE OGAAP-2 SINGLE STAGE PROTOCOL
49
The Single Stage Approach
• Surgery: Press-fit of the intra-medullary component, Stoma
Creation & Installation of most components
• Rehabilitation commences: day 1 post-surgery
Single
Surgery}
5/12/2018
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AUSTRALIAN AMPUTATION STATISTICS
54
Dillon MP, Fortington LV, Akram M, Erbas B, Kohler F (2017)
Geographic Variation of the Incidence Rate of Lower Limb Amputation
in Australia from 2007-12. PLoS ONE 12(1): e0170705.
https://doi.org/10.1371/journal.pone.0170705
5 years Lower Limb Data
(from 2007–8 to 2011–12)
AUSTRALIAN AMPUTATION STATISTICS
55
Dillon MP, Fortington LV, Akram M, Erbas B, Kohler F (2017)
Geographic Variation of the Incidence Rate of Lower Limb Amputation
in Australia from 2007-12. PLoS ONE 12(1): e0170705.
https://doi.org/10.1371/journal.pone.0170705
5 years Lower Limb Data
(from 2007–8 to 2011–12)
More than half of our lower limb amputations associated with Diabetes
Traditionally excluded from OI
5/12/2018
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OSSEOINTEGRATION IN DIABETIC AMPUTEES
A case series of eight patients.
RATIONALE FOR TAKING ADDITIONAL RISKS
57
END STAGE
PVD / DM
Nearly half of the individuals who have an amputation
due to vascular disease will die within 5 years.
This is higher than the five year mortality rates for
breast cancer and prostate cancer.
Robbins JM, Strauss G, Aron D, Long J, Kuba J, Kaplan Y. Mortality rates and diabetic foot
ulcers: is it time to communicate mortality risk to patients with diabetic foot ulceration?.
Journal of the American Podiatric Medical Association. 2008 Nov;98(6):489-93.
5/12/2018
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RATIONALE FOR TAKING ADDITIONAL RISKS
58
Of persons with diabetes who have a lower
extremity amputation, up to 55% will require
amputation of the second leg within 2‐3 years.
Pandian G, Hamid F, Hammond M. Rehabilitation of the Patient with Peripheral
Vascular Disease and Diabetic Foot Problems. In: DeLisa JA, Gans BM, editors.
Philadelphia: Lippincott‐Raven; 1998.
HYPOTHESIS
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Low Mobility
Lifestyle
Vascular
Disease
Amputation
Failed
Rehabilitation
5/12/2018
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HYPOTHESIS
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Low Mobility
Lifestyle
Vascular
Disease
Amputation
Failed Socket
Rehabilitation
Osseointegration
Improved
Mobility & QoL
Controlled Disease
• 3 Trans-tibial Amputees and 5 Trans-femoral Amputees
• 6 Males and 2 Females
•Age range from 46.0 – 71.96 years (Avg. 61.19)
• 2 were Overweight and 6 were Obese
All had underlying diabetic conditions that were under appropriate control.
HbA1c < 7
PATIENT DEMOGRAPHICS
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PATIENT EXAMPLE 1 (L.B.)
63
Fracture @ 9M 3M Post Fracture 3 Yr Review
PATIENT EXAMPLE 2 (R.I.)
64
Pre-OP 3 Post-OP Loosening @ 2Y
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PATIENT EXAMPLE 3 (R.M.)
65
2Y Review1Y Review
2Y Review
PATIENT EXAMPLE 3 (R.M.)
5/12/2018
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SUMMARY
67
• 6/8 were wheelchair bound, now all ambulating with their Osseointegrated
prosthesis.
• All patients improved in QoL (Q-TFA, SF-36) and mobility scores (6MWT, TUG).
Adverse events:
• 1 Fracture due to fall.
• Minor infection were common but easily managed through oral antibiotics.
• 2 Patients developed an deeper infection that required surgical debridement.
• 1 Implant revision due to aseptic loosening
• 1 Patient also required a neurectomy and soft-tissue refashioning procedure.
CONCLUSION
68
Patients with diabetic conditions are normally excluded from Osseointegration
surgery.
However, the experiences from our centres demonstrated that amputees with
controlled diabetic conditions are able to benefit from Osseointegration with
reasonable rates of adverse events.
The improved Quality of Life and Mobility may also in turn provide a protective
effect against their underlying diabetic conditions.
5/12/2018
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BIO-INTERFACING: TMR
71
www.bestppt.com
The Sydney OGA team
Dr Solon Rosenblatt (Clinical Director)
Claudia Roberts (Clinical Coordinator)
Dr William Lu (Chief Researcher)
A/Prof Munjed Al Muderis (Orthopaedic
Surgeon)
Stefan Laux and APC Prosthetics
Dr Chris Basten (Amputee Psychologist)
Dr Kevin Tetsworth (Orthopaedic Surgeon)
Dr Ajay Kumar (Anaesthetist)
Dr Tim Ho (Pain Specialist)
Dr Geoff Booth (Rehabilitation Physician)
Emma Crozier (Physiotherapist)
Dan Gerbec (Engineer)
Dr. Valerio Taraschi (Engineer)
Dr Orville Samuel (Orthopaedic Fellow)
Dr Shakib Jawazneh (Orthopaedic Fellow)
Seamus Thomson (PhD Student)
Cassandra Cunningham (Manager)
The Perth team
A/Prof Richard Carey Smith (Orthopaedic
Surgeon)
Andrew Vering (Prosthetist)
The Melbourne team
Dr Selva Mudailer (Rehabilitation Physician)
Dr Andrew Bucknell (Orthopaedic Surgeon)
Mark Graff (Prosthetist)
The Adelaide team
Dr Tom Savvoulidis (Orthopaedic Surgeon)
The UK team
Dr Rhodri Phillip (Rehabilitation Physician)
Mr Jon Kendrew (Orthopaedic Surgeon)
Norbert Kang (Plastic Surgeon)
Mark Thoburn (Prosthetist)
Matthew Hughes (Prosthetist)
Moose Baxter (Prosthetist)
Kate Sherman (Physiotherapist)
The New Zealand team
Dr John McKie (Orthopaedic Surgeon)
Graham Flanagan (Prosthetist)
The US team
Dr Robert Gailey (Physiotherapist)
Dr Danielle Melton (Rehabilitation Physician)
Dr. Robert Rozbruch (Orthopedic Surgeon)
The Canadian team
Dr Robert Turcotte (Orthopaedic Surgeon)
Dr Natalie Habra (Physiatrist)
Laura Casu (Physiotherapist)
Catherine Valle (Prosthetist)
The Taiwanese team
Dr Tai-Sheng Tan (Orthopedic Surgeon)
Zheng-Rong Zhang (Trauma Surgeon)
Dr Chien Lun (Rehabilitation Physician)
Professor Min-chun Pan(Biomedical
Engineer)
Acknowledgements
The Dutch team
Dr Oscar J.F. van Waes (Trauma Surgeon)
Dr Heleen De Graaff (Orthopedic Assistant)
Dr Jan Paul Frolke (Trauma Surgeon)
Dr Henk Van De Meent (Rehabilitation
Physician)
Prof J.A Jansen (Research)
M. Papenburg (Prosthetist)
The German team
A/Prof Ludger Gerdesmyer (Orthopaedic
Surgeon)
The Jordanian team
A/Prof Khaled Ata (Orthopaedic Surgeon)
Mohammed Awad (Engineer)
The Israeli team
Dr. Hagay Amir (Orthopedic Surgeon)
Dr. Steven Velkes (Orthopedic Surgeon)
The Polish team
Dr Wojtek Piwek (Orthopaedic Surgeon)
Maciej Michalski (Engineer)
The South African team
Dr Nando Dr Nando Ferreira (Tumour
Surgeon)
Eugene Rossouw (Orthotist and Prosthetist)
Fransien Heymann (Physiotherapist)
And many more…
5/12/2018
31
www.bestppt.com
WILLIAM LU, PhD
Mobile: +61 (0) 468 805 858
OSSEOINTEGRATION GROUP OF AUS
Suite G3B, 11 Norbrik Drive
Bella Vista NSW 2153, Australia
OSSEOINTEGRATION INTERNATIONAL INC.
9120 Double Diamond Parkway
Reno, NV 89521, USA
GET IN TOUCH
THANK YOUQUESTIONS?