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| ORIGINAL ARTICLE |
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| Year : 2017 | Volume
: 5
| Issue : 1 | Page : 44-47 |
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Study of properties of explanted implant with view to reuse
Sethi Kailash1, Golwala Paresh2
1 Professor, Department of Orthopedic Surgery, Smt. B. K. Shah Medical Institute and Research Center, Sumandeep Vidyapeeth, Piparia, Waghodia, Vadodara, Gujarat, India
2 Professor & HOD, Department of Orthopedic Surgery, Smt. B. K. Shah Medical Institute and Research Center, Sumandeep Vidyapeeth, Piparia, Waghodia, Vadodara, Gujarat, India
| Date of Web Publication | 30-Aug-2018 |
Correspondence Address:
Golwala Paresh
Professor & HOD, Department of Orthopedic Surgery, Smt. B. K. Shah Medical Institute and Research Center, Sumandeep Vidyapeeth, Piparia, Waghodia, Vadodara, Gujarat
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/2347-6486.240225
Introduction: Increasing number of implants is in use for treatment of fracture to get better results. Poor people are more prone to fractures but they are unable to afford these implants. On other hand, explants (removed implants) are not allowed to be reused by law. So why not to reuse suitable explants to alleviate the suffering, which will help these poor patients.
Method: Implants were explanted from patients with clinical indication after voluntary consent. They were submitted to microbiological (in microbiology lab), mechanical and metallurgical (by Brinell hardness Machine and under Scanning Electronic Microscope) tests before and after minor modifications in vitro.
Results: The properties of explants after minor modifications were compared with properties of new implants and were found to be same.
Conclusion: As results are excellent in vitro, now it is high time to test the efficacy of explants in vivo so they can be reused in future patients if found good. This will help economically deprived patients and their families to a great deal. This will also reduce Bio Medical Waste (BMW). This research project is funded by Sumandeep Vidyapeeth, Piparia, Vadodara.
Keywords: Implants, Explants, BMW, SEM, Corrosion, Sonication
How to cite this article:
Kailash S, Paresh G. Study of properties of explanted implant with view to reuse. J Integr Health Sci 2017;5:44-7 |
| Introduction | |  |
Majority of orthopedic surgeons are using modern and costly implants for the treatment of fractures to get better result. When they are removed for any reason, they are known as explants. Explants are discarded to dustbin and subsequently to landfill as non disintegrable biomedical waste (BMW), which also deteriorates environment.[1]
In general, incidence of fracture is on increase and more so in poor people.[2] More than 1/3rd population lives below poverty line.[3] If a fracture occurs, they often have to refuse urgently needed treatment and will suffer from increased morbidity, disability as the sequelae of fractures due to poverty.[4]
On other hand, the reuse of explants is prohibited by law.5 If reuse of suitable explants is allowed, then it will be of great help to these patients, and they will soon be a productive member of society. This will reduce the use of natural resources and biomedical waste (BMW).
This study was done to assess if it would be fruitful to rethink about reuse of expiants to help poor patients. Before reusing, expiants have to be put to many scientific tests, to assess their feasibility to reuse, but it should be without compromising the results. This is not a money saving exercise at the cost of quality and final outcome. So one has to study the biological, mechanical and metallurgical properties of explants and compare them with the properties of new implants, in vitro to start based on following parameters[6] -
- Any soft tissues and bone changes around the implant in situ.
- Surface finish (polish).
- Deformation of explant.
- Cracks in explants.
- Microbiological study after sterilization of explants.
- Hardness of explants.
- Composition of explants.
- Corrosion of explants.
To analyse the results.
To recommend or discard the results.
To note any complications during study period.
| Need of Study - | | |
This study is needed --
- To help poor patients, who are more prone to fracture of bone.
- To reduce BMW, so as to improve the environment.
This will lower the health care cost drastically in the treatment of fracture by the reuse of explants, if they are feasible.
| Methodology | | |
This vitro study includes forty four explants, made up of 316L stainless steel, which were collected from patients admitted to Dhiraj Hospital, Piparia, with clinical indication for explantation. Six new implants, made up of 316L stainless steel, were included for comparison.
This research study has been carried out at two universities after approval from ethical commity of Sumandeep Vidyapeeth.
- Department of Orthopedic Surgery, Sumandeep Vidyapeeth, Piparia, Vadodara.
- Material and metallurgy dept., Faculty of Technology & Engineering, The Maharaja Sayajirao University of Baroda, Vadodara.
Patients were admitted to orthopedic ward with clinical indication for explantation of implants from Sept. 2013 to Jan 2016. A detailed history and examination of patients were recorded. An informed voluntary consent was taken after detailed discussion about the purpose of the study. Necessary investigations (Blood, HCV, HbS Ag ,H1V and x-rays) were carried out to obtained fitness for operation.
Under appropriate anaesthesia, parts were prepared and draped under full aseptic conditions. 1mplants were removed surgically after noting the conditions of implant and surrounding tissues in situ.
The explants were washed under running tap water, then with a solution containing 0,3 gm chlorhexidine gluconate and3.0 gm cetrimide (Savlon) and again with water. Here gross physical appearance (deformation, cracks, scratch, corrosion etc.) of explants was noted. Only four explants (all plates) showed minor superficial scratches.
Then all fifty samples [44 explants and 6 new implants (3 plates and 3 nails)] were doubly wrapped and sterilized after coding. Then these samples were opened in microbiology department and culture swabs were taken from each sample under aseptic condition, and inoculated separately in Blood agar and McConkey agar for culture (for at least 24 hours at 37 degree centigrade). No microbes were grown from any samples.
Lastly, these samples were taken to metallurgy department of M S University for further analysis under following heads: | Table 1: Gross examination, hardness and Examination of samples under SEM (scanning electron microscope).
Click here to view |
On discussion with metallurgists it was decided that if all these explants had slight modifications as under, then explants may be as good as new implants[7]-
- High speed burring of all holes.
- Ultra sound cleaning with acetone (sonication).
- Polish by Diamond paste (a paste used by metallurgist to improve the finish of metal).
All these modified explants were reviewed again under S E M and no corrosion was found. Surface finish and scratches were much improved. And these explants are as good as new and can be used in place of new implants if law permits
| Discussion | | |
There have been a few studies in the past which studied and reported that the reuse of orthopaedic implants, intracardiac defibrillator and pacemakers was possible.[8],[9],[10] In present vitro study, the explants were tested by microbiologist and metallurgist, who have confirmed that these explants are sterile and are not capable of causing cross infection. Metallurgically these explants are as good as new after some modifications, which have casted meagre Rs. fifty per explant.[11]
All these observations were compared with that of new implants and concluded that these explants are as good as new implants and can be used in place of new implants if law permits.
This alleviates the myths and beliefs of orthopedic fraternity that explants are of poor quality or can leads to cross infection. These myths and belief have been fuelled by baseless propagandas by orthopedic implants manufacturers.[5]
| Conclusion | | |
- The present study in vitro has established excellent results and concludes that explants are as good as new implants after some modifications.
- So it is high time to confirm these findings in vivo before explants can be reused in routine practice (Future Plan).
- If proved it will certainly be a great help to future patients and their families.
- This is the first scientific study of its kind (bacteriological, mechanical and metallurgical tests) and has never been done in past either in vitro or in vivo.
| References | | |
| 1. | Transport Research Wing, Ministry of Road Transport and Highways. Road Accidents in India 2011. New Delhi: Ministry of Road Transport and Highways, Government of India; 2012.  |
| 2. | Krishnan M. India has the highest number of road accidents in the world. Deutsche Welle. 2010:1. |
| 3. | WHO. 2013. ISBN 978 92 4 156456 4. Retrieved 2014-10-03.”WH0 | World report on road traffic injury prevention.” |
| 4. | Panda S, Khaja S, Mohanty NK. A study on pattern of fatal injuries in road traffic accidents in costal belts of Orissa. Journal of Indian Academy of Forensic Medicine. 2009;31(4):354-9. |
| 5. | Magetsari R, Hilmy CR, van Horn JR, Busscher HJ, Verkerke GJ, van der Mei, HC. Use and reuse of orthopedic implants in developing countries. Journal of Biomedical Materials Research Part B: Applied Biomaterials.2004; 69B: 249–50. |
| 6. | Busam ML, Esther RJ, Obremskey WT. Hardware removal: Indications and expectations. The Journal of the American Academy of Orthopaedic Surgeons. Feb 2006;14(2):113-20. |
| 7. | “Timir S. Baman and others; Intra Cardiac Defibrillator Reutilization”. A study on 328 explanted ICD, published from Michigan University. |
| 8. | Magetsari R, Hilmy CR, van Horn JR, Busscher HJ, Verkerke GJ, van der Mei, HC. Use and reuse of orthopedic implants in developing countries. Journal of Biomedical Materials Research Part B: Applied Biomaterials.2004; 69B: 249–50. |
| 9. | Timir S. Baman and others; Intra Cardiac Defibrillator Reutilization”. A study on 328 explanted ICD, published from Michigan University. |
| 10. | Ananya Banerjee, Second-hand pacemakers bring new life to patients in Mumbai, Mumbai, Thursday; Oct 27 2011. This is first-of-its’s- kind pilot project in India. |
| 11. | Dr. Daniel Mascarenhas; article in “The Pulse”, April 3, 2014, “One Doctor’s mission to recycle pacemakers in India” to reuse them in poor patients. |
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