Home Archive Vol 36, No.2, 2010 Original papers Data on Endoprosthetic Hip Replacement in Romania, in the Period 2003-2010

Data on Endoprosthetic Hip Replacement in Romania, in the Period 2003-2010

 C. V. PUIA, C. POLINICENCU

“Iuliu Haţieganu” University of Medicine and Pharmacy, Cluj-Napoca

ABSTRACT Endoprosthetic hip replacement is a reconstructive surgery procedure for the prosthetic replacement of the hip joint components. The aim is to restore the joint mobility and normal function of all periarticular structures that control the joint motion, allowing operated patients to live a normal life. The paper aims to present the situation of endoprosthetic hip replacements in Romania from 2003 to the present, including the number of interventions performed (primary and revision surgery), their costs, the main types of implanted prostheses, the sex distribution of endoprosthetic replacements, the reporting and recording procedures of the interventions performed. All Romanian citizens who have a medical insurance benefit from prostheses free of charge. As the demand for endoprostheses is very high and the allocated funds are insufficient, patients are placed on waiting lists. Part of these, who can no longer wait, pay for their prostheses. There are no separate data on patients paying for their prostheses and those benefiting from them free of charge. The existing data only refer to the total number of endoprosthetic replacements performed.

KEY WORDS National Endoprosthesis Register, endoprosthetic hip replacement, costs


Introduction

An endoprosthesis is a medical device placed inside the body in order to permanently replace a bone, vessel or heart valve segment [1]. The endo-prostheses used in orthopedics can be classified according to:

▪ the replaced joint: hip, knee, shoulder, elbow, spine;

▪ the replaced joint part: partial or total pros-thesis;

▪ the type of bone fixation: cemented and unce-mented, with or without antibiotic.

Endoprosthetic hip replacement is a recons-tructive surgery procedure for the prosthetic repla-cement of the joint components in this area of the body. The aims of endoprosthetic hip replacement are: to alleviate the suffering of the patient through the elimination of symptoms, mainly pain, to restore joint mobility and stability, and finally, to improve the patient’s quality of life.

Considering the fact that the joint under the greatest amount of stress and the most affected by degenerative diseases is the hip, the majority of the prostheses implanted in Romania and worldwide are hip endoprostheses, followed by knee endoprostheses. There are two types of hip prostheses: cemented and uncemented. Uncemen-ted prostheses are fixed directly to the bone, while cemented prostheses are fixed with cement. 
The latter are indicated for elderly people, because these have a poorer bone quality, which does not allow direct fixation. The disadvantage of a cemented prosthesis is that it is very difficult to change (revise) after it wears out, which is why it is not recommended for young people, who need to have their prostheses replaced several times during the course of life. The price of a cemented prosthesis is lower than that of an uncemented prosthesis: 600–1000 euros compared to 1200–1500 euros.

Although a great number of endoprosthetic replacements are performed in Romania, public information on the number of these interventions, the costs involved, the types of prostheses used is not widely available. We aimed to research this issue based on the literature data, in order to offer a general view on the subject.

Material and Methods

In order to have an accurate image of the situa-tion of endoprosthetic replacements in Romania, we studied the literature, using in particular the information provided by the Ministry of Public Health, theNational Health Insurance House
the National Endoprosthesis Register and the materials offered by endoprosthesis suppliers.

The exploratory research and the logical analysis of data were used as working methods.

Results and Discussion

In Romania, there is a National Endoprosthesis Program by which the Ministry of Public Health and the National Health Insurance House ensure the funds required for the acquisition of endo-prostheses. This program started in 2001, by the Romanian Government Decision No. 561/2001 [2], being initially entitled “Prevention in orthopedics and traumatology; orthopedic prosthetics – adults and children (PN 20)”. The program led to the creation of the National Endoprosthesis Register, an extremely important document for the recor-ding of all interventions performed in orthopedic services in Romania. In this register, the data regarding the interventions performed are public, but the data on patients are confidential [3]. 
At present, the National Endoprosthesis Register has records for approximately 55 000 patients with primary and revision hip endoprostheses [3].

The situation of hip endoprostheses from 2003 to the present (1st semester of 2010) is shown in Figures 1–4 [3].

Figure 1 – Number of hip endoprosthesis, 
in Romania, during 2003–2010.

According to the data shown in Figure 1, from 2003 to the present, 55 810 hip endoprostheses were implanted, of which 52 727 primary hip endoprostheses (94.48%) and 3083 revision endo-prostheses (5.52%). During 2003–2010, a continu-ous increase occurred, with a maximum in 2008.

Figure 2 – Hip primary joint surgeries by endoprosthesis type, in Romania, 
during 2003–2010.

The data of Figure 2 show that in the studied period, the most demanded prostheses were 
total prostheses (34 925 operations), representing 66.69% of the total number, followed by Moore prostheses (14 303 operations), 27.31%, and bi-polar prostheses (3145 operations), representing only 6% of the total number. In the evolution in time, during the eight years, an annual increase in the number of total hip endoprostheses, a slight decrease in the number of Moore prostheses, and a relatively constant number of bipolar prostheses can be seen.

Figure 3 – Hip primary joint surgeries – sex distribution, in Romania, during 2003–2010.

Sex distribution (Figure 3) indicates a clearly higher number of endoprosthetic replacement cases in the female sex (59%), compared to the male sex (41%), this percentage being relatively constant over the researched period.

Figure 4 – Hip primary joint surgeries by fixation, 
in Romania, during 2003–2010.

Figure 4 shows that in the period 2003–2010, of a total number of 34 925 implanted hip pros-theses, 23 371 were total cemented prostheses (66.91%), 10 793 total uncemented prostheses (30.90%), and 762 were hybrid or reversed hybrid prostheses (2.18%). The evolution in time shows a constant increase in the number of total uncemen-ted prostheses (from 28% in 2003, to 46.43% in 2009), and relatively constant numbers for the other categories: total cemented and hybrid pros-theses.

The National Endoprosthesis Register surveys the quality of the implanted endoprostheses and detects defective endoprostheses. The information regarding this aspect is included in the forms completed and reported by orthopedists [3].

The interventions are reported to the National Endoprosthesis Register by the orthopedic servi-ces in the country based on two types of forms:

1. Type 0/1 form, which is sent monthly and includes information on the number of endo-prosthetic procedures performed, the types of prostheses used, the average costs regarding endoprosthetic replacement, the treated pathology, as well as the efficiency indicators established by the Ministry of Public Health and the National Health Insurance House. This form does not include information regarding hospitalization, medication and cement [4].

2. Individual patient forms type 2a (primary implant), 3a (revision implant), which are reported after each intervention and contain information on the patient and the type of implanted or revised prosthesis [5–6].

All Romanian citizens who have a medical insurance benefit from prostheses free of charge. The demand is very high and the funds allocated to endoprostheses are not sufficient to cover all the annual demands, so that when these funds are exhausted, patients have two possibilities: to join the waiting lists or to pay for their endoprostheses.

There are no data available as public infor-mation from official statistical records regarding the number of patients placed on waiting lists or the number of patients paying for their endopros-theses from their own resources.

The only data available from the official nor-mative documents are those published by the legal regulations regarding national health programs, among which the National Endoprosthesis Pro-gram occupies an important place.

The data shown in Figures 5–7 are information collected from the Romanian Official Monitor regarding the development of national health pro-grams in the period 2003–2010 [7–14].

Figure 5 – Funds for the Arthroplasty National Program, during 2003–2010.

From Figure 5 it can be seen that the sums allocated to the National Endoprosthesis Program constantly increased during the first six years of this program, being two times higher in 2008 compared to 2003. This increase was influenced by several factors, such as the increasing number of specialists in endoprosthetic replacement, of endoprosthetic techniques, as well as of patients with an indication for this type of intervention. Starting with 2008, in the context of the economic crisis, these funds began to diminish.

The number of patients included in the National Endoprosthesis Program, as shown in Figure 6, constantly increased until 2008, being approxima-tely five times higher in 2008 compared to 2003.

Figure 6 – Number of patients Included in the Arthroplasty National Program, 
during 2003–2010.

Based on the indicators reported as part of the National Endoprosthesis Program, the calculation of a realistic mean cost per endoprosthesis patient was possible, and as shown in Figure 7, this was significantly reduced, from 1711 euros in 2003 to 700 euros in 2010.

Figure 7 – Average cost/patient (in euros), 
during 2003–2010.

Prostheses are acquired by hospitals following auctions. The quality of the acquired prostheses is decided by the hospital, depending on the funds allocated as part of the health program. In Romania, no endoprostheses are manufactured. These are imported from important prosthesis manufacturers in Europe and USA. A hip prosthesis is formed by a cotyloid component that is fixed to the pelvis and is termed cup, another component that is fixed to the femur and is termed stem (tail), and a motion component, the spherical head. The sphe-rical head is usually made of ceramic material, the stem is made of metal or titanium-based alloys (e.g., Elite, Exeter, Filler, TTH, UTAA, etc.), and the cup is made of special polyethylene (Azur, Swing, Apogee, Igloo, etc.), metal or alloys (titanium). The highest performance, but also most expensive, are endoprostheses entirely made of alloys with a ceramic head. They have a longer durability (up to 25 years), according to manufac-turers, and are more stable. Prostheses can be cemented or uncemented. Uncemented prostheses are intended for young patients, while cemented prostheses, for older people. In the case of cemen-ted prostheses, orthopedic cement is used for fixa-tion, with or without antibiotic (e.g. gentamycin). Manufacturers make efforts to produce effective, solid and long lasting prostheses, with a compo-nent design reproducing as close as possible the joint architecture.

According to the data provided by the National Endoprosthesis Register, in Romania, of the 134 hospitals recorded, only 71 perform endoprosthetic hip replacement procedures [15].

Conclusions

1. The paper presents the situation of endopros-thetic hip replacements performed in Romania, 
in the period 2003–2010 (1st semester).

2. In Romania, endoprosthetic hip replacements are performed as part of the National Endopros-thesis Program, all interventions being recorded 
in the National Endoprosthesis Register. Citizens who have a medical insurance benefit from prostheses free of charge. However, because funds prove to be insufficient, patients are placed on waiting lists. Patients also have the possibility to pay for their prostheses.

3. From 2003 to 2010 (1st semester), 55 810 hip prostheses were implanted, 94.5% being primary hip endoprostheses and only 5.5% revision endo-prostheses.

4. The sex distribution of hip endoprostheses is clearly in favor of women (59%), compared to men (41%).

5. Although the number of cemented prostheses is still greater than that of uncemented prostheses, the number of uncemented prostheses is conti-nuously increasing, so that the number of the two types of prostheses will soon be equal.

6. The sums allocated to the National Endo-prosthesis Program doubled in 2008 compared to 2003, and the number of operated patients increa-sed five times. This became possible due to a more than 50% reduction of the costs of an endo-prosthesis patient compared to 2003, through an increase in the number of specialists in endo-prosthetic replacement, an improvement in pros-thetic techniques and an increased offer of endo-prostheses on the Romanian market.

References

1.     *** – (2010), http://dictionar.romedic.ro/endoproteza, 12.07.

2.     *** – (2001) Romanian Government Decision No. 561/2001 for the approval of health programs finan-ced in 2001 from the budget of the Ministry of Health and Family and from the budget of the social health insurance fund, The Official Monitor, Part I, No. 334.

3.     *** – (2010) http://www.rne.ro/site/despre_1_default. aspx, 13.07.

4.     *** – (2010) http://www.rne.ro/site/download/forms/ RNE_01_Formular_Tip0-1.pdf, 13.07.

5.     *** – (2010) http://www.rne.ro/site/download/forms/ RNE_02_Formular_Tip2a_SoldPrimar.pdf, 13.07.

6.     *** – (2010) http://www.rne.ro/site/download/forms/ RNE_03_Formular_Tip3a_SoldRevizie.pdf, 13.07.

7.     *** – (2010) Order of the Ministry of Health and of the President of the National Health Insurance House No. 264/407/01.04.2010 for the approval of the tech-nical norms for the development of national health programs in 2010, published in the Official Monitor No. 205/01.04.2010, with subsequent changes.

8.     *** – (2009) Order of the Ministry of Health and of the President of the National Health Insurance House No. 417/431/31.03.2009 for the approval of the tech-nical norms for the development of national health programs in 2009, published in the Official Monitor No. 211/01.04.2009, with subsequent changes.

9.     *** – (2008) Order of the Ministry of Public Health and of the President of the National Health Insurance House No. 574/269/31.03.2008 for the approval of the technical norms for the development of national health programs in 2008, published in the Official Monitor No. 258/02.04.2008, with subse-quent changes.

10. *** – (2007) Order of the Ministry of Public Health and of the President of the National Health Insurance House No. 570/116/29.03.2007 for the approval of the technical norms regarding the evaluation, implementation and financing of national health programs, the responsibilities for their monitoring and control, the presentation of subprograms and activities, the specific indicators, as well as the health units developing these programs in 2007, published in the Official Monitor No. 212/28.03.2007, with subsequent changes.

11. *** – (2006) Order of the Ministry of Health and of the President of the National Health Insurance House No. 385/161/11.04.2006 for the approval of the development of the national program and subprograms with curative intent, financed from the budget of the national social health insurance fund in 2006, published in the Official Monitor No. 433/ 09.05.2006, with subsequent changes.

12. *** – (2005) Order of the Ministry of Health and of the President of the National Health Insurance House No. 55/42/03.02.2005 for the approval of the deve-lopment of the health program and subprograms financed from thebudget of the national social health insurance fund in 2005, published in the Official Mo-nitor No. 128/10.02.2005, with subsequent changes.

13. *** – (2004) Order of the Ministry of Health and of the President of the National Health Insurance House No. 172/113/18.02.2004 for the approval of the health programs and subprograms financed from the state budget and the budget of the national social health insurance fund in 2004, published in the Official Mo-nitor No. 214/11.03.2004, with subsequent changes.

14. *** – (2003) Order of the Ministry of Health and of the President of the National Health Insurance House No. 248/149/21.03.2003 for the approval of health subprograms in 2003, published in the Official Moni-tor No. 242/09.04.2003, with subsequent changes.

15. *** – (2010) http://www.rne.ro/site/spitale_4_lista_ spitale.aspx,14.07.

 

 

 

Correspondence Adress: Cristian Vasile Puia, MD, “Iuliu Haţieganu” University of Medicine and Pharmacy, Cluj-Napoca, e-mail: cristianpuia2@yahoo.com

 


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