with Uncemented Implants
X. Flores S ´anchez, E. Guerra Farfan, J. Nardi Vilardaga
Department of Orthopaedics, Vall d’Hebron University Hospital, Barcelona, Spain
Introduction
We expose the experience of the Musculo-Skeletal Septic Pathology Unit (UPSAL) of the Vall d’Hebron University Hospital (HUVH) in the treatment of infection associ- ated with total hip arthroplasty, using the two-stage procedure with uncemented implants [6, 14, 23, 34, 51, 61].
Material and Methods
Between August 1972 and September 2002 the UPSAL treated 205 infections associ- ated with total hip arthroplasty (periprosthetic joint infection); 161 cases were pri- mary THA and 44 cases revisions.
These infected arthroplasties led to, until the end of 2002, 299 treatment options (Fig. 1) which included:
) Suppressive antibiotic treatment [5, 78, 110] n: 19 ) Debridement and cleaning of implants [16, 82] n: 36
) 1-stage revision [6, 8, 39, 82, 83, 101] n: 22
) 2-stage revision [7, 34, 61, 112] n: 57
) Girdlestone resection arthroplasty [12, 33] n: 129 ) Debridement of resection arthroplasty due to persistent infection n: 36 As can be observed in Fig. 1, in the early years the most frequent option was resection arthroplasty, this being justified by the type of patients treated: chronic stages which had been subject to multiple surgical procedures in the centres where the problem had originally arisen.
In more recent years, as a centre of reference, the predominant option was the two- stage revision arthroplasty. The case series reported and analysis of our previous results made it advisory. Until 1994 in UPSAL, with the one and two-stage revision techniques, using Buchholz cemented implants [6, 34, 99], one third of patients showed persistent infection, two thirds were resolved of their septic process, but 30 % showed an aseptic loosening in the follow-up within 6 years (average follow up 117.4 months).
In 1996 we started a two-stage treatment [14, 112] protocol using uncemented implants [22, 32, 67, 68, 86] in those cases with chronic infection, unknown or multi-
Fig. 1. Treatment options employed
Fig. 2. Sampling for anatomopathological and microbiological study on bone-implant or bone- cement interface level
resistant bacteria, loss of bone stock and failure of one-stage revision [15, 38, 51, 54, 63].
We utilized arthrocenthesis as well as bone-implant or bone-cement interface biopsy to improve the successful bacterial identification. This interface biopsy was carried out in the operating room as the first procedure, before the first-stage, with a percutaneous trocar guided with radiographic C-arm.
Fig. 3. (A) Right hip X-ray in a patient with recurrent septic activity following THR. Unremoved bone cement is visible. (B) Clinical aspect of the patient subject to several previous operations.
(C) Clinical aspect of the femoral osteotomy done to remove the remains of the cement mantle.
(D) Clinical aspect after removal of the cement mantle
After bacterial identification, the first open surgical procedure must include an extensive debridement of both soft and bone tissue and foreign material. In both cemented and uncemented prosthesis the debridement usually requires osteotomies (Fig. 3) and or drill holes possibly leading to fractures and false tracts which makes the subsequent cementing challenging [29, 35, 86, 94]. The osteomized or perforated bone makes pressurizing the cement impossible within the medullary canal already weakened by revision arthroplasty. Acrylic cement often escapes on to soft tissue which can lead to future complications (Fig. 4) [94].
Once the debridement is achieved antibiotic spacers, [53, 65] custom made in both form and antibiotic content [31, 73, 76] will release high concentrations of antibiotics
“in situ”. This spacer avoid the retraction of the periarticular tissues and allows walk- ing with crutches [9, 20, 48, 49, 50, 84, 97, 98, 104, 106]. We have little experience with preformed spacers for both technical and economic reasons [84], and have proceeded from after the first stage to the preparation of custom made “personalised” spacers in relation to antibiotic content (secondary to the previous identification of the bacte- ria). Once the PMMA cement and corresponding antibiotics are added (up to 4 g of antibiotic for every 40 g unit of acrylic cement) it is wrapped in a sheet of latex and place it into the residual cavity and pressing it so that it takes up all the defects, and finally with the proximal part of the femur correctly lined up with the limb (Fig. 5).
When the cement begins to harden we use Moore’s corkscrew in the centre of the spacer approaching through the rear of the hip: this technical detail eases the placing
Fig. 4. (A, B) X-ray of cement leakage to soft tissues due to the presence of bone defects at a acetab- ular (A) or femoral (B) level
and extraction of the spacer (Fig. 6). Once the plastic properties of the cement have disappeared and before the exothermic reaction happens, we remove the spacer until it cools and then reinsert it.
During the intermediate period between the first and second stage, approximately three months, the patient continues on antibiotic treatment. According to the litera- ture the duration of the treatment varies between 2 and 3 months [5, 23, 27, 58, 73, 78, 110]. We adopted the 3-month period (orally, if possible), as it is the length of treat- ment advised for chronic osteomyelitis [14, 34, 63, 91, 112, 113].
Fifteen days after of intermediate period, if the patient is stable clinically and labo- ratory values are normal, analytical nor nuclear imagines, we proceed to the second stage revision [1, 8, 35, 53]. Frozen sections are sent for analysis [2] to confirm there is no acute inflammation. If present a second debridement is carried out, tissue sam- ples taken and a new antibiotic-spacer inserted. If the frozen section is negative for acute inflammation we continue with revision arthroplasty using uncemented implants [26]. Published evidence suggests that these uncemented implants have bet- ter long-term survival in revision surgery [26]. Moreover, the use of cement can inhibit the cellular response mechanisms due to heat from polymethylmetacrylate, by depressing the quimiotaxis and fagocytosis of the polimorphonuclear leukocytes, as
Fig. 5. Different phases in custom made “personalized” spacer A “Ball” shaping of acrylic cement with antibiotics
B Fitting cement wrapped in a latex sheet C Closing of latex “sheet”
D Fitting in to the residual space and shaping with fingers
E Once the acrylic cement begins to harder it is removed without being deformed
F The exothermic reaction (temperature around 90 °C) is carried out outside the patient using a coolant
G Once cool and completely hardened it is fitted into the residual space H Clinical aspect of spacer “in situ”
Fig. 6. Technical detail, the screwed orifice achieved by inserting the tip of a Moore’s corkscrew, before the cement hardens completely. The use of Moore’s corkscrew in the second stage aids spacer removal. X-ray of spacer “in situ” taking up all of the residual space. The profile of the screwed hole that will aid its extraction is also visible
demonstrated by Petty [30, 74, 75], and others. The use of cemented arthroplasties can explain the growth of resistant organisms secondary to using antibiotic cement.
Methods
Since 1996 we have used this method of treatment in 44 hip arthroplasties associated with a chronic infected hip arthroplasty, and this series constitutes the basis of our study. There were 25 men and 19 women, with an average age of 64.2 years, ranging from 20 to 88. Forty-seven percent of patients presented with comorbidities (23 patients were classified as physiological type A, 18 as type B and 3 type C). Fifteen patients (34.1 %) had previous surgery before presenting to our institution.
The THA involved were 37 primary prosthesis (25 cemented, 5 uncemented and 7 hybrids) and 7 revision hip arthroplasties (5 cemented, 1 uncemented and 1 hybrid).
The type of infection was: in 5 cases type II (2 early and 3 haematogenous), the others type IV (37 late and 2 haematogenous).
The bacteria responsible was gram positive in 54.6 % of cases, gram negative in 31.8 %, polymicrobian infections were present in 6.8 % of cases, other bacteria and the absence of a positive culture made up the remaining 7 %.
Fig. 7. X-rays of the only case that showed reinfection A Primary total hip arthroplasty
B Periprosthetic infection, chronic stage, a reactive hyperostosis is noted C Spacer “in situ” after first stage of revision
D X-ray of the uncemented stem used in the second stage of revision total hip arthroplasty E After 10 months, thigh pain, alteration of specific analytic parameters and “endostic osteoly-
tic” and periostitis signs occurrence
F Biopsy of the osteolytic cavity using a trocar guided by computerized axial tomography. S. epi- dermidis is isolated, with the same resistance profile as in the original germ
G After six months antibiogram-based antibiotic treatment disappearance of clinical signs and normalisation of the endostic osteolytic image is achieved
Results
Results for the first 25 cases treated with two stage revision with a cementless prosthe- sis, from 1996 to 2002 are reported. Two patients have died for reasons unrelated to the septic process, and their implants revealed no evidence of infection. The remain- ing 23 patients had an average age of 61.2 years (ranging between 20 and 88), 13 women and 10 men.
An average follow up of 74.5 months (ranging between 47.5 and 125 months), 22 of 23 patients were free of infection (95.7 %). One patient (4.3 %) had a reactivation of the periprosthetic infection in the form of thigh pain, increased ESR and CRP. He had a positive bone scan 10 months after the second stage (Fig. 7). The bacteria identified from biopsy with trocar aided revealed the same characteristics as the bacteria responsible for the original infection (Staphylococcus epidermidis). After obtaining the corresponding sensitivity the patient received oral antibiotic treatment for a period of 6 months, resolving the clinical signs, serum parameters and radiographic and nuclear imagines. The success of the therapy is attributed to the antibiotic treat- ment and an uncemented implant with an absence of a second interface as would be in the case with a cemented implant.
With an average follow up of 6 years (74.5 months) [47], all patients still have their implants and no loosening has been observed.
The functional result according to the Merle – d’Aubigue – Postel scale [18, 19] was completely satisfactory with pain scoring 5.86 (ranging between 5 and 6), mobility 4.93 (ranging between 2 and 6) and aided walking 4.86 (ranging between 2 and 6).
Discussion
Appropriate treatment of periprosthetic infection needs to identify the bacteria and obtain its sensitivity to different antibiotics before performing any surgery. The cor- rect and systematic use of specific antibiotics after radical debridement surgery is fundamental in treating any residual bacterias which may exist in the surgical field.
Obtaining this information is also important in two stage revision, if antibiotic spac- ers are used [13, 40, 56], whether prefabricated [24, 25, 41] or personalised [37]. That is why in the periprosthetic infection treatment protocol we systematically include a first operation in our unit, aimed at obtaining tissue samples from bone-cement or prosthesis-bone interface, the area where the infectious process develops [107], with a percutaneous trocar and biopsy tweezers guided by radiographic C-arm. In this way we try to get better sensitivity and specificity than that obtained through joint aspira- tion, whose sensitivity ranged 55 % and 86 %, placing the specificity between 94 % and 96 % [3, 95]. Clearly this elementary action will be more important in the near future, when new microbiological techniques will allow us to more easily and system- atically isolated and cultivated bacteria in the stationary phase of growth cycle con- tainer in the slime [100]. Our treatment is aime at those germs and hill not is limited to planktonic forms. The differing sensitivity profile of the bacteria contained in the biofilms is responsable for the majority of failures [77, 102], as the coagulase-negative Staphylococcus is implicated in nearly all of them.
Two-stage replacement is the most frequently used method in THA infections, it must be considered the first choice procedure in acute cases with serious sepsis and which endanger the life of the patient. However, periprosthetic infection is often late to show itself in chronic form. Two-stage revision is indicated when: the bacteria res- ponsable is unknown; we deal with virulent bacterias; there is insufficient bone stock;
the patient presents associated systemic pathologies or has failed with one-stage revi- sion. For some authors [93] the existence of sinus tracks is a reason to indicate two- stage revision but we believe that their existence is a manifestation of the chronic
nature does not in itself require this response. A correct debridement which includes the sinus tracks is totally compatible with one-stage revision, if all the conditions for this technique are fulfilled.
For some authors [93] the existence of precarious host immunity and medical condi- tions and insufficient bone stock are contraindications of a two-stage revision and in such cases recommend the one-stage revision with cemented implants. In our opinion precisely such cases should be treated with two-stage revision as it offers a higher guar- antee of success in patients with a relative immunosuppression. It is also in situations of insufficient bone stock when associated surgery is needed, use of bone grafts and spe- cial implants, which are not indicated in one-stage revision. The use of cemented implants gives rise to precarious cementing due to a smooth implantation surface. Poor bone quality with cortical deficiencies and endostic sclerosis make long-term stability and implant survival less likely with cemented techniques. They are also associated with potential false ways and frequent femoral osteotomies carried out during debridement surgery. The use of cemented implants makes it impossible to repair the problem bio- logically, which may have a deleterious effect on the immune system and which may also become an inhibiting factor upon local defence mechanisms as we will mention later. A correct joint reconstruction should only be considered when the septic process has been eradicated [108]. However it is clear that the overall treatment strategy must be guided by the patient’s ability to tolerate surgical procedures and their projected lon- gevity [93]. Two- stage approach entails the morbidity associated with multiple surger- ies and prolonged immobilization, and may be unacceptable for frail older patients [27]. In these cases long-term suppressive oral antimicrobial therapy alone or definitive resection arthroplasty may be an acceptable option. With this latter procedure, success- ful eradication of infection can be achieved in 60 % to 100 % of cases [4, 10, 12].
Published evidence gathered recently in the literature by Sia and Colbs [93] is very demonstrative. Out of a total of 601 periprosthetic hip infections [26, 28, 34, 44, 55, 61, 69, 70, 72, 88, 92, 99, 105, 109, 112], two-stage revision provided 88 % of good results, 530 cases were free of infection whereas one-stage revision carried out in other 914 cases only obtained 77 % of good results freeing 701 patients from infection [6, 8, 11, 42, 43, 90, 101, 111].
The results published upon total prosthetic hip replacement surgery showed higher medium-term survival rates, when cementless implants were used. In his arti- cle, Fehring [26]checks implant survival in non-septic replacement surgery. Out of a total of 283 cases using cemented implants, 92 needed a second revision within 7 years, whereas in further 468 cases of revision for aseptic weakening those that used uncemented implants noted a 1.28 % (6 of 468) re-revision rate with the same follow- up as the previous group.
The success of the cemented techniques lies in the micro-interdigitation of cement within the cancellous structure of the femur, after a failed femoral arthroplasty leaves a sclerotic tube incapable of allowing such interdigitation. In replacement surgery a good femoral fixation using cemented techniques is not possible. For that reason uncemented distal fixation implants are used. Not using cement at a proximal level favours spontaneous biological repair and allows the use of bone grafts to restore its precarious stock.
Surgical debridement carried out in the first stage, it is origin of solutions of conti- nuity at level of proximal femur, in form of extended trocanteric osteotomies, to with-
draw the femoral implants or the cement used in its fixation, false tracts related to accidental perforations or even intraoperative fractures. None of these situations favours a correct cementation but are compatible with the use of cementless implants associated with reconstruction techniques with bone grafts.
The use of uncemented distal support implants associated with transosseous approaches and proximal femoral fractures allows the spontaneous reconstruction of the weakened proximal bone.
Published evidence suggests that these uncemented implants have better long- term survival in revision surgery [26]. Also, the use of cement can inhibit the cellular response mechanism due to heat from polymethylmetacrylate, by depressing the qui- miotaxis and fagocytosis of the polimorphonuclear leukocytes, as demonstrated by Petty [30, 74, 75], and others. The use of cemented arthroplasties can explain the growth of resistance organisms secondary to using antibiotic cement. Not using anti- biotic cement as an implant fixation method is, for some authors [96], a disadvantage as it means they can not use high doses of antibiotic “in situ” during the second stage of replacement. We believe that the use of antibiotic cement is unnecessary as the sep- tic process is clinically controlled and its use in the pathology which concerns us is still a potential problem since after some weeks the doses of antibiotic released have sub-therapeutic quantities and even favour the appearance of resistance. Thornes in its study of experimental infection [98] demonstrates that antibiotic-loaded bone cement offers an optimal surface for the colonization, and a prolonged exposure to antibiotics facilitates the appearance of resistance by mutation. Another negative aspect of polymethylmetacrylate as shown by Petty [74, 75] is the inhibition of local cellular defences, by depressing the quimiotaxis and fagocytosis of the polimorpho- nuclear leukocytes.
Conclusion
To correctly treat periprosthetic infection it is crucial to identify the bacteria and obtain its sensitivity to different antibiotics. The correct and systematic use of spe- cific antibiotics after radical debridement surgery is fundamental in treating any residual bacteria which may exist in the surgical field. Obtaining this information is also very useful, if antibiotic spacers [13, 40, 56] are used, whether prefabricated [24, 25, 41] or personalised [37] in the intermediary period between stages in two-stage prosthetic revision surgery in the septic prosthesis hip as it allows us to adapt the type of antibiotics mixed with the acrylic cement to the specific needs of each case.
The inclusion of a previous operation in our protocol, the biopsy of tissue samples from bone-cement or prosthesis-bone interface improves upon the traditional diag- nostic method, joint aspiration, in identifying the bacteria responsible for the septic process. The bacteria was not identified in less than 7 % of cases, substantially improving sensitivity and specificity of joint aspiration, whose scores ranged between 55 % – 86 %, and 94 % – 96 % respectively [3, 95]. This is possible because bacteria investigation is carried out in the area where the process is most active, the bone-cement or prosthesis-bone interface [107]. Also, the solid specimens obtained in this way allow for microbiological and anatomopathological investigation. Clearly this elementary action will be more important in the near future, when new microbi-
ological techniques will allow us to more easily and systematically isolate and culti- vate bacteria contained in the slime 100], ultrasounding the prosthetic components already forms part of normal practice in some centres, such as the Mayo Clinic. Our treatment will be aimed at these bacteria and will not be limited to their planktonic forms. Our only failure was related to the presence of a coagulase-negative Staphylo- coccus which is responsible for most failures in other series [77, 102].
For us two-stage replacement can be considered the gold standard. It is the most fre- quently used method in treatment of THA infections [26, 28, 34, 44, 55, 61, 69, 70, 72, 88, 92, 99, 105, 109, 112], and is also the procedure of choice in acute cases which show seri- ous and systemic sepsis and endanger the patient’s life. However, periprosthetic infec- tion is often late to show itself in chronic form. Two-stage revision is indicated when:
the bacteria responsable is unknown; we deal with virulent bacteria; there is insuffi- cient bone stock; the patient presents associated systemic pathologies or has failed with one-stage revision. The published literature shows clearly that out of a total of 601 peri- prosthetic hip infections [26, 28, 34, 44, 55, 61, 69, 70, 72, 88, 92, 93, 99, 105, 109, 112], two-stage revision provided 88 % of good results, 530 cases were free of infection, whereas one-stage revision carried out in another 914 cases only obtained 77 % of good results freeing 701 patients from infection [6, 8, 11, 42, 43, 90, 93, 101, 111].
Two-stage replacement is also especially indicated in those cases with precarious host immunity and medical conditions, since this method offers a higher guarantee of success in patients with a relative immunosuppression. It is also a safe procedure in situations of insufficient bone stock where associated reconstructive surgery is needed, use of bone grafts and special implants, none of which are indicated in one- stage revision.
We obtained excellent results in terms of infection resolution, with an average fol- low up of 74.5 months; with 95.7 % of patients (22 of 23 cases) showing no relapse.
The advantages of uncemented implants are that they have the potential long-term fixation in a revision situation; the longer duration of uncemented implants justifies their use.
The results published in total prosthetic hip replacement surgery show higher medium-term survival rates when cementless implants are used. In his article, Feh- ring [26] checks implant survival in non-septic replacement surgery. Out of a total of 283 cases using cemented implants, 92 needed a second revision within 7 years whereas in another 468 cases of revision for aseptic weakening those that used unce- mented implants noted a 1.3 % (6 of 468) re-revision rate with the same follow-up as the previous group.
The success of the cemented techniques lies in the micro-interdigitation of cement within the cancellous structure of the femur. In replacement surgery a good femoral fixation using cemented techniques is not possible. Poor bone quality with cortical deficiencies and endostic sclerosis make long-term stability and implant survival less likely with cemented techniques. For that reason uncemented distal fixation implants are used.
Other circumstances may be responsable for precarious cemented fixation. Surgi- cal debridement carried out in the first stage can create disruptions at level of proxi- mal femur, in form of extended trocanteric osteotomy, to withdraw the femoral implants or the cement used in its fixation, false tracts related to accidental perfora- tions or even intraoperative fractures. None of these situations favours a correct
cementation but are compatible with the use of cementless implants associated with reconstruction techniques with bone grafts. The use of cemented implants makes a biological repair impossible; the use of uncemented diaphyseal fixation implants [38, 42, 55] associated with transosseous approaches allows the spontaneous reconstruc- tion of the weakened proximal bone. The method proposed is useful in conditions of bad cementing techniques [15, 22]. On some occasions the loss of bone stock is so extensive that a correct spontaneous repair cannot be expected and in these cases the two-stage revision using cementless implants allows us to use bone grafts to restore precarious bone stock in a biological way. Obviously a correct joint reconstruction that includes the use of bone grafts can only be considered when the septic process has been eradicated [108]. The advantages of cementless revision for infection are that they have the potential long-term fixation in a revision situation. Authors, such as Fehring [26], among others, arrive at the same conclusion.
None of our 23 patients showed signs of prosthetic dysfunction, with a follow up of 74.5 months. It is a useful method which avoids cementing in those cases where that would be precarious for the coexistence of fractures, false tracts, windows or osteoto- mies created during the debridement stage.
Cement with antibiotics is not essential for the treatment of infection associated with arthroplasties using this technique. Our eradication rate infection of 95.7 % (22 of 23 cases) certainly is superior in comparison with other series using antibiotic- impregnated cement. The advantages of cementless revision for infection are that they have the potential long-term fixation in a revision situation, and they lack the inhibitory effect on polymorphonuclear leukocytes arising from the presence of polymethylmetacrylate, which may have a deleterious effect on the immune system [74, 75]. Another effect negative originated by antibiotic-cement, it is derived from the potential risk of appearance of antibiotic-resistant bacteria by mutation. Some weeks after the use of the antibiotic-cement, the antibiotic liberation from the cement takes place to sub-therapeutic doses [45, 98].
Finally, eliminating the bone-cement interface allowed for healing with a simple antibiotic treatment retaining the implant. If the infection relapses, the elimination of the bone-cement interface allows healing with a simple antibiotic treatment, retain- ing the implant. In this series, the only case relapsed, we believe was due to the close relationship of the implant with the endostic vascular bed, a single prosthesis-bone interface where the humoral and cellular immune systems of the patient could act. It is possible that had there been a bone-cement interface, the result would not have been the same and the infection would have been spread by this interface due to a del- eterious effect on the immune system caused by the polymethylmetacrylate and the avascular character of the prosthesis-cement interface. Elimination of one of the interfaces, the cement–prosthesis, which could never receive an antibiotic treatment, uncemented components and distal support, intimate contact between the circula- tory system and the implant lets antibiotics reach the implant surface in the event of persistent infection.
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