Preformed Spacers Research Articles

Commercially manufactured spacers for the treatment of periprosthetic joint infection of the hip.

Periprosthetic joint infection remains acommon and serious complication after hip arthroplasty. To improve function and patient comfort after joint removal in two-stage revision, commercially manufactured spacers for the hip joint allow retention of the anatomical joint geometry thereby limiting soft tissue contraction and allow mobilization. Periprosthetic joint infection of the hip, septic arthritis with severe destruction of the hip cartilage and/or bone requiring arthroplasty. Allergies to polymethylmethacrylate (PMMA) or antibiotics, severe hip dysplasia with insufficient cranial support, incompliant patient, large osseous defect of the acetabulum, insufficient metaphyseal/diaphyseal support of the femoral bone, resistance of the microbiological pathogen to spacer-inert antibiotic medication, inability to perform primary wound closure requiring temporary open-wound therapy. Preoperative templating on radiograph; removal of joint prosthesis and thorough debridement with removal of all foreign material; trial spacer selection and insertion and trial reduction of the joint, fixing the spacer with PMMA to the proximal femur, final reduction, radiograph and stability test. Data were analyzed from patients treated between 2016 and 2021. In all, 20patients were treated with preformed spacers and 16with custom-made spacers. Pathogens were detected in 23of the 36cases (64%). Polymicrobial infections were present in 8of 36cases (22%). In patients who received preformed spacers, there were 6cases of spacer-related complications (30%). Of the 36patients (83%), 30were reimplanted with anew implant; 3patients died due to septic or other complications before reimplantation (8%). Average follow-up was 20.2months after reimplantation. There were no major differences between the two groups of spacers. Patient comfort was not measured.

Обоснование выбора спейсера на первом этапе лечения поздней глубокой перипротезной инфекции коленного сустава

Background Periprosthetic infection develops in 0.5 to 5.0 % of cases after knee replacement, which is a social and economic problem. The most common causes of periprosthetic infection are methicillin-resistant staphylococcus aureus (MRSA) (36 %), gram-negative bacteria, and microbial associations. The study was aimed at improving the results of the sanitizing stage of revision arthroplasty in patients with periprosthetic infection of the knee joint by a developed long-acting antimicrobial composition and improving the designs of articulating spacers of the knee joint. Materials and Methods The treatment results of 121 patients with knee joint periprosthetic infection were analyzed. Nine patients had an early periprosthetic infection and 112 had a late one. Patients in satisfactory condition with stable implant components who had early periprosthetic infection underwent surgical treatment of the purulent focuses, replacement of a polyethylene tibial insert, thorough surgical wound washing using pulse lavage, drainage, and VAC-therapy. Patients with late periprosthetic infection were divided into 3 groups on the basis of the spacer used. An articulating spacer based on the developed antimicrobial composition of prolonged action (RU 191236 patent) was used in 59 patients of the first group. Preformed spacers were implanted in 29 patients of the second group, and 18 patients of the third group got a block-shaped spacer. Results An antibacterial anti-adhesive non-toxic composition with a prolonged action based on bone cement with gentamicin and such antiseptics as poviargol, dioxydine, and high-molecular polyvinylpyrrolidone has been developed. All the patients underwent the sanitizing stage of revision arthroplasty, implant removal, and spacer installation. Periprosthetic infection recurrence developed in 3 patients of the first group, 9 patients of the second group and 7 patients of the third one. The average time from the sanitizing stage to the second final stage of revision was 3-6 (4.8 ± 1.9) months. Discussion According to scientific data, the impregnation of new antibiotics into bone cement with gentamicin does not improve the antimicrobial effect of a spacer, especially in case of antibiotic-resistant strains. Block-shaped and preformed spacers lead to infection recurrence and complications. Antiseptic impregnation with different mechanisms of action is able to affect antibiotic-resistant bacteria, and the polymer is able to prolong the effect. Conclusion The use of articulating spacers for the knee joint, which include an antimicrobial composition, allows preserving the function of the joint and reducing the number of infectious complications, which facilitates the final stage of revision arthroplasty.

Comparing the use of preformed vs hand-made antibiotic spacer cement in two stages revision of hip periprosthetic infection

BackgroundThe number of periprosthetic joint infections (PJI) is continuously increasing because of the increasing number of arthroprostheses performed every year. Two-stage revision, using antibiotic-loaded spacers, remains the gold standard for their treatment. The aim of our study is to compare the use of preformed vs hand-made spacers in hip arthroplasty infections evaluating infection eradication, bone loss and clinical/functional outcomes. MethodsFrom January 2010 to December 2017 we performed a prospective nonrandomized study. We pooled 50 patients affected by infected hip joint replacements, and divided them in 2 groups, one receiving commercially preformed spacers and the other receiving hand-made spacers. The study endpoint was set at 12 months. Intra-operative and peri-operative complications, Harris Hip Score (HHS), Short Form 12 Health Survey, intra-operative and radiological evaluation of bone loss were collected. Data were analyzed using descriptive statistics, T-test and Fisher Exact test. ResultsWe found a statistically significant differences (p < 0.05) between the two groups in favour of the VancogenX group for the following variables: surgical time, first and second stage intraoperative complication rates, infection eradication. Moreover, the preformed-spacers group had better results in the preservation of bone stock, even though the difference was not statistically significant (p > 0.05). ConclusionOur results support the use of preformed antibiotic spacers, even though more studies are needed.

Polyethylene on Cement Spacers: An Economic Approach to an Effective Infection Eradication in a Two-Stage Knee Revision Articulating Spacers.

Although two-stage revision surgery is generally considered as the gold standard treatment for periprosthetic joint infection (PJI) after total knee arthroplasty, the procedure is limited by the costs of commercially preformed spacers used for treatment. In this work, we aim to report a modified approach by which the cost of the spacer could be significantly reduced without compromising eradication of infection. Between 2010 and 2016, we performed a total of 11 two-stage revision arthroplasties using a surgically handmade spacer with a new polyethylene insert. Patients were aged 59 to 80 years old (mean 69.9 years), with a range of motion (ROM) between 20° and 65° on the affected knee (mean 46.4°) before the first-stage revision surgery. During the perioperative and postoperative period, functional and clinical evaluation of the patients were performed, including the determination of their articular ROM, Knee Society Knee Scores (KSKS), and Knee Society Function Scores (KSFS). All patients were followed up for an average of 2 years, ranging from 1 to 4 years. After the second-stage revision surgery, the mean ROM was increased by 46.8° (46.4°-93.2°) after the second-stage revision. KSKS and KSFS scores were recorded to increase by an average of 44.5° (range 40.4°-84.9°) and 46.9° (range 38.5°-85.4°), respectively. All 11 patients underwent a successful two-stage revision surgery, and no evidence of postsurgical infection was found during patient follow-up examination. Our results show that this personalized handmade antibiotic-loaded articulating spacer is cost-effective and efficacious.

Augmentation with antibiotic-impregnated spacers in sepsis revision surgery

The development of antibiotic-impregnated polymethyl methacrylate (PMMA) spacers is based on clinical experience and the use of antibiotic-loaded PMMA beads in septic bone surgery as well as antibiotic-loaded bone cement in arthroplasty beginning in the 1970s. In the meantime hand-formed and prefabricated spacers are implanted in cases of sepsis to achieve high local antibiotic concentrations and bactericidal effects to eradicate the infection. Preformed spacers with gentamicin are commercially available and furthermore, clindamycin-loaded PMMA bone cement can also be used. In principle, all thermostable antibiotics can be mixed with PMMA cement. Spacers permit bridging of bone defects originating from trauma or septic bone segment resection. After joint resection spacers allow a certain degree of articulation and inhibit shortening of the extremity which has a positive effect on the soft tissue covering and its perfusion. The functional outcome after secondary arthroplasty is better if a spacer has been implanted compared to long-term immobilization without spacers. Nevertheless, spacers can also cause serious complications, such as dislocations and fractures. Antibiotic-loaded spacers have therefore widened the therapeutic options in sepsis surgery.

Are Preformed Articulating Spacers Superior To Surgeon-Made Articulating Spacers in the Treatment Of PJI in THA? A Literature Review.

Background and Purpose:Antibiotic-loaded cement spacers are typically manufactured by surgeons in the operating room. However, if the infecting organism is known preoperatively, the cement spacer can be fabricated (Spacer-G® or the InterSpace® Hip) in advance. It is unclear if preformed hip spacers are superior to surgeon-made hip spacers in the treatment of periprosthetic joint infection following primary THA.Methods:A literature review of the peer-reviewed literature indexed by MEDLINE and Embase was performed to identify studies reporting the outcomes of preformed and surgeon-made hip spacers in the treatment of infection following primary total hip arthroplasty (THA). A total of 43 articles met the inclusion criteria and were included in the analysis to compare the reinfection rate, Harris Hip Score (HHS) and spacer complication rates between surgeon-made and preformed hip spacers.Results and Interpretation:The analyzed studies included a total number of 1631 infected THA cases (n=1027 surgeonmade; n=604 preformed spacers). We found similar reinfection rates (6.0% surgeon-made, and 5.5% preformed spacers) and similar mean HHS at latest follow-up after reimplantation (HHS=84.3 surgeon-made, and HHS=81.8 preformed spacers) between both groups. However, patients treated with a surgeon-made articulating spacer had a higher spacer fracture rate compared to preformed articulating spacer. The use of preformed articulating spacers in the treatment of infected THA is not superior to surgeon-made articulating spacers regarding infection control and functional outcomes. However, the use of surgeon-made antibiotic spacers increased the risk of spacer fracture.

Custom Made (PMMA) Intervertebral Spacer in TLIF Preliminary Results of a Prospective Randomized Trial

Introduction The use of bone cement in orthopedic surgery has been quite current for many years. In spine surgery, it has been used first for replacing defects after corpectomy. Then, vertebroplasty and kyphoplasty got used worldwide. Sporadically, some surgeons used cement to refill the intervertebral space after discectomy, combined with dorsal stabilization and fusion. Most recently in our institution, we started to perform routinely percutaneous cement discoplasty, for elderly patients. We also use PMMA as a spacer in TLIF. In a previous retrospective analysis, we reviewed results with this kind of surgeries. The aim of this study was to validate the use of custom-made PMMA spacer in TLIF with a high level of evidence in a randomized, prospective study. Patients and Methods In our study, we planned to collect 100 consecutive patients to whom we perform one level TLIF in the lumbar spine. The patients are randomized in three groups by the GraphPad QuickCalcs software. Group A is standard TLIF with PEEK spacer positioned in the anterior part of the intervertebral space. Group B is standard TLIF with PMMA spacer placed in the anterior part of the intervertebral space. Group C is standard TLIF with PMMA spacer positioned in the posterior part of the intervertebral space. Patients between the age of 18 and 65 years were included. Patients with a high-grade spondylolisthesis, metabolic bone disease, spinal infection, cancer, and severe scoliosis (Cobb over 30 degrees) were excluded. We evaluate the clinical results with standard questioners. Radiological evaluation focuses on bony fusion, loosening of any instrument implanted (PMMA spacer or screws), osteolysis around the cement, subsidence, changes in segmental, and overall lordosis according to the position of the spacer. Results Until today, 40 patients have a minimum of 1-year follow-up. We present these early results. On CT scan 6 months after surgery, we could observe completed fusion in 78.5% of the operated segments. The fusion rate was higher in the PMMA spacer groups (B + C), but the difference is not significant. We found six subsidence (15%), from four was in the PEEK spacer group (A) meaning, that the subsidence rate was significantly higher in this group. We found radiolucent zone around the implant (loosening) in only two cases (5%), one in the group A and one in group B. The overall clinical result was very good in 61%, good in 28%, and poor in 11% of the cases without significant difference between the groups. Conclusion With this preliminary results, we can estimate that the use of custom-made PMMA spacer in TLIF even in younger population provides good results noninferior to preformed PEEK spacer, and it even has some following advantages on preformed cages: (1) It fits better to irregularity of the end plates than preformed spacers, which can correlate with the difference in subsidence rate. (2) It requires smaller annular window to implant.

Preformed Antibiotic-Loaded Cement Spacers for Two-Stage Revision of Infected Total Hip Arthroplasty. Long-Term Results

Two-stage revision is the most widely accepted and performed intervention for chronically infected hip prosthesis and different interim spacers have been proposed. In recent years, antibiotic-loaded preformed spacers have become available on the market. The aim of this retrospective study was to assess the long-term results of two-stage revision with preformed spacers and uncemented hip prosthesis for the treatment of septic hip prosthesis. From 2000 to 2010, 183 consecutive patients underwent two-stage revision of septic hip prosthesis, with a same protocol, including preformed antibiotic-loaded cement spacer and a cementless modular hip revision prosthesis and four to six weeks antibiotic administration. Clinical and radiologic assessment at a minimum follow-up of two years was performed. At a minimum two years follow-up, 10 patients (5.4%) had had an infection recurrence, four (2.2%) an aseptic loosening and four more required partial revision of the modular components of the prosthesis, because of hip instability/dislocation; 21 patients died or were lost to follow-up. Considering all the reasons for revision, survivorship at eleven years was 93.9%. Harris Hip Score improved from 29.1 ± 14.6 pre-operatively to 41.1 ± 15.9 after spacer implant and 81.7 ± 17.6 after hip revision. The main complications after spacer implant included: spacer dislocation (16.4%), intra-operative femoral fractures (2.7%), and thromboembolism (2.1%). Complications after hip revision were: instability/dislocation (4,3%), intra-operative femoral fractures (1.6%), and thromboembolism (3.3%). Two-stage revision of septic hip prosthesis with preformed antibiotic-loaded spacers and cementless hip prosthesis provides satisfactory long-term results, with reduced complications.

Two-stage revision surgery with preformed spacers and cementless implants for septic hip arthritis: a prospective, non-randomized cohort study

BackgroundOutcome data on two-stage revision surgery for deep infection after septic hip arthritis are limited and inconsistent. This study presents the medium-term results of a new, standardized two-stage arthroplasty with preformed hip spacers and cementless implants in a consecutive series of adult patients with septic arthritis of the hip treated according to a same protocol.MethodsNineteen patients (20 hips) were enrolled in this prospective, non-randomized cohort study between 2000 and 2008. The first stage comprised femoral head resection, debridement, and insertion of a preformed, commercially available, antibiotic-loaded cement hip spacer. After eradication of infection, a cementless total hip arthroplasty was implanted in the second stage. Patients were assessed for infection recurrence, pain (visual analog scale [VAS]) and hip joint function (Harris Hip score).ResultsThe mean time between first diagnosis of infection and revision surgery was 5.8 ± 9.0 months; the average duration of follow up was 56.6 (range, 24 - 104) months; all 20 hips were successfully converted to prosthesis an average 22 ± 5.1 weeks after spacer implantation. Reinfection after total hip joint replacement occurred in 1 patient. The mean VAS pain score improved from 48 (range, 35 - 84) pre-operatively to 18 (range, 0 - 38) prior to spacer removal and to 8 (range, 0 - 15) at the last follow-up assessment after prosthesis implantation. The average Harris Hip score improved from 27.5 before surgery to 61.8 between the two stages to 92.3 at the final follow-up assessment.ConclusionsSatisfactory outcomes can be obtained with two-stage revision hip arthroplasty using preformed spacers and cementless implants for prosthetic hip joint infections of various etiologies.

Long-Stem versus Short-Stem Preformed Antibiotic-Loaded Cement Spacers for Two-Stage Revision of Infected Total Hip Arthroplasty

Two-stage revision is the most widely accepted and performed intervention for chronically infected hip prostheses. In recent years short and long stem antibiotic-loaded preformed spacers have become available on the market. The aim of this prospective, comparative study was to assess the safety and efficacy of long stem versus short stem preformed spacers. From year 2000 to 2007 102 consecutive patients underwent two-stage revision of septic hip replacement with a preformed antibiotic-loaded cement spacer and a cementless modular hip revision prosthesis. Patients were divided in two groups: Group L (long stem spacer) (N=60) and Group S (short stem) (N=42) and compared. No systemic toxicity due to local antibiotic release and no spacer breakage were observed in either group. At spacer removal, no statistically significant difference was observed in infection recurrence. After revision, at a mean 4 years follow-up, 2 patients in Group L and 2 in Group S showed infection recurrence. The Harris Hip Score improved in both groups, compared to post spacer implant values: 79.6 + or - 15.4 versus 38.4 + or - 14.5 in Group L (p < 0.0001) and 82.3 + or - 14.4 versus 44.8 + or - 16.6 in Group S (p < 0.0001); the difference between groups was not statistically significant. Short and long stem spacers provide comparable low infection recurrence rate and clinical outcome, with negligible risk of breakage and toxicity.

Tecnica chirurgica di revisione in due tempi: protesi di anca

118 patients with infected total hip arthroplasty were treated with two-stage revision, using a preformed antibiotic-loaded cement spacer and a cementless modular hip revision prosthesis. At a minimum follow-up of 2 years (maximum 9 years), 106 patients did not show any clinical or laboratory sign of infection recurrence, 4 (3.6%) had infection recurrence while 8 are lost to follow-up. Survival after 9 years is 91.2% and 87.7% considering as end points infection recurrence or all reasons for revision, respectively. Preformed antibiotic spacers and non-cemented hip revision prostheses appear an effective solution for infected total hip prosthesis.