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ORIGINAL ARTICLE
Year : 2015  |  Volume : 15  |  Issue : 3  |  Page : 249-253

Study of results of total hip replacement with indigenous ceramic components in combination


1 Department of Orthopedics, Burdwan Medical College and Hospital, Burdwan, West Bengal, India
2 Department of Physiology, Burdwan Medical College and Hospital, Burdwan, West Bengal, India
3 Department of Pathology, Burdwan Medical College and Hospital, Burdwan, West Bengal, India

Date of Web Publication2-Sep-2015

Correspondence Address:
Arunima Chaudhuri
Department of Physiology, Burdwan Medical College and Hospital, Krishnasayar South, Borehat, Burdwan - 713 102, West Bengal
India
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DOI: 10.4103/1319-6308.164296

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  Abstract 

Background: Total hip replacement (THR) arthroplasty at present it is the most commonly performed adult re-constructive hip procedure. Aims: To assess the clinical and functional outcome of the cementless ceramic THR. Materials and Methods: This pilot study was conducted in a tertiary care hospital of eastern India after taking institutional clearance and informed consent of the subjects. THR components were made from aluminum oxide from Central Glass and Ceramic Research Institute, Kolkata. During each visit, medical history was taken and physical examination was done. The deformity and range of motion (ROM) were measured with a goniometer. The clinical and functional outcomes were evaluated by modified Harris hip score. Results: 16 (80%) THR were on left and 4 (20%) were on left and age ranging from 34 to 66 years with a mean age of 52.2 years at the time of surgery. 14 (70%) were males and 6 (30%) females. At 2 years follow-up, the mean modified Harris hip score was 89.·With regards to the different parameters in the scoring system that is, pain, gait, functional activity, and ROM, there was significant improvement as per history. The results showed a significant improvement, wherein 33.33% had an excellent score and 50% showed good, and 16.7% had fair results. No patient had a poor score. Conclusion: Our study suggests that the current generation implants without cement can provide satisfactory clinical and radiographic outcomes after an intermediate duration of follow-up. Though the study was not free of complications, the overall functional and clinical outcome showed good results.

  Abstract in Arabic 

نتائج عمليات استبدال مفصل الورك بمكونات السيراميك:
خلفية: تعد عملية استبدال مفصل الورك بالكامل في الوقت الحاضر الأكثر شيوعاً في إعادة البناء الداخلي للورك عند الكبار.
الأهداف: هدفت الدراسة إلى التقييم السريري والوظيفي لنتائج عملية استبدال مفصل الورك بمكونات السيراميك الأصلسة ( غير الأسمنتية) .
المواد والطرق: أجريت هذه الدراسة في مستشفى الرعاية الشمالية في شرقي الهند بعد أخذ الموافقة الرسمية وموافقة المرضى. قدمّت المكونات لمواد استبدال مفصل الورك من أكسيد الألمونيوم من المعهد المركزي لأبحاث السيراميك الزجاج في مدينة كلكتا بالهند، وتم أخذ التاريخ المرضي والفحص البدني وتم قياس مدى الحركة مع مقياس الزوايا وتم تقييم النتائج السريرية والوظيفية للورك من خلال مقياس هاريس المعدل.
النتائج : كانت عملية والتى اجريت على 16 من المرضى (%80)في الجانب الأيسر و4على من المرضى (%20) كانت عملياتهم من الجانب الأيمن وتراوحت أعمارهم بين 34 - 66 عاما بمتوسط عمرى 52.2 عاما. وكان 14 من المرضى (%70) من الذكور و6 (%30) من الأناث وبعد متابعة المرضى على مدى عامين كانت نتيجة متوسط معيار هاريس المعدل (%89 ) وفيما يتعلق بالالم والمشى والنشاط الوظيفي أظهرت النتائج تحسنناً كبيراً حيث كان (%33.33) على درجة ممتازة و%50 نتائجهم جيدة و %16.70 نتائجهم مرضية.
الخلاصة: خلصت الدراسة إلى أن عمليات استبدال مفصل الورك بمكونات السيراميك الأصلية توفر نتائج سريرية وإشعاعية مرضية مع المتابعة الوسطية. ورغم أن الطريقة لا تخلو من المضاعفات الأ أن النتائج النهائية أظهرت مردوداً جيداً.

Keywords: Cementless ceramic implant, outcome, total hip replacement arthroplasty


How to cite this article:
Naskar D, Ghosh S, Chaudhuri A, Datta S, Chatterjee B, De C. Study of results of total hip replacement with indigenous ceramic components in combination. Saudi J Sports Med 2015;15:249-53

How to cite this URL:
Naskar D, Ghosh S, Chaudhuri A, Datta S, Chatterjee B, De C. Study of results of total hip replacement with indigenous ceramic components in combination. Saudi J Sports Med [serial online] 2015 [cited 2019 Nov 20];15:249-53. Available from: http://www.sjosm.org/text.asp?2015/15/3/249/164296


  Introduction Top


Total hip replacement (THR) arthroplasty at present it is the most commonly performed adult re-constructive hip procedure. [1],[2],[3],[4],[5],[6] The success of THR arthroplasty depends on its ability to relieve the pain associated with hip joint pathology while maintaining the mobility and stability of the hip joint.

The incidences of chronic disabling conditions of the hip such as osteoarthritis, inflammatory arthritis, and osteonecrosis are on the rise. To warrant doing THR, pain must be refractory to conservative measures such as oral nonsteroidal anti-inflammatory medication, weight reduction, activity restriction, and the use of supports such as a cane. [4],[5],[6],[7],[8],[9]

With contemporary prostheses and modern cementing techniques, the rate of femoral loosening appears to be substantially reduced. [1],[2],[3],[4],[5],[6] Regardless of the cementing technique, mechanical loosening occurs more commonly in young, heavy, active men and with certain prosthetic designs. Noncemented total hip arthroplasty (THA) was developed in response to evidence that cement debris plays an important role in promoting bone lysis and loosening. Prosthetic devices have been developed that achieve fixation without cement, either by "press-fit" or by biologic in growth. With the press-fit technique, stabilization is achieved by interference fit of the implant into the femur. With biologic in growth, fixation occurs by bone ingrowth into a porous surface. Noncemented devices are most frequently used in young patients with high physical demands, where a revision surgical procedure in the future will be more likely. Preliminary data suggest that noncemented total hip arthroplasties have a relatively low revision rate and excellent prosthetic durability for as long as 15 years. Compared with cemented hip arthroplasties, however, patients have a higher incidence of low-grade temporary thigh pain. Although short-term results appear to be less satisfactory compared with cemented hip arthroplasty, after 5-20 years, the results in the two procedures are similar. Early complications of hip arthroplasty include fracture, nerve injury, dislocation, deep vein thrombosis, and pulmonary embolism. Late complications include infection, heterotrophic ossification and loosening.

Aseptic femoral and acetabular loosening which is a potential cause of pain and loss of function have emerged as the most serious complications of THR and the most common indication for revision. [6],[7],[9],[10] Periprosthetic fractures of the femur can be a difficult problem to manage. Several factors contributing to these adverse effects, which may eventually result in failure of the THA, include the selection of the patients and the materials and design of the implant. [6],[7],[9],[10],[11] Many designs have been studied in an attempt to minimize these adverse effects and thus improve outcome. THR relieves the pain and functional disability experienced by patients with moderate to severe arthritis of the hip, improving their quality of life. [10] It is a highly cost-effective procedure. [6] The anatomically designed prosthesis can provide good results, with a low prevalence of pain in the thigh and loosening of the component, in younger active patients. Evaluation of long-term outcomes of an operative procedure is important to determine the durability of the procedures like THR. Patient-derived outcome scales have become increasingly important to surgeons and clinical researchers for measuring improvement in function after surgery. It provides a means for comparison of the results of different clinical interventions which may lead to changes in operative technique and implant design over time. The Harris hip score is the most widely used scoring system for evaluating hip arthroplasty. [6],[7],[9],[10],[11]

This study was undertaken to assess the clinical and functional outcome of the cementless ceramic THR. Ceramic implants for THA are popular worldwide nowadays, but indigenous ceramic implants have got popularity for its cost-effectiveness, as its cost is much less as compared to imported ceramic implants and it also has better wear character.


  Materials and Methods Top


This pilot study was conducted in a tertiary care hospital of Eastern India in a time span of 5 years after taking institutional clearance and informed consent of the subjects.

Inclusion criteria

All unilateral THA patients in the age group of 25-65 years, who had undergone TAH in Burdwan Medical College, with components - ceramic-on-ceramic cementless prosthesis due to various indications (e.g., fracture neck of femur, arthritis of hip-both primary and secondary, avascular necrosis of femoral head, failed osteosynthesis) were included. THR components were made from aluminum oxide from Central Glass and Ceramic Research Institute (CGCRI), Kolkata which is favored because of minimum wear rate (1:50 than metal), it is chemically inert and if there is any debris it is bioinert. It is corrosion resistant.

Exclusion criteria

Subjects suffering from ankylosing spondylitis, rheumatoid arthritis, diabetes mellitus, neuromuscular, psychiatric illness, ipsilateral bony injuries, spinal disorders were excluded.

Indications of THA are shown in [Table 1].
Table 1: Indications of THA

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Twenty patients were available for the follow-up with their previous operative records, annual X-ray films and follow-up papers. All patients underwent a standard clinical and laboratory evaluation that included brief information about age, sex, address, clinical history, and routine investigation which were done preoperatively. X-ray of hip joint with anteroposterior (AP) view was done.

Follow-up

The patients were followed-up at, 3 months, 6 months, 1-year, and at yearly intervals.

Clinical assessment

During each visit, medical history was taken and physical examination was done. The deformity and range of motion (ROM) were measured with a goniometer. The clinical and functional outcomes were evaluated by modified Harris hip score.

Based on a total of 100 points possible, each question is awarded a certain number of points. Questions are further grouped into categories.

The first category is pain. No pain in the hip is awarded 44 points, slight pain 40 points, down to 0 points for disabling pain. The second category is function. If there is no limp, do not use a walking aid, and can walk more than six blocks, 33 points were awarded; less if the patient was to use a cane, or walk only two blocks, etc. The third category, functional activities, consists of questions about how the patient climb stairs, put on shoes, length of time you can sit in a chair, and if the patient can use public transportation. Finally, the physical exam results are tabulated, and based on the absence of deformity and ROM, up to 9 points were awarded. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result. Based on this reasoning, a point scale with a maximum of 100 points is used with the following maximum possible scores: Pain 44; function 47; ROM 5; absence of deformity 4; total 100.

Radiological assessment

A radiograph was taken at the end of the procedure and during follow-up visits. The standard radiograph was an AP view of the pelvis including both hips and sufficient length of the femur. The radiological assessment included positioning and alignment of the acetabular and femoral components and complications such as periprosthetic fractures, loosening, osteolysis, dislocation, subsidence squeaking, infection, and heterotrophic ossification. Cup inclination was determined on the AP pelvic radiograph with a horizontal reference line drawn through the base of both teardrops. This radiograph was compared with the one made at the time of the last follow-up evaluation to determine fixation, total wear, the annual wear rate, and the presence, extent, and location of osteolysis. Cups without radiolucent lines or migration on the radiographs that were made at the time of the last follow-up were considered to be well-fixed. Cups with a circumferential radiolucent line of <1 mm in width and without migration were considered to have a stable fibrous union. Cups with progressive radiolucent lines and those exhibiting migration were considered to be loose. The prevalence, location, and extent of osteolytic lesions, progressive radiolucent lines, and calcar resorption were determined on AP radiographs made at the time of the last follow-up. Radiographic osteolysis was defined as so-called punched-out areas devoid of trabecular bone, usually with a sclerotic border. Periacetabular osteolytic lesions were assessed according to the zones described by DeLee and Charnley, and the femoral osteolytic lesions were assessed according to the zones described by Gruen. Calcar resorption (defined as rounding of the calcar with a convex shape and loss of calcar-collar contact) was differentiated from calcar osteolysis (defined as a punched-out, expansive area with a concave shape).


  Results Top


Totally, 16 (80%) THR were on left, and 4 (20%) were on left and age ranging from 34 to 66 years with a mean age of 52.2 years at the time of surgery. 14 (70%) were males and 6 (30%) females. The prosthesis used was made of ceramic from CGCRI, Kolkata.

At 2 years follow-up, the total mean score was 89. With regards to the different parameters in the scoring system that is, pain, gait, functional activity, and ROM, there was a significant improvement as per history. The results showed a significant improvement, wherein 33.33% had an excellent score and 50% showed good, and 16.7% had fair results. No patient had a poor score. 8 (40%) patients had limb length comparable to unaffected side. 8 patients had shortening of <1 cm, and 2 (25%) of them had an excellent outcome and 4 (50%) had fair and 2 (25%) had good results. In the age group of patients <40 years (10% of the study group), the patient had good postoperative outcome scores in his 1-year follow-up. In the 40-49 years age group 50% had excellent, and 25% had good and fair results each. In the patients above 50 years (30% of the study group), 33.3% had, good, fair and poor outcome scores each. Though the outcome scores were good and fair in 50% of >60 years (20% of the study group) group each noted.

Totally, 12 (60%) patients had acetabular angle within expected limit, 6 (30%) had low and 2 (10%) had a high acetabular angle. Mean acetabular angle was 43.6°. 3 (30%) patients with low angle had good, fair, and poor outcome scores respectively; 2 (10%) in high inclination had fair outcome score, others among the patients (60% of the study group) with normal inclination 4 (33.3%) had excellent, 6 (50%) had good, 2 (16.7%) had fair score.

In 10% of the patients, the femoral stem was in varus position and in 70% it was placed centrally, 20% in slight valgus orientation, 10% which was placed in varus had excellent outcome score, 4 patients with valgus oriented stem had good outcome score.

The most common complication was osteolysis (30%), head fractures (20%), squeaking (20%), and stress-shielding (10%). 50% did not have any complications. 20% head fractures patients had good outcome score each. 50% of the patients with no complications and showed excellent scores in 40% cases, good in 40% and 20% showed a fair outcome. 10% with varus positioning of the stem had anterior thigh pain. 10% of the patient with osteolysis experienced pain in the groin region with short distance walking with a poor score as well. 10% patient had squeaking but had good outcome score without any other complications.


  Discussion Top


Total hip arthroplasty is a well-documented surgical procedure. [5],[6],[7],[8],[9] It relieves pain and functional disability experienced by patients with moderate to severe arthritis of the hip, improving their quality of life. [6],[7],[8],[9],[10] Ceramic components are now accepted worldwide for their excellent biocompatibility and better wear character. We followed-up the patients undergone THA with indigenous cementless ceramic components. The prosthesis used was made of ceramic from CGCRI, Kolkata. Our study suggests that the current generation implants without cement can provide satisfactory clinical and radiographic outcomes after an intermediate duration of follow-up. Though the study was not free of complications, the overall functional and clinical outcome showed good results.

A study by Isaac et al. in 2009 [8] reported on ceramic-on-metal (CoM) bearings in THR. Whole blood metal ion levels were measured. The median increase in chromium and cobalt at 12 months was 0.08 μg/1 and 0.22 μg/1, respectively, in CoM bearings. Comparable values for metal-on-metal (MoM) were 0.48 μg/1 and 0.32 μg/1. The chromium levels were significantly lower in CoM than in MoM bearings (P = 0.02). Examination of two explanted ceramic heads revealed areas of thin metal transfer. CoM bearings (one explanted head and acetabular component, one explanted head and new acetabular component, and three new heads and acetabular components) were tested in a hip joint simulator.

Symptomatic cobalt toxicity from a failed THR is a rare but devastating complication. Potential clinical findings include fatigue, weakness, hypothyroidism, cardiomyopathy, polycythemia, visual and hearing impairment, cognitive dysfunction, and neuropathy. Zywiel et al. [9] reported a case of an otherwise healthy 46-year-old patient, who developed progressively worsening symptoms of cobalt toxicity beginning approximately 6 months following synovectomy and revision of a fractured ceramic-on-ceramic THR to a metal-on-polyethylene bearing. The whole blood cobalt levels peaked at 6521 μg/l. The patient died from cobalt-induced cardiomyopathy.

Fracture of a ceramic component in THR is a rare but potentially catastrophic complication. Whittingham-Jones et al. [10] described such a case, which illustrates how inadequate initial management will lead to further morbidity and require additional surgery. Ceramic component should be revised to another ceramic-on-ceramic articulation to minimize the risk of further catastrophic wear.

Due to its advantages, ceramic-on-ceramic bearings have been widely used in young patients for almost 30 years. Even though this material has had a lot of improvements, the risk of fracture is one of the concerns. Reátegui et al. [6] reported a case of a fracture in a sandwich type acetabular liner and the ceramic head in a patient involving ankylosing spondylitis. It occurred 3 years after the operation and with no history of direct trauma.

Currently, available ceramic materials are superior to those used originally in THA, which should translate into a much lower complication rate than what has been reported previously. In spite of this, a number of concerns remain. The ceramic-on-ceramic articulation is not immune to wear and surface damage. Conditions associated with ceramic wear include vertical cup position, femoral neck impingement, and femoral head separation. Although ceramics shows great promise as a lower wear articulation, manufacturing and design modifications and improvements will continue in an attempt to address the substantial concerns that persist. [7]

Stafford et al. [11] retrospectively analyzed 250 ceramic-on-ceramic hip replacements in 224 patients which had been implanted between April 2000 and December 2007. The mean age of the patients at operation was 44 years (14-83) and all the operations were performed using the same surgical technique at a single center. At a mean follow-up of 59 months (24-94), the mean Oxford hip score was 40.89 (11-48). There were six revisions, three of which were for impingement-related complications. No patient reported squeaking, but six described grinding or clicking, which was usually associated with deep flexion. No radiological evidence of osteolysis or migration of the components was observed in any hip. The early to mid-term results of contemporary ceramic-on-ceramic hip replacement show promising results with few concerns in terms of noise and squeaking. Positioning of the acetabular component remains critical in regard to the reduction of other impingement-related complications.


  Conclusion Top


The outcome of THA without cement is determined by multiple factors, including the design of the component, the selection of the patients, and the operative technique. The results of the procedure must be evaluated in long-term studies. Our study suggests that the current generation implants without cement can provide satisfactory clinical and radiographic outcomes after an intermediate duration of follow-up. Though the study was not free of complications, the overall functional and clinical outcome showed good results.

 
  References Top

1.
Mai K, Hardwick ME, Walker RH, Copp SN, Ezzet KA, Colwell CW Jr. Early dislocation rate in ceramic-on-ceramic total hip arthroplasty. HSS J 2008;4:10-3.  Back to cited text no. 1
    
2.
Hamilton WG, McAuley JP, Dennis DA, Murphy JA, Blumenfeld TJ, Politi J. THA with delta ceramic on ceramic: Results of a multicenter investigational device exemption trial. Clin Orthop Relat Res 2010;468:358-66.  Back to cited text no. 2
    
3.
Mai K, Verioti C, Ezzet KA, Copp SN, Walker RH, Colwell CW Jr. Incidence of 'squeaking' after ceramic-on-ceramic total hip arthroplasty. Clin Orthop Relat Res 2010;468:413-7.  Back to cited text no. 3
    
4.
Murphy SB, Bierbaum B. Eberle RW. American experience with alumina ceramic-ceramic bearings in total hip arthroplasty. In: Zippel H and Dietrich M editors. Bioceramics in Joint Arthroplasty. Steinkopff Darmstadt Publishers. 2003. p. 157-62.  Back to cited text no. 4
    
5.
Colwell CW Jr, Hozack WJ, Mesko JW, D'Antonio JA, Bierbaum BE, Capello WN, et al. Ceramic-on-ceramic total hip arthroplasty early dislocation rate. Clin Orthop Relat Res 2007;465:155-8.  Back to cited text no. 5
    
6.
Barrack RL, Burak C, Skinner HB. Concerns about ceramics in THA. Clin Orthop Relat Res 2004;429:73-9.  Back to cited text no. 6
    
7.
Reátegui D, García S, Bori G, Gallart X. Fracture of ceramic liner and head in a total hip arthroplasty with a sandwich type cup. Case Rep Orthop 2013;2013:291691.  Back to cited text no. 7
    
8.
Isaac GH, Brockett C, Breckon A, van der Jagt D, Williams S, Hardaker C, et al. Ceramic-on-metal bearings in total hip replacement: Whole blood metal ion levels and analysis of retrieved components. J Bone Joint Surg Br 2009;91:1134-41.  Back to cited text no. 8
    
9.
Zywiel MG, Brandt JM, Overgaard CB, Cheung AC, Turgeon TR, Syed KA. Fatal cardiomyopathy after revision total hip replacement for fracture of a ceramic liner. Bone Joint J 2013;95-B: 31-7.  Back to cited text no. 9
    
10.
Whittingham-Jones P, Mann B, Coward P, Hart AJ, Skinner JA. Fracture of a ceramic component in total hip replacement. J Bone Joint Surg Br 2012;94:570-3.  Back to cited text no. 10
    
11.
Stafford GH, Islam SU, Witt JD. Early to mid-term results of ceramic-on-ceramic total hip replacement: Analysis of bearing-surface-related complications. J Bone Joint Surg Br 2011;93:1017-20.  Back to cited text no. 11
    



 
 
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