Similar migration for medial congruent and cruciate-retaining tibial components in an anatomic TKA system: a randomized controlled trial of 60 patients followed with RSA for 2 years.

Background and purpose - There is an ongoing debate regarding the appropriate level of constraint in primary TKA. To provide increased stability and better kinematics, more resembling a natural knee, a medial congruent (MC) tibial insert has been introduced. To investigate potential impact on implant migration, we evaluated the cemented Persona TKA, randomizing between MC and cruciate-retaining (CR) tibial designs. Patients and methods - 60 patients with primary osteoarthritis were randomized to either the CR or MC tibial component. Radiostereometric analysis (RSA) examinations, evaluating translational and rotational migration as well as maximal total point motion (MTPM), were performed on the first postoperative day, at 3 months, and 1 and 2 years after surgery. Preoperative, and 1- and 2-year patientreported outcome measures (PROMs) data (KOOS and FJS) were collected. Results - The mean tibial MTPM at 3 months were 0.48 mm (95% CI 0.37-0.58) and 0.56 mm (0.45-0.67) for the CR and MC respectively. 2 years postoperatively the respective values were 0.62 mm (0.50-0.73) and 0.73 mm (0.49-0.96). There was no statistically significant difference in migration between groups, for either the femoral or the tibial component, regarding x-, y-, and z-translations or rotations. Both CR and MC groups improved as expected in PROM scores pre- to postoperatively, but without a statistically significant difference between groups. There were no revisions or other serious adverse events related to surgery. Interpretation - The results are promising, indicating good fixation for both designs, and this is in line with other well-performing TKAs on the market. The increased medial congruity of the MC inlay does not seem to affect the migration or the PROMs up to 2 years.

Is a hollow centralizer necessary when using a polished, tapered, cemented femoral stem?

Background and purpose - A tapered, polished and collarless stem is normally equipped with a hollow centralizer to prevent the stem from becoming end-bearing in the cement as the stem subsides. In a randomized clinical trial, we evaluated such a stem (MS-30), which was initially introduced with a solid centralizer but was later recommended to be fitted with a hollow centralizer. We hypothesized that while the stem would sink more, it would become rotationally stable and have less retroversion with a hollow centralizer than with a solid centralizer. Patients and methods - We randomized 60 patients with primary hip arthritis to receive either a hollow centralizer or a solid centralizer with the stem. The effect was evaluated over a 10-year follow-up period with repeated RSA examinations, conventional radiographs, and clinical follow-ups using the WOMAC and SF-12 questionnaires. Results - At 10-year follow-up, the group with hollow centralizers had subsided more than the group with solid centralizers (1.99 mm (hollow) as opposed to 0.57 mm (solid); p < 0.001). However, rotation was similar at 10-year follow-up (mean retroversion 1.34° (hollow) and 1.30° (solid)). Both groups showed excellent 10-year results, with similar clinical outcome, and none of the stems were radiographically loose or had been revised. Interpretation - As expected, there was more subsidence in the group with hollow centralizers, and with similar magnitude to that reported in earlier RSA studies on conceptually similar prostheses. Interestingly, there was no difference in the rotational behavior of the prostheses. This stem type appears to have a design that, regardless of the type of centralizer and the possibility of subsidence, withstands the rotational forces it is subjected to very well. This study does not support the need for a hollow centralizer for these types of stems.

Local treatment of cancellous bone grafts with BMP-7 and zoledronate increases both the bone formation rate and bone density: a bone chamber study in rats.

BACKGROUND AND PURPOSE: The remodeling of morselized bone grafts in revision surgery can be enhanced by an anabolic substance such as a bone morphogenetic protein (BMP). On the other hand, BMPs boost catabolism and might cause a premature resorption, both of the graft and of the new-formed bone. Bisphosphonates inactivate osteoclasts and can be used to control the resorption. We studied a combination of both drugs as a local admix to a cancellous allograft. METHODS: Cancellous bone allografts were harvested and freeze-dried. Either saline, BMP-7, the bisphosphonate zoledronate, or a combination of BMP-7 and zoledronate were added in solution. The grafts were placed in bone conduction chambers and implanted in the proximal tibia of 34 rats. The grafts were harvested after 6 weeks and evaluated by histomorphometry. RESULTS: Bone volume/total volume (BV/TV) was 50% in the grafts treated with the combination of BMP-7 and zoledronate and 16% in the saline controls (p < 0.001). In the zoledronate group BV/TV was 56%, and in the BMP group it was 14%. The ingrowth distance of new bone into the graft was 3.5 mm for the combination of BMP-7 and zoledronate and 2.6 mm in the saline control (p = 0.002). The net amount of retained remodeled bone was more than 4 times higher when BMP-7 and zoledronate were combined than in the controls. INTERPRETATION: An anabolic drug like BMP-7 can be combined with an anti-catabolic bisphosphonate as local bone graft adjunct, and the combination increases the amount of remaining bone after remodeling is complete.

No effect of femoral canal jet-lavage on the stability of cementless stems in primary hip arthroplasty: a randomised RSA study with 6 years follow-up.

INTRODUCTION: In contrast to cemented hip prostheses, the effect of washing the bone bed with jet-lavage prior to insertion of cementless stem components in primary hip arthroplasty (THA) is unclear. Jet-lavage potentially decreases the risk of fat embolisation during rasping and stem insertion and might help in avoiding bacterial contamination. An earlier animal study has shown less debris and better-organised trabecular structure of new bone when jet-lavage was used. We hypothesised that the primary stability of cementless femoral stems implanted after jet-lavage of the femoral canal prior to stem insertion would improve with earlier stabilisation, as measured with Radiostereometry (RSA), compared with insertion without prior jet-lavage. METHODS: 40 patients with primary osteoarthritis operated on with a cementless titanium grit blasted stem are included in the study. The patients were randomised to either jet-lavage or control without any lavage of the femoral canal prior to insertion of the prosthesis. The stem migration pattern was measured with RSA at 0, 3, 12, 24 and 72 months. RESULTS: At 6 years, 19 patients remained for analysis in the jet-lavage and 18 in the control group. We found no difference in extent or pattern of migration as measured with RSA. Both groups seemed to have stabilised within 3 months after a slight subsidence and retroversion. No stem was revised or considered loose as measured with RSA. CONCLUSIONS: Washing the bone bed with jet-lavage prior to insertion of cementless stems does not affect the stability of cementless femoral components. No adverse effects were observed.

Locally administered bisphosphonate in hip stem revisions using the bone impaction grafting technique: a randomised, placebo-controlled study with DXA and five-year RSA follow-up.

BACKGROUND:: Bisphosphonates have previously been shown to increase the density of impacted graft bone. In the present study we hypothesise that bisphosphonates also reduce early stem subsidence. We examined the effect of locally applied bisphosphonate to allografts on prosthetic micromotion and bone density in femoral stem revision with impaction grafting. METHODS:: 37 patients were randomised to either clodronate or saline as local adjunct to the morsellised allograft bone. 24 patients were finally analysed per protocol and evaluated by dual-energy x-ray absorptiometry (DXA) during the first year and with radiostereometric analysis (RSA) for 5 years. RESULTS:: There were no significant differences neither in bone density, nor in migratory behaviour between the groups. The femoral stems had subsided 3.6 mm in both groups (p = 0.99) at 5 years and there was no difference as measured over time with mixed models analysis. The clinical outcome was good in both groups. CONCLUSION:: Clodronate as a local addendum to allograft bone in hip revision did not increase bone density or reduce micromotion of the implant.

Effect of femoral head size on polyethylene wear and synovitis after total hip arthroplasty: a sonographic and radiographic study of 39 patients.

BACKGROUND AND PURPOSE: The role of synovitis and high fluid pressure in the loosening process after total hip arthroplasty has gained increasing attention. We investigated the correlation between head size, polyethylene wear, and capsular distention. PATIENTS AND METHODS: We analyzed 39 unrevised, radiographically stable hips that had been operated with 28 or 32 mm femoral heads 10 years earlier because of osteoarthritis. We evaluated radiographic signs of loosening, linear and volumetric polyethylene wear, body mass index, activity level, and age. Sonographic examination was performed to measure capsular distance i.e. the distance between the prosthetic femoral neck and the anterior capsule. RESULTS: Linear wear was 0.09 mm/year and 0.18 mm/year in the 28 mm and 32 mm groups, respectively (p < 0.001). The volumetric wear was 51 mm(3)/year and 136 mm(3)/year (p < 0.001) and the capsular distance was 13 mm and 17 mm, respectively (p < 0.001). There was a correlation between linear wear (r = 0.54), volumetric wear (r = 0.62), and capsular distance (p < 0.001). INTERPRETATION: Wear was greater for the larger femoral head and was correlated to capsular distension.

Exeter total hip arthroplasty with matte or polished stems.

OBJECTIVE: To compare implant survival rates after total hip arthroplasty with Exeter matte or polished stems and to determine the relationship of synovitis/joint effusion to signs of implant loosening and stem type. MATERIAL AND METHODS: The first part of the study included retrospective revision rate analysis of 118 primary hip replacements performed during 1991-1995. Two different designs of Exeter stems were used: matte surface stems during 1991-1995 (matte surface group--47 cases), and polished stems during 1992-1995 (polished stem group--71 cases). During the second part of the study, 24 patients (11 in polished stem group and 13 in matte stem group) were prospectively examined with radiography and sonography. Sonography was performed in order to evaluate capsular distension, i.e. the distance between prosthetic femoral neck and anterior capsule. Capsular distension depends on synovitis and/or synovia in prosthetic hip. The relationship between capsular distension, stem type, and radiographic signs of loosening was assessed. RESULTS: For the first part of our study, total implant survival was 78% with matte stems and 61% with polished stems 13 years postoperatively (P=0.27). Stem survival was 82% for matte stems, and 88% for polished stems (P=0.54). In the second part of study, a significant relationship between increased capsular distension and cup loosening was determined (P=0.04). We did not find significant difference in capsular distension when compared matte and polished stems. CONCLUSION: Implant survival rates did not differ between the groups. The relationship between capsular distension and cup loosening was statistically significant.

Stable migration pattern of an ultra-short anatomical uncemented hip stem: a prospective study with 2 years radiostereometric analysis follow-up.

INTRODUCTION: Shorter, anatomically shaped and proximally loading stems have been developed to achieve better stress distribution and be more bone preserving. The purpose of this prospective study was to evaluate the migration pattern of the Proxima™ ultra-short uncemented stem using radiostereometric analysis (RSA), and to review the literature regarding the migration of short stemmed hip arthroplasty. METHODS: 25 patients (28 hips) with hip osteoarthritis received a Proxima stem during total hip arthroplasty (THA). To measure stem migration, repeated RSA examinations were done during a 2 year follow up period. The patients were evaluated with the hip specific (HOOS) and the generic health (EQ5D) scores up to 1 year, and clinically for 6 years postoperatively. RESULTS: Almost all migration occurred within the first 3 months, with mean subsidence of 0.22 mm and varus rotation of 1.04°, being the primary effect variables. After the third postoperative month and up to the 2 year RSA follow up no further significant migration occurred. The outcome scores showed substantial improvement after 1 year. No revisions were performed or indicated for any stem after a mean clinical follow up of 72.1 months. CONCLUSIONS: Like many other uncemented stems, the Proxima showed early migration up to 3 months hereafter osseointegration seems to have occurred. The achieved stability and clinical outcomes indicate favorable early results for this stem in younger patients who have good bone quality and average BMI. We found, however, the surgical technique to be slightly more demanding compared to conventional stems owing to the unique implant design that necessitates specific adjusted femoral cutting and broaching procedures.

A CT method for following patients with both prosthetic replacement and implanted tantalum beads: preliminary analysis with a pelvic model and in seven patients.

BACKGROUND: Radiostereometric analysis (RSA) is often used for evaluating implanted devices over time. Following patients who have had tantalum beads implanted as markers in conjunction with joint replacements is important for longitudinal evaluation of these patients and for those with similar implants. As doing traditional RSA imaging is exacting and limited to specialized centers, it is important to consider alternative techniques for this ongoing evaluation. This paper studies the use of computed tomography (CT) to evaluate over time tantalum beads which have been implanted as markers. METHODS: The project uses both a hip model implanted with tantalum beads, acquired in several orientations, at two different CT energy levels, and a cohort of seven patients. The model was evaluated twice by the same observer with a 1-week interval. All CT volumes were analyzed using a semi-automated 3D volume fusion (spatial registration) tool which provides landmark-based fusion of two volumes, registering a target volume with a reference volume using a rigid body 3D algorithm. The mean registration errors as well as the accuracy and repeatability of the method were evaluated. RESULTS: The mean registration error, maximum value of repeatability, and accuracy for the relative movement in the model were 0.16 mm, 0.02° and 0.1 mm, and 0.36° and 0.13 mm for 120 kVp and 0.21 mm, 0.04° and 0.01 mm, and 0.39° and 0.12 mm for 100 kVp. For the patients, the mean registration errors per patient ranged from 0.08 to 0.35 mm. These results are comparable to those in typical clinical RSA trials. This technique successfully evaluated two patients who would have been lost from the cohort if only RSA were used. CONCLUSIONS: The proposed technique can be used to evaluate patients with tantalum beads over time without the need for stereoradiographs. Further, the effective dose associated with CT is decreasing.

Intracapsular pressure and elasticity of the hip joint capsule in osteoarthritis.

We investigated intracapsular pressure and elasticity of the hip joint capsule in osteoarthritis. HOOS hip score, sonography of the hip joint, and radiographic assessment of osteoarthritis were performed in 31 patients before total hip arthroplasty. The intracapsular hydrostatic pressure was measured perioperatively, and 0.9% saline solution was then injected in the hip joint, 1 mL at a time, with continuous pressure recording up to 300 mm Hg. The mean radiographic grade of severity of osteoarthritis was 8 (SD, 2.4). The mean hydrostatic intracapsular pressure in 45 degrees of flexion was 2.2 mm Hg (SD, 10.0); in extension, 15.8 mm Hg (SD, 33.0); in inward rotation, 13.7 mm Hg (SD, 26.0); and in outward rotation, 12.1 mm Hg (SD, 24.3). Severe osteoarthritis was associated with lower intracapsular pressure and lower elasticity of the joint capsule.

Introduction of total hip arthroplasty in Lithuania: results from the first 10 years.

BACKGROUND: Hip replacement as a routine procedure was introduced in Lithuania in 1991. At Klaipeda Hospital, one of the 2 hospitals at which this was begun, the arthroplasties were followed prospectively from the start. This study concerns the 10-year results from a country with no previous experience of hip replacement. The results are compared with those from a hospital with considerable experience of total hip replacement. METHODS: We compared the revision rate for the first 658 primary ScanHip arthroplasties inserted at Klaipeda to that for the first 939 ScanHip primary arthroplasties inserted at Lund University Hospital, Sweden. Only patients with osteoarthritis were included, and the endpoint was revision for aseptic loosening with exchange of one or both components. RESULTS: We found that patients operated at Klaipeda Hospital had a significantly higher risk of revision (12%) than those operated in Lund (6%). INTERPRETATION: Although we could not identify any specific reason for the Swedish results being better than the Lithuanian results, it is probable that previous surgical inexperience of hip replacement in Lithuania played a role. We believe that the findings will stimulate surgeons in Lithuania to analyze their failures and improve the results.

Dynamics of hip joint effusion after posterior soft tissue repair in total hip arthroplasty.

Dislocation after total hip replacement is more common in the early, postoperative period. Postoperative intraarticular haematoma and remaining seroma fluid and/or weakened posterior soft tissue wall may be contributing factors. Our purpose was to compare and follow with sonography the resorption of the postoperative volume of intraarticular fluid/synovial oedema after total hip arthroplasty (THA) with or without posterior soft tissue repair. Thirty-three consecutive patients with hip osteoarthritis were admitted for THA. All of them received the same type of cemented implant. Patients were randomised for posterior soft tissue repair or not. Sonography, measuring the anterior capsular distension, indicating the volume of intraarticular fluid/synovial oedema in the prosthetic hip joints, was performed after six and 12 months in all patients. At six months postoperatively greater capsular distension, i.e., remaining volume of intraarticular fluid/synovial oedema, was observed in the group with posterior soft tissue repair than in the group without. After one year the capsular distension had decreased in both groups and there was no significant difference between the groups. Our results show that posterior soft tissue repair after THA is associated with increased capsular distension during the first six months. After 12 months the volume of intraarticular fluid/synovial oedema is the same with or without posterior soft tissue repair.

Femoral head diameter affects the revision rate in total hip arthroplasty: an analysis of 1,720 hip replacements with 9-21 years of follow-up.

BACKGROUND: In a previous study concerning 1,660 ScanHip THAs that were followed for up to 12 years, the cumulative revision rate was not found to be dependent on whether a 22-mm or a 32-mm head size had been used. We have re-examined these patients to see whether a longer follow-up time (9-21 years) would disclose an effect of head size on the revision rate. PATIENTS AND METHODS: We analyzed the cumulative revision rate for 1,720 Scan Hip arthroplasties with either 22-mm or 32-mm femoral heads. The patients were followed for 9-21 years. RESULTS: Arthroplasties with 32-mm head had 2.8-times higher cumulative revision rate than those with a 22-mm head. Older age reduced the risk of revision while male sex increased the risk. INTERPRETATION: We found that head size affects revision risk, but that even in a reasonably large material a long follow-up time is required to disclose the effects of head size--and thus wear--on survival.

Is removal of subchondral bone plate advantageous in cemented cup fixation? A randomized RSA study.

UNLABELLED: There is uncertainty regarding whether and how the subchondral bone plate should be treated during acetabular preparation for cemented cup fixation in a total hip arthroplasty. We hypothesized that removing the bone plate would improve the cement-bone interface without jeopardizing the initial cup stability, and therefore, be advantageous to long-term cup survival. We randomized 50 patients with primary osteoarthritis into two groups, one for removal and one for retention of the subchondral bone plate. The patients were evaluated during 2 years followup using repeated radiostereometric examinations, analyses of radiolucent lines, and clinical followups. Patient scoring was done using the Western Ontario and McMaster Universities Osteoarthritis Index, the Short Form-12, and the Harris hip score. Removal of the subchondral bone plate resulted in a superior cement-bone interface with less development of radiolucent lines. The radiostereometry results showed small migrations in both groups. We found no differences in cup stability between groups, although a difference was observed in rotational behavior with the removal group stabilizing in a slightly vertical position whereas the retention group showed slight but progressive rotation into a more horizontal position. No differences were found during clinical followups. Removing the subchondral bone plate, where possible, improves the cement-bone interface without jeopardizing the stability, implying better long-term cup survival. However, it is a more demanding surgical technique. LEVEL OF EVIDENCE: Therapeutic study, Level I (high quality randomized controlled trial with statistically significant difference or no statistically significant difference but narrow confidence intervals). See the Guidelines for Authors for a complete description of levels of evidence.

Migration of the acetabular component: effect of cement pressurization and significance of early radiolucency: a randomized 5-year study using radiostereometry.

BACKGROUND: Cementing technique is a crucial factor in prosthesis fixation. No randomized studies have been published, however, comparing the outcome of conventional fingerpacking with the outcome of pressurization of the cement prior to cup insertion. PATIENTS AND METHODS: We randomized 50 THAs to either fingerpacking or sequential pressurization (including individual pressurization of each anchorage hole) and followed the patients with RSA for 5 years. The penetration of cement into the anchorage holes was measured on digital radiographs. Postoperative radiolucent lines around the cup were correlated to later RSA results. For clinical evaluation, we used SF-36 and HHS. RESULTS: The pressurized group of THAs was more stable regarding changes in inclination. We found no other difference in the migratory behavior. The cement penetration into the anchorage holes was deeper with the pressurization technique than with fingerpacking. For the whole group taken together, there was a strong relation between the presence of radiolucent lines as measured on the postoperative radiograph and later migration observed by RSA at 2 and 5 years. INTERPRETATION: Pressurization of the cement produced better cement penetration and increased the cup stability in terms of changes in inclination. Early findings of radiolucent lines can predict later unfavorable cup migration.

Polyethylene wear in prosthetic hips with loose components.

We measured in vivo polyethylene wear of acetabular cups in 74 patients (83 hips) with Charnley total hip arthroplasties (THA), revised because of aseptic loosening of either the acetabular or femoral component. We analyzed conventional pelvic radiographs of 42 THAs before revision due to loose acetabular components alone and 41 THAs before revision due to loose femoral components alone. The THAs were revised after 10 to 26 years. The mean wear-rate in hips with a loose acetabular components was 0.3 mm/y, whereas in hips with a loose femoral components, it was 0.1 mm/y (P=.0001). The mean total linear wear, as measured on the last available radiographs before revision, was 3.4 mm and 1.5 mm, respectively (P=.0001). A significant difference in linear wear between hips with loose cups and loose stems was seen 1 year after surgery: 0.4 mm/y versus 0.3 mm/y, respectively (P=.05).

The ScanHip total hip arthroplasty: radiographic assessment of 72 hips after 10 years.

We analyzed the radiographic and clinical outcome of the ScanHip total hip arthroplasty in 70 patients after 10 years. The Swedish National Hip Register, in which the end-point of the survival analysis is defined as revisions, reported a 10-year survival rate of 94% with the ScanHip, but in the present series 13% of the femoral stems and 29% of the sockets met the criteria for aseptic loosening. Focal osteolysis was found around 8 sockets (11%) and 23 stems (32%) and had occurred significantly oftener around loose sockets, but not around femoral stems. Linear polyethylene wear was significantly increased in loose sockets, but no relationship was noted between polyethylene wear and stem loosening or was there a correlation between clinical symptoms or patients' satisfaction and component loosening. Therefore precise serial long-term radiographic follow-up is the only satisfactory method for detecting aseptic loosening of total hip arthroplasty. It gives the surgeon more detailed information about each case than survival analysis alone.