Comparison between model-based RSA and an AI-based CT-RSA: an accuracy study of 30 patients.

BACKGROUND AND PURPOSE: Radiostereometry (RSA) is the current gold standard for evaluating early implant migration. CT-based migration analysis is a promising method, with fewer handling requirements compared with RSA and no need for implanted bone-markers. We aimed to evaluate agreement between a new artificial intelligence (AI)-based CT-RSA and model-based RSA (MBRSA) in measuring migration of cup and stem in total hip arthroplasty (THA). PATIENTS AND METHODS: 30 patients with THA for primary osteoarthritis (OA) were included. RSA examinations were performed on the first postoperative day, and at 2 weeks, 3 months, 1, 2, and 5 years after surgery. A low-dose CT scan was done at 2 weeks and 5 years. The agreement between the migration results obtained from MBRSA and AI-based CT-RSA was assessed using Bland-Altman plots. RESULTS: Stem migration (y-translation) between 2 weeks and 5 years, for the primary outcome measure, was -0.18 (95% confidence interval [CI] -0.31 to -0.05) mm with MBRSA and -0.36 (CI -0.53 to -0.19) mm with AI-based CT-RSA. Corresponding proximal migration of the cup (y-translation) was 0.06 (CI 0.02-0.09) mm and 0.02 (CI -0.01 to 0.05) mm, respectively. The mean difference for all stem and cup comparisons was within the range of MBRSA precision. The AI-based CT-RSA showed no intra- or interobserver variability. CONCLUSION: We found good agreement between the AI-based CT-RSA and MBRSA in measuring postoperative implant migration. AI-based CT-RSA ensures user independence and delivers consistent results.

Tibial Component Undersizing Is Related to High Degrees of Implant Migration Following Cementless Total Knee Arthroplasty: A Study of Radiostereometric Analysis Data for 111 Patients with 2-Year Follow-up.

Radiostereometric analysis (RSA) studies have shown that the continuous migration of tibial components is predictive of aseptic loosening following total knee arthroplasty (TKA). In the present study, we investigated whether accurate sizing and placement of tibial components are related to the degree of implant migration as measured with use of RSA. Methods: A total of 111 patients who underwent TKA surgery with a cementless tibial component were followed for a period of 2 years postoperatively, during which implant migration was assessed with use of RSA. RSA was performed within 7 days postoperatively and after 3, 6, 12, and 24 months. Postoperative radiographs were evaluated for component size and placement in the tibia. The evaluations were performed by experienced knee surgeons who were blinded to the migration data and clinical outcomes. A multivariable linear regression analysis was conducted. Results: Continuous implant migration (i.e., migration occurring between 12 and 24 months postoperatively) had a negative association with tibial component size (coefficient [B], -0.2; 95% confidence interval [CI], -0.33 to -0.08). Subsidence was associated with the absence of posterior cortical bone support (B, -0.7; 95% CI, -1.09 to -0.28), the absence of lateral cortical bone support (B, 0.8; 95% CI, 0.29 to 1.37), frontal-plane varus malalignment (B, 0.6; 95% CI, 0.12 to 1.16), and component undersizing (B, -0.4; 95% CI, -0.06 to -0.68). Posterior tilt was associated only with undersizing (B, 0.6; 95% CI, 0.27 to 1.11). Conclusions: Undersized cementless tibial components are at a higher risk for poor fixation with continuous migration following TKA. Therefore, a higher risk of aseptic loosening should be expected. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Implant migration and functional outcome of Reverse Shoulder Lateralized Glenosphere Line Extension System: a study protocol for a randomized controlled trial.

BACKGROUND: Inferior scapular notching is a complication unique to reverse shoulder arthroplasty. The most efficient technique to avoid inferior scapular notching has been reported to be lateralization of the glenoid offset. This study aims to compare radiological and functional outcomes of the DELTA Xtend® Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) with the Standard DELTA Xtend® Reverse Shoulder System (control group). We hypothesize that the lateralization improves the patient outcome by decreasing the risk of inferior scapular notching without increasing the risk of migration and loosening of glenoid component. METHODS: In this randomized controlled trial, all Danish citizens with rotator cuff arthropathy or degeneration of the glenohumeral joint with severe posterior wear and allocated for a reverse total shoulder arthroplasty at the department of orthopaedic surgery at Herlev and Gentofte Hospital, Copenhagen University Hospital, will be considered for participation. The exclusion criteria are as follows: below 50 years of age, cognitive or linguistic impairment, insufficient glenoid bone stock, previous fracture in the upper extremity and autoimmune-mediated inflammatory arthritis. There will be included a total of 122 patients of which 56 will participate in the radiostereometric analysis. This number of patients allows 20% to drop out. The co-primary outcomes are the pattern and magnitude of the migration of the glenoid component assessed by radiostereometric analysis and the Western Ontario Osteoarthritis of the Shoulder index. The secondary outcomes are inferior scapular notching, patient-reported and functional outcomes (Oxford shoulder score, Constant-Murley score and pain), side effects and complications, changes in bone mineral density and economy. The included patients will be examined before the surgery, within 1 week and 3, 6, 12 and 24 months after. DISCUSSION: No previous studies have compared the conventional reverse shoulder arthroplasty with the lateralized reverse shoulder arthroplasty in a randomized controlled trial regarding migration and functional outcome. Furthermore, radiostereometric analysis has not been used to evaluate the migration of reverse shoulder arthroplasty in a randomized controlled trial. This study intends to determine which treatment has the most optimal outcome for the benefit of future patients with an indication for reverse shoulder arthroplasty. TRIAL REGISTRATION: The study has been notified to Pactius and has approval number P-2021-231. Furthermore, the study will be registered on Clinicaltrials.gov before starting the inclusion.

Vitamin E infused highly cross-linked cemented cups in total hip arthroplasty show good wear pattern and stabilize satisfactorily: a randomized, controlled RSA trial with 5-year follow-up.

Background and purpose - Vitamin E infused highly cross-linked polyethylene (VEPE) was introduced in order to enhance oxidative resistance in highly cross-linked polyethylene cups in total hip arthroplasty (THA). We have, with a follow-up of 5 years, evaluated wear characteristics of 2 identically designed cemented cups with the only difference being the material, VEPE or ultra-high molecular weight polyethylene (UHMWPE). Furthermore, we report cup migration and clinical outcome. Patients and methods - 48 patients with primary osteoarthritis were randomized to either UHMWPE or VEPE cups. Patients were followed with radiostereometric analysis (RSA) from the first postoperative day, at 3 months, 1, 2, and 5 years as well as with hip-specific outcome questionnaires. Results - At 3 months the mean proximal head penetration for UHMWPE was 0.07 mm (95% CI 0.03-0.11) and for VEPE 0.06 mm (-0.01 to 0.13). Thereafter, there was a continuous annual wear of 0.08 mm/year, up to 0.46 mm (0.36-0.57) at 5 years, for the UHMWPE cup. The VEPE cup showed low annual wear of 0.01 mm/year, up to 0.09 mm (0.02-0.16) at 5 years. In the first 3 months the UHMWPE cup migrated cranially 0.08 mm (0.03-0.13) whereas the VEPE cup migrated 0.17 mm (0.10-0.24), Thereafter, they showed similar migration patterns with stabilization between 2 and 5 years up to 0.21 mm (0.04-0.39) and 0.24 mm (0.13-0.36) respectively. The HOOS remained good up to 5 years, and no cup was revised. Interpretation - Compared with otherwise identical UHMWPE cups the cemented VEPE cup shows statistically significant reduction of wear up to 5 years and both cup types stabilize well with good clinical outcome.

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.

Preserved periprosthetic bone stock at 5 years post-operatively with uncemented short hip stem in both collared and collarless version.

INTRODUCTION: Previous bone density studies have generally shown bone resorption around both cemented and uncemented total hip arthroplasty (THA) stems. This is presumed to be due to stress shielding. Short stems have been introduced partly to preserve bone in the proximal femur by a more physiological loading of the bone. The purpose of this study was to evaluate bone remodeling around a short, fully hydroxyapatite-coated titanium stem that comes in a collared and collarless version. PATIENTS AND METHODS: A prospective cohort of 50 patients included in a study evaluating the Furlong Evolution stem has been followed for 5 years. Examination was done with dual energy X-ray absorptiometry (DXA) postoperatively, at 1, 2 and 5 years. Clinical outcome was followed with radiography and both general and hip specific outcome measures. RESULTS: The two versions of the stem behaved similarly regarding bone remodeling. After an initial decrease up to 1 year, bone mineral density (BMD) increased in all Gruen zones up to 2 years and at 5 years bone stock was still preserved compared with postoperatively (net BMD + 1.2% (95% CI - 0.4 to 2.8)). Increase in BMD occurred mainly in the greater trochanter and distally around the stem with a decrease in the calcar area. Both versions showed excellent clinical outcome up to 5 years. CONCLUSION: This short stem seems to preserve proximal bone stock up to 5 years, exhibiting similar behaviour both with and without a collar. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ClinicalTrials.gov, (identifier: NCT01894854). July 10, 2013.

Bone remodeling and implant migration of uncemented femoral and cemented asymmetrical tibial components in total knee arthroplasty - DXA and RSA evaluation with 2-year follow up.

BACKGROUND: Aseptic loosening is one of the major reasons for late revision in total knee arthroplasty (TKA). The risk of aseptic loosening can be detected using radiostereometric analysis (RSA), whereby micromovements (migration) can be measured, and thus RSA is recommended in the phased introduction of orthopedic implants. Decrease in bone mineral density (BMD), as measured by dual-energy x ray absorptiometry (DXA), is related to the breaking strength of the bone, which is measured concurrently by RSA. The aim of the study was to evaluate bone remodeling and implant migration with cemented asymmetrical tibial and uncemented femoral components after TKA with a follow up period of 2 years. METHODS: This was a prospective longitudinal cohort study of 29 patients (number of female/male patients 17/12, mean age 65.2 years), received a hybrid Persona® TKA (Zimmer Biomet, Warsaw, IN, USA) consisting of a cemented tibial, an all-polyethylene patella, and uncemented trabecular metal femoral components. Follow up: preoperative, 1 week, and 3, 6, 12 and 24 months after surgery, and double examinations for RSA and DXA were performed at 12 months. RSA results were presented as maximal total point of motion (MTPM) and segmental motion (translation and rotation), and DXA results were presented as changes in BMD in different regions of interest (ROI). RESULTS: MTPM at 3, 6, 12, and 24 months was 0.65 mm, 0.84 mm, 0.92 mm, and 0.96 mm for the femoral component and 0.54 mm, 0.60 mm, 0.64 mm, and 0.68 mm, respectively, for the tibial component. The highest MTPM occurred within the first 3 months. Afterwards most of the curves flattened and stabilized. Between 12 and 24 months after surgery, 16% of femoral components had migrated by more than 0.10 mm and 15% of tibial components had migrated by more than 0.2 mm. Percentage change in BMD in each ROI for distal femur was as follows: ROI I 26.7%, ROI II 9.2% and ROI III 3.3%. BMD and at the proximal tibia: ROI I 8.2%, ROI II 8.6% and ROI III 7.0% after 2 years compared with 1 week postoperative results. There was no significant correlation between maximal percentwise change in BMD and MTPM after 2 years. CONCLUSION: Migration patterns and changes in BMD related to femoral components after TKA in our study correspond well with previous studies; we observed marginally greater migration with the tibial component.

Highly cross-linked polyethylene still outperforms conventional polyethylene in THA: 10-year RSA results.

Background and purpose - Cup wear in total hip arthroplasty (THA) can be affected by different manufacturing processes of the polyethylene (PE). We report the long-term wear pattern differences, as well as early creep behavior, between conventional PE and highly cross-linked PE (HXLPE) liners, as measured with radiostereometry (RSA) up to 10 years. We also compare migration and clinical outcome of 2 similar uncemented cups with different backside surface roughness.Patients and methods - We included 45 patients with primary osteoarthritis. 23 received a conventional liner and 22 an HXLPE liner in a similar uncemented cup, but with a slightly rougher surface. The patients were followed up with RSA and hip-specific outcome questionnaire (HOOS) at 3 months, 1, 2, 5, and 10 years.Results - During the first 3 months both liners showed expected deformation with mean proximal head penetration of 0.39 mm (conventional PE) and 0.21 mm (HXLPE). Between 3 months and 10 years there was a difference in annual wear with 0.12 mm/year for the conventional liner and 0.02 mm/year for the HXLPE liner. The cup with rougher surface had less initial migration but both types had stabilized after 3 months. The HOOS scores improved after surgery and remained high for both groups throughout the study period.Interpretation - Up to 10 years the HXLPE has consistent lower annual wear, possibly contributing to longer survival of the THA, compared with conventional PE. All patients reported good results regardless of liner type.

Preoperative BMD does not influence femoral stem subsidence of uncemented THA when the femoral T-score is > -2.5.

Background and purpose - It is believed that in uncemented primary total hip arthroplasty (THA) the anchorage of the stem is dependent on the level of bone mineral density (BMD) of the femoral bone. This is one of the reasons for the widely accepted agreement that a cemented solution should be selected for people with osteoporosis or age > 75 years. We evaluated whether preoperative BMD of the femur bone is related to femoral stem migration in uncemented THA.Patients and methods - We enrolled 62 patients (mean age 64 years (range 49-74), 34 males) scheduled for an uncemented THA. Before surgery we undertook DEXA scans of the proximal femur including calculation of the T- and Z-scores for the femoral neck. Evaluation of stem migration by radiostereometric analysis (RSA) was performed with 24 months of follow-up. In 56 patients both preoperative DEXA data and RSA data were available with 24 months of follow-up.Results - None of the patients had a T-score below -2.5. We found no statistically significant relationship between preoperative BMD and femoral stem subsidence after 3 or 24 months. When comparing the average femoral stem subsidence between 2 groups with T-score > -1 and T-score ≤ -1, respectively, we found no statistically significant difference after either 3 or 24 months when measured with RSA.Interpretation - In a cohort of people ≤ 75 years of age and with local femur T-score > -2.5 we found no relationship between preoperative BMD and postoperative femoral stem subsidence of a cementless THA.

Evaluation of different coatings of the tibial tray in uncemented total knee arthroplasty. A randomized controlled trial with 5 years follow-up with RSA and DEXA.

BACKGROUND: Regenerex® is a porous titanium construct with a 3D interconnecting pore structure and biomechanical characteristics close to that of normal trabecular bone. This study aimed to compare the Regenerex (VR) to the non-interconnecting pore structure Porous Plasma Spray (VP) on tibial implants for total knee arthroplasty (TKA) at 5 years. METHODS: We enrolled and randomized 61 patients (mean age = 63(49-71) years, Female/Male = 35/26) who were planned for an uncemented Vanguard TKA (Biomet, Warsaw, Indiana, USA) to receive either a VR or a VP coated tibial component (31/29). We performed radiostereometric analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) postoperatively, and at three, six, 12, 24 and 60 months with measurements of migration. In total 55 patients attended the 5-year follow-up. RESULTS: One patient died and four were reoperated during the 60-months period; none due to aseptic loosening. All reoperations were in the VR-group. The mean (range) 60-months MTPM was 1.4 mm (0.5-3.7) for the VP-group and 1.8 mm (0.4-4.9) for the VR-group (p = 0.8). The 24 to 60-months mean (range) MTPM was -0.3 mm (-5 to 1.24) in the VP-group and 0.2 mm (-0.4 to 3.5) in the VR-group (p = 0.8). CONCLUSION: We did not find any statistically significant differences between the VP- and VR-group and both groups show recognizable migration. We will continue to follow the groups for years to come.

Migration pattern of a short uncemented stem with or without collar: a randomised RSA-study with 2 years follow-up.

BACKGROUND: There is an increasing interest in shorter, proximally loading, uncemented femoral stems. The aim of this study was to evaluate a new short stem type, its design based on a well-proven precursor, but with several new design features to facilitate easier insertion and possible preservation of proximal bone stock. It is available with or without a collar. METHODS: The study includes 50 patients with primary osteoarthritis, mean age 59 (range 36-75) years, randomised to receive either the collar-fitted or the collarless stem. The patients underwent repeated radiostereometry (RSA) examinations (0, 0.5, 3, 12, 24 months), conventional radiography and filled out both hip-specific (HOOS) and general health (EQ-5D) questionnaires. RESULTS: There was no statistically significant difference between the collared and collarless stems regarding migration and clinical outcome. Both stem types exhibit a similar pattern of initial subsidence (collared 0.63 mm vs. collarless 0.75 mm [p = 0.50]) and retroversion (collared 0.71° vs. collarless 0.97° [p = 0.36]) up to 3 months followed by stabilisation, in similarity with its precursors, suggesting good osseointegration. No stem has been revised or considered loose. CONCLUSIONS: The new design features, including shortening the stem, do not compromise migration pattern or osseointegration, regardless collar or not.

Custom-made 3D-printed cup-cage implants for complex acetabular revisions: evaluation of pre-planned versus achieved positioning and 1-year migration data in 10 patients.

Background and purpose - The use of custom-made 3D-printed titanium implants for the reconstruction of large acetabular defects has been successively introduced in the last decade. In an observational cohort study we evaluated the agreement between preoperatively planned and actually achieved cup-cage position as well as 1-year follow-up migration of the cup-cage component.Patients and methods - 10 patients with Paprosky III defects underwent revision surgery using a custom-made 3D-printed cup-cage. The position of the implant on postoperative CT scan was compared with the preoperative plan and the postoperative CT scan was compared with the 1-year follow-up CT scan.Results - There was a median deviation in postoperative position versus planned in inclination of 3.6° (IQR 1.0-5.4), in anteversion of -2.8° (IQR -7.5 to 1.2), and in rotation of -1.2° (IQR -3.3 to 0.0). The median deviation in position of the center of rotation (COR) was -0.5 mm (IQR 2.9 to 0.7) in the anteroposterior (AP) plane, -0.6 mm (IQR -1.8 to -0.1) in the mediolateral (ML) plane, and 1.1 mm (IQR -1.6 to 2.8) in the superoinferior (SI) plane. The migration between postoperative and 1-year follow-up caused a mean change in inclination of 0.04° (IQR -0.06 to 0.09), in anteversion of -0.13° (IQR -0.23 to -0.06), and in rotation of 0.05° (IQR -0.46 to 1.4). The migration of COR was -0.08 mm (IQR -0.18 to -0.04) in the AP plane, 0.14 mm (IQR -0.08 to 0.22) in the ML plane, and 0.06 mm (IQR -0.02 to 0.35) in the SI plane. There was no re-revision.Interpretation - The early results show good agreement between planned and achieved cup-cage position and small measured migration values of the cup-cage component at the 1-year follow-up.

Unexpected varus deformity and concomitant metal ion release and MRI findings of modular-neck hip stems: descriptive RSA study in 75 hips with 8 years' follow-up.

Background and purpose - Modular-neck hip stems have been identified with corrosion-related problems from the neck-stem junction. We report an ongoing varus deformity of modular-neck hip stems with simultaneous metal ion release observed during a study comparing the migration of modular vs. standard hip stems.Patients and methods - We followed 50 patients with modular and 25 with standard neck stems using radiostereometry (RSA). At 5-year follow-up, we noted a compromised integrity of the modular stem with varus deformity in the neck-stem interface. Changes in head-tip distance as well as whole-blood ion concentration and MRI findings were analyzed. The modular stems were followed further up to 8 years.Results - The head-tip distance decreased continuously by 0.15 mm per year resulting in 1.2 (95% CI 1.0-1.4) mm at 8 years for modular stems, while for the standard stems at 5 years, the decrease was 0.09 (CI 0.0-0.2) mm or 0.02 mm/year. For the modular stems, the reduction in head-tip distance correlated to the increase in whole-blood cobalt concentration at 8 years but not to the MRI grading of tissue reactions. At 5 years, cobalt levels were 4.9 µg/L for modular stems and at 8 years 4.8 µg/L, whereas for standard stems this was 1.0 µg/L. After 8 years, 9 of 72 stems had been revised for different reasons, but only 1 with obvious adverse local tissue reaction (ALTR).Interpretation - We present a surprisingly large progressive deformation at the modular neck-stem junction, but so far without a definite clinical problem. Even the femoral head seems to show slight compression onto the taper over time. A high rate of revisions for the modular type of this stem has raised general concerns, and it has been recalled from the market.

Pre- and postoperative offset and femoral neck version measurements and validation using 3D computed tomography in total hip arthroplasty.

BACKGROUND: Restoration of a correct biomechanical situation after total hip arthroplasty is important. PURPOSE: To evaluate proximal femoral symmetry of acetabular and femoral offset and femoral neck anteversion pre- and postoperatively in hip arthroplasty by semi-automated 3D-CT and to validate the software measurements by inter- and intraobserver agreement calculations. MATERIAL AND METHODS: In low-dose CT on 71 patients before and after unilateral total hip arthroplasty, two observers used a digital 3D templating software to measure acetabular offset, true and functional femoral offset, and femoral neck anteversion. Observer agreements were calculated using intraclass correlation. Hip measurements were compared in each patient and between pre- and postoperative measurements. RESULTS: Preoperatively, acetabular offset (2.4 mm), true (2.2 mm), and functional global offset (2.7 mm) were significantly larger on the osteoarthritic side without side-to-side differences for true and functional femoral offset or femoral neck anteversion. Postoperatively, acetabular offset was significantly smaller on the operated side (2.1 mm) with a concomitantly increased true (2.5 mm) and functional femoral offset (1.5 mm), resulting in symmetric true and functional global offsets. There were no differences in postoperative femoral neck anteversion. Inter- and intraobserver agreements were near-perfect, ranging between 0.92 and 0.98 with narrow confidence intervals (0.77-0.98 to 0.94-0.99). CONCLUSION: Acetabular and concomitantly global offset are generally increased in hip osteoarthritis. Postoperative acetabular offset was reduced, and femoral offset increased to maintain global offset. 3D measurements were reproducible with near-perfect observer agreements. 3D data sets should be used for pre- and postoperative measurements in hip arthroplasty.

Early migration of stemless and stemmed humeral components after total shoulder arthroplasty for osteoarthritis-study protocol for a randomized controlled trial.

BACKGROUND: Glenohumeral osteoarthritis can, in the most severe cases, require surgery with insertion of a shoulder arthroplasty. A design with a stem in the humeral bone canal is currently regarded as the standard treatment option in patients who have an intact rotator cuff function, but complications related to the stem including humeral fractures can have devastating consequences. By using a stemless humeral component, stem-related complications can be reduced. The aim of this study is to compare the Comprehensive Nano stemless total shoulder arthroplasty (intervention group) with the Comprehensive stemmed total shoulder arthroplasty (control group). MATERIALS AND METHODS: This is a randomized controlled trial comparing the stemless and the stemmed total shoulder arthroplasty. All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be offered participation. The following exclude from participation: below 18 years of age, cognitive or linguistic impairment, insufficient function of the rotator cuff, poor bone quality, and ASA groups 4-5. A total of 122 patients will be included of which 56 will be part of a radiostereometric analysis (RSA) study of humeral component migration. The primary outcomes are magnitude of migration of the humeral component assessed by RSA and patient-reported outcome by Western Ontario Osteoarthritis of the Shoulder index (WOOS). The secondary outcomes are additional patient-reported outcomes, functional outcome, readmission, complications, revisions, and changes in bone mineral density (BMD) of the proximal humerus assessed by duel energy x-ray absorptiometry (DXA) and economy (cost-utility analysis). The patients are examined before the operation and 3, 6, 12, and 24 months postoperative. DISCUSSION: To our knowledge, RSA has never been used to access migration of a stemmed or a stemless humeral component nor has the stemmed and the stemless humeral component been compared with regard to pain relief and shoulder function in a randomized clinical trial. Today, the two designs are considered equal in the treatment of osteoarthritis. The study will provide surgeons and patients with information about shoulder arthroplasty for osteoarthritis and assist them in decision-making. TRIAL REGISTRATION: ClinicalTrials.gov NCT04105478 . Registered on 25 September 2019.

Migration of the uncemented Echo Bi-Metric and Bi-Metric THA stems: a randomized controlled RSA study involving 62 patients with 24-month follow-up.

Background and purpose - Despite the good results after total hip arthroplasty (THA), new implants are continuously being developed to improve durability. The Echo Bi-Metric (EBM) THA stem is the successor to the Bi-Metric (BM) THA stem. The EBM stem includes many of the features of the BM stem, but minor changes in the design might improve the clinical performance. We compared the migration behavior with radiostereometric analysis (RSA) of the EBM stem and the BM stem at 24 months and evaluated the clinical outcome. Patients and methods - We randomized 62 patients with osteoarthritis (mean age 64 years, female/male 28/34) scheduled for an uncemented THA to receive either an EBM or a BM THA stem. We performed RSA within 1 week after surgery and at 3, 6, 12, and 24 months. The clinical outcome was evaluated using Harris Hip Score (HHS) and Oxford Hip Score (OHS). Results - At 24 months, we found no statistically significant differences in migration between the two implants. During the first 3 months both the EBM and the BM stems showed visible subsidence (2.5 mm and 2.2 mm respectively), and retroversion (2.5° and 2.2° respectively), but after 3 months this stabilized. The expected increase in HHS and OHS was similar between the groups. Interpretation - The EBM stem showed a migration at 24 months not different from the BM stem, and both stems display satisfying clinical results.

Polyethylene Wear With Ceramic and Metal Femoral Heads at 5 Years: A Randomized Controlled Trial With Radiostereometric Analysis.

BACKGROUND: A common bearing combination in total hip arthroplasty today is a metal femoral head articulating with polyethylene in the cup. Ceramic heads are thought to be more resistant to third-body damage, and have better wettability and decreased surface roughness, which taken together have been suggested to result in less polyethylene wear. The purpose of this study is to compare the initial creep deformation and follow wear pattern, using radiostereometric analysis, of ceramic and metal femoral heads that articulate with a modern highly cross-linked polyethylene cup liner. METHODS: Fifty patients with primary osteoarthritis and scheduled for an uncemented total hip arthroplasty were randomized 1:1 to either a ceramic (BIOLOX delta) or a metal (CoCr) femoral head. The patients were followed up for 5 years with repeated radiostereometric analysis examinations (postoperatively, then at 14 days, 3, 12, 24, and 60 months), as well as a hip-specific outcome questionnaire. RESULTS: During the first 3 months both groups showed expected creep within the liner of 0.12 mm (standard deviation 0.03) for the ceramic and 0.08 mm (standard deviation 0.02) for the metal heads. Between 3 months and 5 years there was very little wear of the liner in either group, corresponding to 0.003 mm/y for ceramic and 0.007 mm/y for metal heads. There was no difference in cup migration or clinical outcome between the groups and no cups were revised. CONCLUSION: With the introduction of modern highly cross-linked polyethylene, the ceramic head demonstrates no superiority when it comes to either early deformation or polyethylene wear compared with the metal head.

Effect of symmetrical restoration for the migration of uncemented total hip arthroplasty: a randomized RSA study with 75 patients and 5-year follow-up.

BACKGROUND: Inferior placement of a femoral stem is predictive for early loosening and failure, but does restoration of the original hip anatomy benefit the function and survival of a total hip replacement? METHODS: Seventy-five patients with primary unilateral hip osteoarthritis operated with an uncemented anatomical stem were randomized for either standard or modular stems. We used 50 ABG II stems with modular necks and 25 standard stems (control group). We measured the symmetry in hip anatomy between healthy and operated side. The anatomical restoration variables were anteversion, global offset, and femoral offset/acetabular offset (FO/AO) quota. We performed measurements using a CT-based 3D templating and measuring software. Migratory behavior of the stems was then measured postoperatively with repeated radiostereometry (RSA) examinations over 5 years. RESULTS: Both stem types showed an early (within 3 months) good stabilization after an initial slight rotation into retroversion and subsidence. There were no significant differences in RSA migration between modular and standard stems. Postoperative anteversion and FO/AO quota had no impact on stem migration. The standard stem tended to result in insufficient global offset (GO), whereas the modular stem did not. CONCLUSIONS: The modular stem gave good symmetrical anatomical restoration and, like the standard version, a benign migratory behavior. Anteversion, GO, and FO/AO quota had no significant impact on stem migration. It therefore seems to be of no importance whether we choose a modular or a standard stem with regard to postoperative stem migration for this stem type. We overestimated the effect anatomical parameters have on stem movement; hence, we believe the study to be underpowered. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01512550. Registered 19 January 2012-retrospectively registered.

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.