The primary aim of this study was to quantify the improvement in patient-reported outcome measures (PROMs) following total hip arthroplasty (THA), as well as the extent of any deterioration through the seven-year follow-up. The secondary aim was to identify predictors of PROM improvement and deterioration. A total of 976 patients were enrolled into a prospective, international, multicentre study. Patients completed a battery of PROMs prior to THA, at three months post-THA, and at one, three, five, and seven-years post-THA. The Harris Hip Score (HHS), the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS), the SF-36 Mental Component Summary (MCS), and the EuroQol five-dimension three-level (EQ-5D) index were the primary outcomes. Longitudinal changes in each PROM were investigated by piece-wise linear mixed effects models. Clinically significant deterioration was defined for each patient as a decrease of one half of a standard deviation (group baseline).Aims
Patients and Methods
Within the field of arthroplasty, the use of patient-reported outcome measures (PROMs) is becoming increasingly ubiquitous in an effort to employ more patient-centered methods of evaluating success. PROMs may be used to assess general health, joint-specific pain or function, or mental health. General and joint-specific questionnaires are most often used in arthroplasty research, but the relationship between arthroplasty and mental health is less well understood. Furthermore, longitudinal reports of PROM changes after arthroplasty are lacking in the literature. Our primary aim was to quantify the improvement in general, joint-specific, and mental health PROMs following total hip arthroplasty (THA) as well as the extent of any deterioration through the 7 years follow-up. Our secondary aim was to identify predictors of clinically significant PROM decline. A total of 864 patients from 17 centers across 8 countries were enrolled into a prospective study. Patients were treated with components from a single manufacturer, which have been shown to be well-functioning in other studies. Patients completed a battery of PROMs preoperatively, and at one, three, five, and seven years post-THA. Changes in PROMs between study visits were assessed via paired tests. Postoperative trends for each PROM were determined for each subject by the slope of the best-fit line of the four postoperative data points. Significant PROM deterioration was defined as one literature-defined minimum clinically important difference over 5-years. Binary logistic regressions were used to identify independent predictors of significant decline in the EuroQol (EQ-5D) visual analogue scale (VAS) for Health State, 36-Item Short Form Survey (SF-36) physical composite summary (PCS), and SF-36 mental composite summary (MCS).Introduction
Methods
Dual Mobility (DM) implants have gained popularity for the treatment and prevention of hip dislocation, with increased stability provided by a large diameter mobile insert. However, distal regions of the insert may impinge on soft tissues like the iliopsoas, leading to groin pain. Additionally, soft-tissue impingement may trap the mobile insert, leading to excessive loading of the insert rim from engagement with the femoral neck and subsequent intra-prosthetic dislocation. To address this, an Anatomically Contoured Dual Mobility (ACDM) insert with a soft-tissue friendly distal geometry was developed Fluoroscopic imaging was used to evaluate soft-tissue interaction with ACDM and conventional DM inserts in four cadaver hips (Introduction
Methods
Osteolysis caused by wear of the ultrahigh molecular weight polyethylene (UHMWPE) often leads to failure. Cross-linking improves wear, but also produces residual free radicals that decrease oxidative stability. 58 patients (64 observed hips), all with osteoarthritis, gave informed consent to participate in a 5 year RSA study. Each patient received a VEPE liner, a Regenerex™ acetabular shell, and an uncemented stem with either a 32mm or 36 mm cobalt chrome femoral head. Tantalum beads were inserted into the VEPE, the pelvic and the femoral bone to measure head penetration into the polyethylene, and shell and stem stability over time, using RSA. RSA radiographs were scheduled immediately postoperatively (up to 6 weeks) and 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks nonparametric test was used to determine if changes in penetration or migration were significant over time at p≤0.05.Introduction
Methods
The Magna ROM 21 knee prosthesis was designed in 1994 to match the anatomical characteristics of the Japanese knee and achieve deep knee flexion to suit Japanese lifestyles. The prosthesis has a smaller anteroposterior mediolateral diameter ratio for the femur and tibia than do knees designed in the United States. The purpose of this study was to review the clinical results of the first 159 arthroplasties performed with this prosthesis in order to asses whether this cementless implant had achieved its design objectives. 159 knees were followed for 12.6 to 14.0 years (mean, 13.4 years). Preoperatively the mean The Knee Society knee score and function score were 24.9 and 27.5 points; postoperatively they were 94.6 and 83.8 points. The mean preoperative and postoperative ranges were 106 and 118 degrees, respectively. Total knee arthroplasty with the Magna ROM 21 resulted in an excellent range of motion and a high level of satisfaction wth the operation.
In Cruciate Retaining (CR) Total Knee Arthroplasty (TKA), the Posterior Cruciate Ligament (PCL) is preserved but the Anterior Cruciate Ligament (ACL) is sacrificed. In contemporary CR implants, failure to substitute for ACL function causes abnormal knee motion, with the femur being located excessively posterior on the tibia in full extension ( The kinematics of an ACL-preserving implant, the ASCR implant, and a contemporary CR implant during deep knee bend was simulated using LifeMOD KneeSIM software (Introduction
Methods
Contemporary PCL sacrificing Total Knee Arthroplasty (TKA) implants (CS) consist of symmetric medial and lateral tibial articular surfaces with high anterior lips designed to substitute for the stability of the native PCL. However, designs vary significantly across implant systems in the level of anteroposterior constraint provided. Therefore, the goal of this study was to investigate kinematics of two CS designs with substantially different constraint levels. The hypothesis was that dynamic knee simulations could show the effect of implant constraint on kinematics of CS implants. LifeModeler KneeSIM software was used to analyze contemporary CS TKA (X) with a symmetric and highly dished tibia and contemporary CS TKA (Y) with a symmetric tibia having flat sections bounded by high anterior and posterior lips, during simulated deep knee bend and chair sit. The flat sections of CS-Y implant are designed to allow freedom prior to motion restriction by the implant lips. Components were mounted on an average knee model created from Magnetic Resonance Imaging (MRI) data of 40 normal knees. Relevant ligament/tendon insertions were obtained from the MRI based 3D models and tissue properties were based on literature values. The condyle center motions relative to the tibia were used to compare the different implant designs. In vivo knee kinematics of healthy subjects from published literature was used for reference.INTRODUCTION
METHODS
Femoral head diameter has a major influence on stability and dislocation resistance of the hip joint after Total Hip Arthroplasty (THA). Dual Mobility (DM) implants can also reduce the risk of dislocation due the large diameter mobile liner which forms the femoroacetbular articulation. However, recent studies have shown that large head prostheses can directly impinge against native soft tissues, particularly the iliopsoas, leading to anterior hip pain. Dual mobility systems have emerged as a revision option in the treatment of failed metal on metal devices because of the high incidence of post revision instability secondary to abductor loss and need for capsulectomy. We hypothesized that an Anatomically Contoured Dual Mobility (ACDM) liner could provide joint stability while better accommodating the soft tissues surrounding the hip joint. The dislocation resistance of a 44 mm ACDM implant was compared to that of a 44 mm conventional DM liner. Both implants consisted of a 28 mm inner small diameter head and the liner was abducted to be in the worst case position for dislocation (Fig. 1). The ACDM liner was based on a 44 mm sphere with smaller radii used to contour the peripheral region below the equator of the liner. MSC Adams was used for dynamic simulations based on two previously described dislocation modes: (A) Posterior dislocation (at 90° hip flexion) with internal rotation of the hip and a posterosuperior directed joint force; (B) Posterior dislocation (starting at 90° flexion) with combined hip flexion and adduction and a posteromedial force direction (Fig. 2). Impingement-free motion (motion without neck impingement against the acetabular cup) and jump distance (head separation from acetabulum at dislocation) were measured for each implant. The acetabular cup was placed at 42.5° abduction and 19.7° anteversion, while the femoral component was anteverted by 9.75° based on published data.INTRODUCTION
METHODS
While kinematic abnormalities of contemporary TKA implants have been well established, a solution has not yet been achieved. We hypothesized that contemporary TKA implants are not compatible with normal soft-tissue function and normal knee motion. We propose a novel technique for reverse engineering advanced implant articular surfaces (biomimetic surface), by using accurate 3D kinematics of normal knees. This technique accounts for surgical placement of the implants, and allows design of tibial and femoral articular surfaces in conjunction. Magnetic resonance imaging was used to create 3D knee models of 40 normal subjects (24 male, 16 female, age 29.9 ± 9.7 years), and bi-planar fluoroscopy was used to capture 3D knee motion during a deep knee bend. These data were combined to create a 3D virtual representation of an average normal knee and its motion pathway. A TKA femoral component was mounted on the average knee, and moved through its normal kinematic pathway to carve out an articular surface from a tibial template (Fig. 1 and 2). The geometry of the resulting biomimetic tibia was compared to that of the native tibia, and a contemporary TKA tibial insert that uses the same femoral component.Introduction:
Methods:
Large diameter femoral heads have been used successfully to prevent dislocation after Total Hip Arthroplasty (THA). However, recent studies show that the peripheral region of contemporary femoral heads can directly impinge against the native soft-tissues, particularly the iliopsoas, leading to activity limiting anterior hip pain. This is because the spherical articular surface of contemporary prosthesis overhangs beyond that of the native anatomy (Fig. 1). The goal of this research was to develop an anatomically shaped, soft-tissue friendly large diameter femoral head that retains the benefits of contemporary implants. Various Anatomically Contoured femoral Head (ACH) designs were constructed, wherein the articular surface extending from the pole to a theta (θ) angle, matched that of contemporary implants (Fig. 2). However, the articular surface in the peripheral region was moved inward towards the femoral head center, thereby reducing material that could impinge on the soft-tissues (Fig. 1 and Fig. 2). Finite element analysis was used to determine the femoroacetabular contact area under peak in vivo loads during different activities. Dynamic simulations were used to determine jump distance prior to posterior dislocation under different dislocation modes. Published data was used to compare the implant articular geometry to native anatomy (Fig. 3). These analyses were used to optimize the soft-tissue relief, while retaining the load bearing contact area, and the dislocation resistance of conventional implants.Introduction:
Methods:
Dual Mobility (DM) hip implants have gained popularity for the treatment and preventions of instability. In DM implants a large diameter mobile insert matches the native femoral head size. However, studies have shown that the peripheral regions of such large diameter implants overhang beyond the native anatomy and can directly impinge against nearby soft tissues, especially the iliopsoas, leading to groin pain (Fig. 1). Soft-tissue impingement can also trap the mobile DM insert, leading to damage of its peripheral rim, which secures the small diameter inner head (Fig. 2). The goal of this research was to develop an anatomically contoured soft-tissue friendly DM insert. Various Anatomically Contoured Dual Mobility (ACDM) insert designs were constructed, wherein the outer articular surface extending from the pole to a theta (θ) angle, matched that of contemporary implants (Fig. 3). However, the articular surface in the peripheral region was moved inward towards the center, thereby reducing implant volume that could impinge on the soft tissue (Fig. 1 and Fig. 3). Finite element analyses were used to determine the insert-acetabular contact area under peak in vivo loads during different activities. Finite element analysis was also used to determine resistance to extraction of the inner head. Published data was used to compare the implant articular geometry to native anatomy. These analyses were used optimize the soft-tissue relief, while matching the load bearing contact area and the resistance to extraction of the inner head in contemporary implants.Introduction:
Methods:
Large diameter femoral heads provide increased range-of-motion and reduced dislocation rates compared to smaller diameter femoral heads. However, several recent studies have reported that contemporary large head prostheses can directly impinge against the local soft tissues leading to anterior hip pain. To address this we developed a novel Anatomically Contoured large diameter femoral Head (ACH) that maintains the profile of a large diameter femoral head over a hemispherical portion and then contours inward the distal profile of the head for soft-tissue relief. We hypothesized that the distal contouring of the ACH articular surface would not affect contact area. The impact of component placement, femoral head to acetabular liner radial clearance, and joint loading during different activities was investigated. A finite element model was used to assess the femoroacetabular contact area of a 36 mm diameter conventional head and a 36 mm ACH (Fig. 1). It included a rigid acetabular shell, plastically deformable UHMWPE acetabular liner, rigid femoral head and rigid femoral stem. The femoral stem was placed at 0°, 10° and 20° of anteversion. The acetabular shell and liner were placed in 20°, 40° and 60° of abduction and 0°, 20° and 40° of anteversion. The femoral head to acetabular liner radial clearances modeled were 0.06 mm, 0.13 mm and 0.5 mm. Three loading cases corresponding to peak in vivo loads during walking, chair sit and deep-knee bend were analyzed (Fig. 2). This allowed a range of component positions and maximum joint loads to be studied.Introduction
Methods
Dual mobility (DM) implants provide increased stability and range-of-motion through the use of a large diameter mobile liner articulating against an acetabular shell. However, recent studies have reported that such contemporary large head prostheses can directly impinge against the local soft tissues leading to anterior hip pain. To address this drawback, a novel Anatomically Contoured Dual Mobility (ACDM) liner was developed that maintains the outer spherical geometry over an approximately hemispherical portion and then contours inward the distal profile of the DM liner for soft-tissue relief. The extent of the inner profile encapsulating the small diameter head is increased to provide more coverage of the head and maintain the inner head pullout force. We hypothesized that the ACDM liner for soft-tissue relief would not affect retention of the small diameter inner head or liner-acetabular load-bearing contact area. A finite element model to evaluate head retention and contact mechanics was created with a rigid acetabular shell, a plastically deformable UHMWPE DM liner, a rigid femoral head and a rigid femoral stem. For the head retention analysis, the extent of head coverage (Fig. 1) was optimized to match the inner head pullout force of a conventional DM liner. Contact mechanics of a conventional DM and ACDM liner were analyzed at the maximum joint load of three activities: gait, deep-knee bend and chair sit. One set of simulations was completed with the mobile liner and head axes aligned and another with the axes mal-aligned so that the mobile liner rim was adjacent to the femoral stem neck and the potential area of contact was away from the mobile liner apex. This allowed a broader range of potential contact to be assessed including what was determined to be a worst-case alignment.Introduction
Methods
Due to technology advancement, many studies have reported on in-vivo human knee kinematics recently (Dannis, 2005; Moro-oka, 2008; Tashman, 2003; Koo, 2008). This abstract summarized the joint kinematics during three motions usually seen in our daily living, i.e. gait, step-up (stair ascending) and single-legged lunge that was measured using a combined dual-fluoroscopic imaging system and MRI based modeling technique (Li, 2008). Cartilage contacts or condylar motion using transepicondylar axis (TEA)/geometric center axis (GCA) were used to describe the motion characters of the knee during these motions. In the treadmill gait, the movement of the medial femoral condyle along the anteroposterior direction was significantly greater than that of the lateral femoral condyle during the stance phase using either TEA (9.7 ± 0.7 mm vs. 4.0 ± 1.7 mm, respectively; p < 0.01; Fig. 1A) or GCA (17.4 ± 2.0 mm vs. 7.4 ± 6.1 mm, respectively; p < 0.01; Fig. 1B). A “lateral-pivoting” of the knee was observed (Kozanek, 2009). In the step-up motion, both medial and lateral contact points moved anteriorly on the tibial articular surfaces along the step-up motion path. The contact points on the medial and lateral tibial plateau moved anteriorly (13.5 ± 3.2 mm vs. 10.7 ± 5.0 mm, respectively; p > 0.05; Fig. 2A) with knee extension. Using the TEA (Fig. 2B), the femoral condylar motions presented a similar pattern as the contact points; nonetheless, using the GCA (Fig. 2C), the femoral condylar motion pattern was dramatically different. The medial condyle moved anteriorly, while the lateral condyle shifted posteriorly. However, none of them showed a significant pivoting phenomenon (Li, 2013). In the single-legged lunge, both medial and lateral contact points moved similarly before 120° of knee flexion, but the lateral contact moved posteriorly and significantly more than the medial compartment in high flexion (1.9 ± 2.1 mm vs. 4.8 ± 2 mm, respectively; p < 0.05). The single-legged lunge didn't show a single motion pattern (Fig. 3) (Qi, 2013). These data provide baseline knowledge for the understanding of normal physiological function of the knee during gait, step-up and lunge activities. The findings of these studies demonstrated that knee joint kinematics is activity-dependent and indicated that the knee joint motions could not be described using a single motion character such as “medial-pivoting” that has recently been popularized in total knee arthroplasty design areas.
Contemporary Posterior Cruciate Ligament (PCL) retaining TKA implants (CR) are associated with well-known kinematic deficits, such as absence of medial pivot motion, paradoxical anterior femoral sliding, and posterior femoral subluxation at full extension. The hypothesis of this study was that a biomimetic implant, reverse engineered by using healthy knee kinematics to carve the tibial articular surface, could restore normal kinematic patterns of the knee. Kinematics of the biomimetic CR and two contemporary CR implants (A, B) were evaluated during simulated deep knee bend and chair-sit in LifeModeler KneeSIM™ software. Anteroposterior motion of the medial and lateral femoral condyle centers was measured relative to a tibial origin. The implants were mounted on an average knee model created from magnetic resonance imaging (MRI) of 40 healthy knees. The medial and lateral collateral ligaments, posterior cruciate ligament, quadriceps mechanism, and the overall capsular tension were modeled. The soft-tissue insertions were obtained from the average knee model, and the mechanical properties were obtained from literature. In vivo knee kinematics of healthy subjects from published literature was used for reference.Introduction:
Methods:
Acetabular cup position is an important factor in successful total hip arthroplasty (THA). Optimal cup placement requires surgeons to possess an accurate perception of pelvic orientation during cup impaction, however, varying pelvic anatomy and limited visual cues in the surgical field may interfere with this process. The purpose of this study was to evaluate the utility of an inertial measurement unit (IMU) in monitoring pelvic position during THA. Ten patients scheduled to undergo THA were IRB-approved and consented by four surgeons. A small IMU was placed over the patient's sacrum pre-operatively and zeroed in standing position. Pelvic orientation data was streamed and captured wirelessly throughout the procedure. Surgeons were blinded to all data throughout the study period. Prior to cup impaction, the surgeon indicated his intended cup abduction angle and the degree to which the cup impactor was manipulated to compensate for perceived AP pelvic tilt. The degree of pelvic tilt as determined by the IMU (angle β) was then recorded (Figure 1). AP-pelvis radiographs were measured in Martell Hip Analysis Suite post-operatively to calculate the cup abduction angle, which was then compared to the surgeon's intended abduction angle to determine surgeon accuracy. To predict the final cup abduction angle, the degree of pelvic tilt recorded by the IMU (angle β) was subtracted from the abduction angle of the cup impactor (angle α) that was positioned using the OR table as a reference (Figure 1). This value was then compared to the measured post-operative cup abduction angle in order to assess the accuracy of the IMU in measuring pelvic tilt. Surgeon accuracy and IMU accuracy were compared to determine if the IMU was more or less effective than surgeon perception at determining pelvic tilt.Introduction:
Materials & Methods:
ACL retaining (BCR) Total Knee Arthroplasty (TKA) provides more normal kinematics than ACL sacrificing (CR) TKA. However, in the native knee the ACL and the asymmetric shape of the tibial articular surface with a convex lateral plateau are responsible for the differential medial/lateral femoral rollback (medial pivot). Therefore, the hypothesis of this study was that an asymmetric biomimetic articular surface together with ACL preservation would better restore native knee kinematics than retention of the ACL alone. Normal knee kinematics from bi-planar fluoroscopy was used to reverse engineer the tibial articular surface of the biomimetic implant. This was achieved by moving the femoral component through the healthy knee kinematics and removing material from a tibial template. LifeModeler KneeSIM software was used to analyze a biomimetic BCR implant (asymmetric tibia with convex lateral surface), a contemporary BCR (symmetric shallow dished tibia) and a contemporary CR (symmetric dished tibia) implant during simulated deep knee bend and chair sit. Components were mounted on an average bone model created from Magnetic Resonance Imaging (MRI) data of 40 normal knees. The soft-tissue insertions were obtained from the average knee model and the mechanical properties were obtained from literature. Femoral condyle center motions relative to the tibia were used to compare different implant designs. In vivo knee kinematics of healthy subjects from published literature was used for reference.INTRODUCTION
METHODS
Femoral head diameter has a major influence on stability and dislocation resistance after Total Hip Arthroplasty (THA). Although routine use of large heads is common, several recent studies have shown that contemporary large head prostheses can directly impinge against native soft tissues, particularly the iliopsoas which wraps around the femoral head, leading to refractory anterior hip pain. To address this, we developed a novel Anatomically Contoured large diameter femoral Head (ACH). We hypothesized that anatomical contouring of the ACH implant for soft tissue relief would not compromise dislocation resistance, and the ACH implant would provide increased stability compared to small heads. In this study the dislocation resistance of a 36 mm ACH was compared to that of 28 mm and 36 mm contemporary heads. The ACH implant was based on a 36 mm sphere with smaller radii used to contour the peripheral region below the equator of the head. MSC Adams was used for dynamic simulations based on two previously described dislocation modes: (A) Posterior dislocation (at 90° hip flexion) with internal rotation of the hip and a posterosuperior directed joint force; (B) posterior dislocation (starting at 90° flexion) with combined hip flexion and adduction and a posteromedial force direction (Fig. 1). Impingement-free motion (motion without neck impingement against the acetabular liner) and jump distance (head separation from acetabulum prior to dislocation) were measured to evaluate the dislocation risk of each implant. The acetabular cup was placed at 42.5° abduction and 19.7° anteversion, while the femoral component was anteverted by 9.75° based on published data.INTRODUCTION
METHODS
