Introduction

The Exeter cemented polished tapered stem design was introduced into clinical practice in the early 1970's. [i] Design and cement visco-elastic properties define clinical results [ii]; a recent study by Carrington et al. reported the Exeter stem has 100% survivorship at 7 years. [iii] Exeter stems with offsets 37.5–56 mm have length 150 mm (shoulder to tip). Shorter stems, lengths 95–125 mm, exist in offsets 30–35.5 mm. The Australian National Joint Replacement Registry recently published that at 7 years the shorter stems are performing as well as longer stems on the registry [iv]. Clinical observation indicates in some cases of shorter, narrower femora that fully seating a 150 mm stem's rasp in the canal can be difficult, which may affect procedural efficiency. This study investigates the comparative risk of rasp distal contact for the Exeter 150 mm stem or a 125 mm stem.

INTRODUCTION:

Recreating the natural head center of the hip joint during hip arthroplasty is important for restoring biomechanics in order to minimize leg length discrepancies, improve soft-tissue tension, and mitigate impingement [1,2]. New tools have been developed that allow anatomical measurements and analysis of three-dimensional digital femura geometry based on CT scans [3]. The purpose of this study is to analyze the head center location of various fit-and-fill hip stem designs in relation to the natural bone head center location using a novel technique.

INTRODUCTION

Immediate post-operative stability of a cementless hip design is one of the key factors for osseointegration and therefore long-term success [1]. This study compared the initial stability of a novel, shortened, hip stem to a predicate standard tapered wedge stem design with good, long-term, clinical history. The novel stem is a shortened, flat tapered wedge stem design with a shape that was based on a bone morphology study of 556 CT scans to better fit a wide array of bone types [2].

Introduction

The origins of the uncemented tapered wedge hip stem design currently offered by several orthopaedic device companies can be linked back to the cemented Straight Mueller type stem design first used in 1977. The design, a wedge shape with a taper angle of 6 degrees, maintains a single medial curvature for all sizes and increases laterally in the width to accommodate different size femurs. Although evolutionary improvements have been made over the years the basic body geometry of the stem has stayed mainly unchanged with excellent clinical survivorship. Over the past decade, the demographics of hip replacement have changed, with a large increase in younger male patients in the age range of 40 to 60 years. In this study the femoral fit of a novel tapered stem, designed to fit a wide array of patient types, is compared to a standard predicate tapered stem design.

The current decade has seen a marked rise in popularity of minimally invasive hip replacement, done through a variety of surgical approaches. A specific downside to the direct anterior approach includes the significant difficulty getting a “straight shot” down the femoral canal for either straight, nonflexible reaming or broaching as with standard approaches. Improper alignment in the femoral canal can lead to sub-optimal load transfer and thus compromised fixation. The femoral broach and stem insertion path for this approach is best described as a curved one, rather than the typical straight path. Some femoral components appear to be more suitable to this technique due to their geometries. The purpose of the study was to describe the effects that the single geometric parameter, stem length, has on its insertion path into the femoral canal. Due to the potential introduction of human error associated with repetitively performing a specific motion, both a physical study and a computer generated analysis were conducted.

For the physical portion of the study, a femoral implant body of generic fit and fill geometry was designed and manufactured. The length of the stem was varied from 40 mm to 100 mm in 10 mm increments. A medium sized synthetic femur (Sawbones, Pacific Labs, Seattle, WA) was machined to match the volume of the full length stem. The insertion path constraints were defined such that the stem had to maintain the greatest allowable insertion angle while still making contact on both the medial and lateral side of the canal during translation in the X direction. To reduce the variability in applying the constraints, a single author conducted the insertion procedure for each length stem while the path was videotaped from a fixed position directly in front of the setup. The most proximal lateral point of the stem was tracked through the insertion path and the X, Y coordinates were recorded at a frequency of 2 FPS. The area under this curve, referred to as the minimum insertion area (MIA), was calculated.

For the computer generated portion of the study, a CAD model of the standard length Omnifit^® (Stryker Orthopaedics) was utilized. The stem was modified to create 5 additional models where the length was progressively shortened to 65%, 55%, 45%, 35%, and 25% of original length or 91mm, 77mm, 63mm, 49mm, and 35mm respectively. The femur was created from a solidified mesh of a computed tomography (CT) scan with the canal virtually broached for a full length stem. The models were each virtually assembled within the femoral canal with the similar constraints as the physical study. Again, the most proximal lateral point of the stem was tracked through the insertion path with the coordinates recorded and the MIA was calculated.

There was a non-linear relationship between stem length and the MIA with the rate of change decreasing as the stem length decreased. That is, the greatest decrease in MIA was between the standard length and next longest length in the computer simulation. It was noted that marked change in MIA began to subside between the 77mm and 63mm stems and continued this trend of having less influence onward through to the shorter lengths. Although the results of the physical study showed a higher variability than the computer generated portion, it does confirm the results of the computer generated study.

Minimizing the trauma associated with THR has led most of the above authors to the direct anterior approach. However, the femoral broach and stem insertion path is best described as a curved one, rather than the typical straight path used in other approaches. This curved insertion path also has benefits for other approaches since the broaches and stem can be kept away from the abductors, minimizing the potential injury to them. Shorter stem length makes this curved insertion path easier to perform. This is the first study to describe the effect that stem length has on its insertion path into the femoral canal. As expected, the physical portion of the study showed more variability than the computer generated portion. However, the physical and computer studies correlated well, with shorter stem lengths clearly allowing a more curved insertion path. The improvement tapered off in stem lengths below 63mm. This length correlates well with the other attempts at a shorter stem. This study provides quantitative data to help with shorter stem design and possible computer navigated insertion paths.

Introduction: Clinical experience has shown that addressing variations in bone morphology is important in the development of successful hip implant designs. Numerous studies of femoral bone morphology have been published utilizing various techniques. This study has developed a method which consistently measures large quantities of 3-dimensional digital femura geometry segmented from computed tomography (CT) scans and can accurately make anatomical measurements from these images

Methods: CT images of left femora on five hundred fifty six left femura (57% male, 43% female), consisting of 69% Caucasian, 16% Asian and 14% unknown were analyzed. The average age was 66 years, ranging from 40 to 93 years. Segmentation of the outer cortical, inner cortical, and marrow boundaries were consistently performed over all CT scans. The positions identified on the reference bone are transformed to the equivalent position on the clinical bone images, from which the dimensional data is extracted and stored. The mediolateral width (MLW), medial offset (MO) and lateral offset (LO) were measured in 10mm increments, ranging from 20mm above the lesser trochanter (LT) to 130mm below the lesser trochanter. The canal flare index was defined as a ratio of the mediolateral width at a section 20mm above the lesser trochanter to the mediolateral width at the isthmus level.

Results: The mean mediolateral width at 20mm above the lesser trochanter was 47.0 ± 4.5 (35.1–61.8; n=556). Noble reported 45.4 ± 5.3 (31.0–60.0; n=200), Husmann reported in a neck oriented study 46.3 ± 6.9 (27.6–63.6; n=310) and Laine reported 47.1 ± 4.9 (n=50). The mean medial offset at a section 20mm above the lesser trochanter was 25.1 ± 2.9 (16.7–33.4). In the study by Husmann, a mean of 25.0 ± 5.2 (9.4–45.5) was reported. The mean canal flare index was 4.49 ±.8. Noble reported a mean canal flare index of 3.80 ±.074, Husmann 3.81 ±.83 and Laine 4.3 ±.93.

Discussion: In general, the study showed minor differences to published data of proximal bone morphology. However, this more powerful study has shown that there is a higher mean canal flare index than determined by Noble and a similar mean canal flare index as determined by Laine. As reported by Laine, the canal flare index varies significantly with the placement of measurements in the canal. In this study the measurements were performed in a plane oriented by the femoral neck as a hip stem would be placed. The CFI over the isthmus width showed a greater correlation than previously shown by Noble. The novel software tool allows for anatomical measurements that can be applied to an unlimited population size enabling further applications and studies.