partial knee replacement as a definitive implant: 20 year ...opkr designs, using roentgen...

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Partial Knee Replacement as a Definitive Implant: 20 year in-vivo wear results. + 1 Simpson, D J; 1 Kendrick, B K; 1 Gill, H S; 2 Valstar, E; 2 Kaptein, B; 3 Dodd, C; 1,3 Murray, D W; 1,3 Price, A P + 1 University of Oxford, Oxford, UK, 2 Leiden University Medical Centre, Leiden, the Netherlands 3 Nuffield Orthopaedic Centre, Oxford, UK [email protected] INTRODUCTION: Polyethylene wear in joint arthroplasty has long been held as one of the major causes of aseptic loosening, in addition to revision of catastrophically worn bearings. The Phase 1 Oxford partial knee replacement (OPKR) (Figure 1) was introduced as a design against wear, with a fully congruous articulation. In 1987 the Phase 2 implant was introduced with new instrumentation and changes to the bearing shape to reduce the incidence of anterior impingement; a spherical mill was introduced for the femoral side and the anterior lip of the bearing was reduced in height. We have previously shown that the implant has a wear rate of 0.02 mm/year at ten years, in well functioning devices, but that higher wear rates can be seen with impingement or if the congruous articulation is lost. The aim of this study was to investigate whether there is a difference in wear at 20 years between the Phase 1 and Phase 2 OPKR designs, using Roentgen Stereophotogrammetric Analysis (RSA). METHODS: We measured the in-vivo wear of 7 Phase 1 (5 patients, mean age 65.24 years) and 7 Phase 2 (4 patients, mean age at operation 63.43) Oxford PKR bearings. Average time since surgery was 22.37 years and 19.46 years for the Phase 1 and Phase 2 implants respectively. Selection criteria included patients who were mobile, with an exercise tolerance greater than 100m as per the American Knee Society functional questionnaire. RSA x-rays were taken with the knee in the normal anatomical position on standing and with the knee flexed to 30°. Wear was calculated using an RSA CAD model system, to fit silhouettes of the prostheses to the biplanar images. The RSA software (Medis Specials, Leiden, Netherlands) estimated the pose of both the femoral and tibial components. For a control the bearings of ten knees receiving PKRs were measured using this system within one week of their operation. This provided a measure of the system accuracy as it is assumed that no wear has occurred in the first week. The Oxford Knee and American Knee Society Scores were obtained when patients attended for their radiographs. A sphere was fit to the femoral component and the bearing thickness was determined by measuring the shortest perpendicular distance between the two components. The linear wear for each bearing was calculated by subtracting the measured thickness from the corrected nominal bearing thickness. Figure 1. Phase 1 Oxford PKR (A&C), showing different interior geometry of the femoral component compared with phase 2 (B&D). RESULTS: The demographics for each of the patients are shown in Table 1. There was no statistically significant difference in patient age but there was a significant difference for time since surgery. There was also no statistically significant difference for the Oxford Knee Score, the total American Knee Society Score, or the functional section of the AKSS. The measured wear rate was 0.072 mm/year for Phase 1 (S.D. 0.028, range: 0.031 – 0.104 mm) and 0.028 mm/year for Phase 2 (S.D. 0.019, range: 0.014 – 0.07 mm). This difference in wear rate for the two phases was statistically significant (p = 0.0028). The bearings of the ten control knees measured postoperatively showed a mean difference of 0.02 mm between the measured thickness and the nominal bearing thickness, with a standard deviation of 0.09 mm. Age at Surgery Years since surgery OKS AKSS AKSS Function AKSS Total Phase 1 mean 65.24 22.37 40.71 97.71 70.71 167.71 Phase 2 mean 63.43 19.46 39.86 89.43 70.71 160.14 p-value (t-test) 0.56 0.002 0.694 0.016 1.00 0.321 Table 1 – Patient demographics and functional scores. Phase Phase 2 Phase 1 Wear (mm/year) 0.12 0.10 0.08 0.06 0.04 0.02 0.00 n=7 n=7 Figure 2. Boxplot for each phase. Solid black line is the median, the height of the box is the interquartile range and the whiskers are the range of results. DISCUSSION: The results show that in the knees studied there was a significant difference between wear rates in Phase 1 and 2. We propose that these differences are explained by impingement in Phase 1, which was reduced by design changes with the introduction of Phase 2. The instrumentation for Phase 2 included a mill for the femoral component, which enables more accurate placement of the femoral component and better ligament balancing. The Phase 2 OPKR is thus designed to avoid impingement between the femur and the bearing. This study demonstrates that very low wear rates can be maintained with the Phase 2 implant to the end of the second decade after implantation and that low wear designs need appropriate methods of implantation. This is of particular importance when a device is used in younger patients, and demonstrates that the OPKR can, in some patients, be a definitive implant and not an interim to total knee replacement. Paper No. 169 56th Annual Meeting of the Orthopaedic Research Society

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  • Partial Knee Replacement as a Definitive Implant: 20 year in-vivo wear results.

    +1Simpson, D J; 1Kendrick, B K; 1Gill, H S; 2Valstar, E; 2Kaptein, B; 3Dodd, C; 1,3Murray, D W; 1,3Price, A P

    +1University of Oxford, Oxford, UK, 2Leiden University Medical Centre, Leiden, the Netherlands 3Nuffield Orthopaedic Centre, Oxford, UK

    [email protected]

    INTRODUCTION:

    Polyethylene wear in joint arthroplasty has long been held as one of

    the major causes of aseptic loosening, in addition to revision of

    catastrophically worn bearings. The Phase 1 Oxford partial knee

    replacement (OPKR) (Figure 1) was introduced as a design against wear,

    with a fully congruous articulation. In 1987 the Phase 2 implant was

    introduced with new instrumentation and changes to the bearing shape to

    reduce the incidence of anterior impingement; a spherical mill was

    introduced for the femoral side and the anterior lip of the bearing was

    reduced in height. We have previously shown that the implant has a

    wear rate of 0.02 mm/year at ten years, in well functioning devices, but

    that higher wear rates can be seen with impingement or if the congruous

    articulation is lost. The aim of this study was to investigate whether

    there is a difference in wear at 20 years between the Phase 1 and Phase 2

    OPKR designs, using Roentgen Stereophotogrammetric Analysis (RSA).

    METHODS:

    We measured the in-vivo wear of 7 Phase 1 (5 patients, mean age

    65.24 years) and 7 Phase 2 (4 patients, mean age at operation 63.43)

    Oxford PKR bearings. Average time since surgery was 22.37 years and

    19.46 years for the Phase 1 and Phase 2 implants respectively. Selection

    criteria included patients who were mobile, with an exercise tolerance

    greater than 100m as per the American Knee Society functional

    questionnaire. RSA x-rays were taken with the knee in the normal

    anatomical position on standing and with the knee flexed to 30°. Wear

    was calculated using an RSA CAD model system, to fit silhouettes of

    the prostheses to the biplanar images. The RSA software (Medis

    Specials, Leiden, Netherlands) estimated the pose of both the femoral

    and tibial components. For a control the bearings of ten knees receiving

    PKRs were measured using this system within one week of their

    operation. This provided a measure of the system accuracy as it is

    assumed that no wear has occurred in the first week. The Oxford Knee

    and American Knee Society Scores were obtained when patients

    attended for their radiographs.

    A sphere was fit to the femoral component and the bearing thickness

    was determined by measuring the shortest perpendicular distance

    between the two components. The linear wear for each bearing was

    calculated by subtracting the measured thickness from the corrected

    nominal bearing thickness.

    Figure 1. Phase 1 Oxford PKR (A&C), showing different interior

    geometry of the femoral component compared with phase 2 (B&D).

    RESULTS:

    The demographics for each of the patients are shown in Table 1.

    There was no statistically significant difference in patient age but there

    was a significant difference for time since surgery. There was also no

    statistically significant difference for the Oxford Knee Score, the total

    American Knee Society Score, or the functional section of the AKSS.

    The measured wear rate was 0.072 mm/year for Phase 1 (S.D. 0.028,

    range: 0.031 – 0.104 mm) and 0.028 mm/year for Phase 2 (S.D. 0.019,

    range: 0.014 – 0.07 mm). This difference in wear rate for the two phases

    was statistically significant (p = 0.0028).

    The bearings of the ten control knees measured postoperatively showed

    a mean difference of 0.02 mm between the measured thickness and the

    nominal bearing thickness, with a standard deviation of 0.09 mm.

    Age at

    Surgery

    Years

    since

    surgery OKS AKSS

    AKSS

    Function

    AKSS

    Total

    Phase 1 mean 65.24 22.37 40.71 97.71 70.71 167.71

    Phase 2 mean 63.43 19.46 39.86 89.43 70.71 160.14

    p-value (t-test) 0.56 0.002 0.694 0.016 1.00 0.321

    Table 1 – Patient demographics and functional scores.

    Phase

    Phase 2Phase 1

    We

    ar (

    mm

    /year)

    0.12

    0.10

    0.08

    0.06

    0.04

    0.02

    0.00

    n=7 n=7

    Figure 2. Boxplot for each phase. Solid black line is the median, the

    height of the box is the interquartile range and the whiskers are the range

    of results.

    DISCUSSION:

    The results show that in the knees studied there was a significant

    difference between wear rates in Phase 1 and 2. We propose that these

    differences are explained by impingement in Phase 1, which was

    reduced by design changes with the introduction of Phase 2. The

    instrumentation for Phase 2 included a mill for the femoral component,

    which enables more accurate placement of the femoral component and

    better ligament balancing. The Phase 2 OPKR is thus designed to avoid

    impingement between the femur and the bearing. This study

    demonstrates that very low wear rates can be maintained with the Phase

    2 implant to the end of the second decade after implantation and that low

    wear designs need appropriate methods of implantation. This is of

    particular importance when a device is used in younger patients, and

    demonstrates that the OPKR can, in some patients, be a definitive

    implant and not an interim to total knee replacement.

    Paper No. 169 • 56th Annual Meeting of the Orthopaedic Research Society