Randomized Controlled Trial
Copyright ©The Author(s) 2020.
World J Orthop. Oct 18, 2020; 11(10): 442-452
Published online Oct 18, 2020. doi: 10.5312/wjo.v11.i10.442
Table 1 Inclusion and exclusion criteria
InclusionExclusion
Primary arthroplasty due to:Patients who recently suffered:
Primary osteoarthritisPost-operative osteoarthritis
Avascular necrosisCharnley C osteoarthritis
Femoral neck fractureInfection of the hip
Hip dysplasia
Age between 60 - 75 yr at surgeryPrior osteotomy or arthroplasty of the affected hip
Willing to comply with the post-operative review programUnder treatment for osteoporosis
Body mass index > 35 kg/m2
Requiring cortisone medication
Table 2 Patient and baseline characteristics
Conventional PEREXPOL
Number of patients, n (%)25 (49)26 (51)
Gender, n (%)
Male10 (40)10 (39)
Female15 (60)16 (59)
BMI, mean ± SD kg/m226.7 ± 2.927.2 ± 3.4
Age at operation in years, mean ± SD68.5 ± 4.668.6 ± 5.1
HOOS pain, mean ± SD46.5 ± 21.651.1 ± 17.7
HOOS ADL, mean ± SD41.1 ± 16.646.0 ± 17.2
HHS, mean ± SD50.6 ± 12.754.6 ± 10.9
Table 3 Total wear in all directions at the five-year follow-up, presented as mean with ranges
Conventional PE (Polyethylene)REXPOLP value
Medial (mm)-0.128 (-0.202 to -0.054)0.013 (-0.054 to 0.081)0.006
Proximal (mm)0.196 (0.054 to 0.338)0.017 (-0.120 to 0.154)0.07
Volume (mm3)113.39 (-2.48 to 229.26)-30.59 (-167.16 to 105.98)0.10
Corrected volume (mm3)121.6 (17.76 to 225.46)-12.45 (-122.94; 98.03)0.07
Table 4 Mean wear rates per year, presented as mean with ranges
Conventional PE (Polyethylene)P valueREXPOLP value
Medial (mm/yr)-0.021 (-0.028 to -0.015)< 0.0010.004 (-0.002 to 0.009)0.21
Proximal (mm/yr)0.033 (0.018 to 0.047)< 0.0010.003 (-0.011 to 0.017)0.66
Volume (mm3/yr)15.94 (2.729 to 29.15)0.02-5.545 (-20.36 to 9.269)0.46
Corrected volume (mm3/yr)18.53 (7.188 to 29.86)0.002-2.142 (-14.13 to 9.841)0.72
Table 5 Functional outcomes at the five-year follow-up, presented as mean with 95%CI
Univariate
Multivariate
Conventional PE (n = 17)REXPOL (n = 17)P valueAdjusted β-coefficientP value
HOOS pain93.8 (86.8; 100)85.9 (77.1; 94.7)0.15-3.3 (-14.9; 8.3)0.57
HOOS ADL89.0 (81.2: 96.8)77.6 (66.6; 88.5)0.08-8.6 (-23.3; 6.1)0.24
HHS89.7 (83.0; 96.4)86.5 (78.8; 94.2)0.510.15 (-10.1; 10.4)0.98