Prospective, single centre, randomized clinical study; series of patients with a 5-years patient evaluation period.
This is a single centre randomized clinical outcomes study. The Symax stem or Accolade TMZF (Titan, Molybdenum, Zirconium, Ferrum) in combination with the Hemispherical Trident cup, X3 inserts, 28 and 40 mm Metal heads are the primary components to be implanted for evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Atrium Medical Center
Heerlen, Netherlands
To Compare Wear of the Polyethylene X3 Insert Based on Digital Radiographs Using the Hip Analysis Suite (HAS).
Determine equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes using HAS, a software for the determination of polyethylene wear on digital radiographs.
Time frame: 5 years follow-up
Harris Hip Score (HHS) Patient Questionnaire
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor.
Time frame: 6 weeks, 3 months, 1, 2 and 5 years
Merle D'Aubergine Score (MdA)
The Merle D'Aubergine-Charnley Score is a simplified clinical scoring system for the hip. The overall score is determined by the sum of scores obtained from each dimension of pain, walking ability and joint mobility. The overall numeric score is given by adding the domain scores. Clinical grades: Excellent, 18, Good 15-17, Fair 13-14, Poor \<13.
Time frame: 6 weeks, 3 months, 1, 2 and 5 years
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Orthopaedic implant