This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.
A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner. All potential study subjects will be required to participate in the Informed Consent process.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
Bravis
Roosendaal, Netherlands
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)
Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)
Time frame: 2 years postoperatively
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.
Time frame: 2 years postoperatively
Early Survival Assessed by Counting the Number of Implant Revisions
Assessed by counting the number of implant revisions
Time frame: Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)
Time frame: pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
Assess radiographs for signs of stress shielding, radiolucency and stem alignment.
Time frame: 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.
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Time frame: 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome EQ5D
Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health).
Time frame: 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score.
Time frame: pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis. The rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis.
Time frame: 6 weeks, 1 year and 2 years postoperatively