Osteo introducer system is the instruments used in minimal invasive THA. This study will compare the minimal invasive THA using the osteo introducer system and THA using common instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of THA surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Minimum invasive total hip arthroplasty using the osteo introducer system
Common total hip arthroplasty using common instruments
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Evaluation the restoration of hip function at 3 month
Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative
Time frame: 3 month
Evaluation of X-ray
Assessment of position, confirm whether there is loosening, dislocation or fracture etc.
Time frame: 1day, 6 week, 6 month
Evaluation the restoration of hip function at each time frame
Assessment the Harris Hip Score at each time frame
Time frame: 6 week, 3 month, 6 month
Barthel Index
Assessment the daily living activity
Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Berg Balance Scale
Assessment the balance ability
Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Visual Analogue Scale
Assessment the degree of pain
Time frame: 1day, 3day, 2 week
The use of analgesics
Investigate the name and dosage of analgesics to indirectly assess the degree of pain
Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Adverse events
Investigate all the adverse events happened during the study period
Time frame: up to 6 month
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Laboratory Examinations
Collect the following laboratory results which reflect the traumatic stress:Glu, CRP, Alb, CK, TBA, UA, Ca, Mg, WBC, GRA
Time frame: 3 day, 6 week
Dislocation rate
Compare the dislocation rate
Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month