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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteo introducer group | Experimental | undergo minimal invasive total hip arthroplasty surgery |
|
| Control group | Active Comparator | undergo common total hip arthroplasty surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimum invasive total hip arthroplasty | Procedure | Minimum invasive total hip arthroplasty using the osteo introducer system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation the restoration of hip function at 3 month | Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of X-ray | Assessment of position, confirm whether there is loosening, dislocation or fracture etc. | 1day, 6 week, 6 month |
| Evaluation the restoration of hip function at each time frame |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| Common total hip arthroplasty | Procedure | Common total hip arthroplasty using common instruments |
|
Assessment the Harris Hip Score at each time frame
| 6 week, 3 month, 6 month |
| Barthel Index | Assessment the daily living activity | 1day, 3day, 2 week, 6 week, 3 month, 6 month |
| Berg Balance Scale | Assessment the balance ability | 1day, 3day, 2 week, 6 week, 3 month, 6 month |
| Visual Analogue Scale | Assessment the degree of pain | 1day, 3day, 2 week |
| The use of analgesics | Investigate the name and dosage of analgesics to indirectly assess the degree of pain | 1day, 3day, 2 week, 6 week, 3 month, 6 month |
| Adverse events | Investigate all the adverse events happened during the study period | up to 6 month |
| Laboratory Examinations | Collect the following laboratory results which reflect the traumatic stress:Glu, CRP, Alb, CK, TBA, UA, Ca, Mg, WBC, GRA | 3 day, 6 week |
| Dislocation rate | Compare the dislocation rate | 1day, 3day, 2 week, 6 week, 3 month, 6 month |