Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty: A Prospective, Multicenter, Randomized Controlled Study

Conditions
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Joint Disease

Intervention / Treatment
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* Procedure: Minimum invasive total hip arthroplasty
* Procedure: Common total hip arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With indications of total hip arthroplasty (e.g. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis; rheumatoid arthritis; correction of functional deformity, etc.) BMI<30 Subject is a candidate for primary total hip arthroplasty No obvious congenital abnormality in hip joint Subject has no mental illness, is willing to join the study voluntarily and sign the approved informed consent document; is willing and able to complete required study visits or assessments Exclusion Criteria: Subjects with inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable Overt infection Distant foci of infections Allergy to metals Rapid disease progression as manifested by joint destruction or bone absorption apparent on X-ray Skeletally immature Neuropathic joints Hepatitis or HIV infection Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing Pregnant or lactating women Subjects enrolled in another drug or device clinical investigation within 3 month Investigator has judged the subject is not suitable for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteo introducer group<br>undergo minimal invasive total hip arthroplasty surgery | Procedure: Minimum invasive total hip arthroplasty<br>* Minimum invasive total hip arthroplasty using the osteo introducer system<br>|
| Active Comparator: Control group<br>undergo common total hip arthroplasty surgery | Procedure: Common total hip arthroplasty<br>* Common total hip arthroplasty using common instruments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, minimal invasive