Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

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

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.

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