Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

Suzhou MicroPort OrthoRecon

Status

Completed

Conditions

Joint Disease

Treatments

Procedure: Common total hip arthroplasty

Procedure: Minimum invasive total hip arthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT03113591

MP-GJ15-01

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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