Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components (TOPAZ)

MicroPort

Status

Withdrawn

Conditions

Osteoarthritis

Joint Disease

Treatments

Device: PROFEMUR Preserve Classic Femoral Components

Study type

Interventional

Funder types

Industry

Identifiers

NCT02668211

14LJH002

Details and patient eligibility

About

MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.

Sex

All

Ages

21 to 76 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is a candidate for primary THA for osteoarthritis
Subject is able to undergo primary THA procedure
Subject is a candidate to be implanted with the specified combination of components
Subject is willing and able to complete required study visits and assessments
Subject is willing to sign the approved Informed Consent document

Exclusion criteria

Subject has any of the following contraindications at the time of the implantation:
Overt infection;
Distant foci of infections (which may cause hematogenous spread to the implant site);
Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram;
Skeletally immature (less than 21 years of age at time of surgery);
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;
Subjects 76 years of age or older
Subjects with post-traumatic arthritis in the affected hip
Subjects with rheumatoid arthritis in the affected hip
Subjects with hip dysplasia in the affected hip
Subjects with prior arthroplasty of the affected hip
Subjects that are morbidly obese (BMI > 35)
Subjects that are immuno-suppressed
Subjects with known or tested-positive allergy to metals
Subjects currently enrolled in another clinical investigation which could affect the endpoints of this protocol
Subjects unwilling or unable to sign the Informed Consent document
Subjects with substance abuse issues
Subjects who are incarcerated or have pending incarceration