Multi-Centre Study to Assess the Long-Term Safety and Efficacy of the Silent™ Hip Prosthesis in Primary Total Hip Replacement

Inclusion Criteria:

i) Male or female subjects, aged 18 years or above at the point of screening for participation.

ii) Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-treatment follow-ups.

iv) Subjects with non-inflammatory osteoarthritis of the hip who require a primary total hip replacement and are considered suitable for a cementless femoral and acetabular component.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 months. This exclusion does not apply to those subjects who are participating in the pilot investigation of the DePuy Silent Hip (CT01/27)

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects who have osteonecrosis of the femoral neck

vii) Subjects with significant bone loss or gross deformity in the region of the neck of the femur as identified on the pre-operative radiographs, where in the Investigator's opinion, there could be considerable migration of the DePuy Silent Hip or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the DePuy Silent Hip.

viii) Subjects with a Charnley C classification.

ix) Subjects with an active local or systemic infection.

x) Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the arthroplasty procedure unjustified.

xi) Subjects with Paget's disease