A prospective, multicenter, non-randomized, clinical outcome study of the R3 acetabular System in patients with degenerative hip disease.

Phase 4

Completed

• Conditions: reumatoid arthritis; 10023213; 10005944; osteoarthritis

• Registration Number: NL-OMON47358
• Lead Sponsor: Smith & Nephew Orthopedics AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

* Patient requires primary total hip arthroplasty due to non-inflammatory
degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., rheumatoid arthritis)
* Patient has met an acceptable preoperative medical clearance and is free from
or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
* The patient is willing to comply the follow-up schedule
Patient is 18-75 years old and he/she is skeletally mature

Exclusion Criteria

* Patient has active infection or sepsis (treated or untreated)
* Patient is a prisoner or has an emotional or neurological condition that would
pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse.
* Patients with acute hip trauma (femoral neck fracture)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Survival rate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Harris Hip Score,<br /><br>HOOS,<br /><br>UCLA,<br /><br>radiologic findings.</p><br>