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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47358
Enrollment
50
Registered
2009-09-17
Start date
2009-11-02
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis reumatoid arthritis

Interventions

None listed

Sponsors

Smith & Nephew Orthopedics AG
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Survival rate.

Secondary

MeasureTime frame
Harris Hip Score, HOOS, UCLA, radiologic findings.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)