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Randomized study using the BICON-PLUS cup with a modified surface treatment

Randomized study using the BICON-PLUS cup with a modified surface treatment - RCT Bicon-Plus NT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30509
Enrollment
50
Registered
2007-02-28
Start date
2007-03-31
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Coxarthrosis wear of the hip joint

Interventions

- Total hip arthroplasty using a standard cup (Bicon-Plus) - Total hip arthroplasty using a cup with a modified surface (Bicon-Plus NT)

Sponsors

PLUS Endoprothetik AG
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with primary or secondary osteoarthrosis - Patients requiring primary arthroplasty - Age at time of surgery: 50-70 years

Exclusion criteria

Exclusion criteria: - Patients with rheumatoid arthritis - Patients whose body mass index is higher than 35 - Patients requiring revision arthroplasty

Design outcomes

Primary

MeasureTime frame
Postoperative bone minderal density (BMD)

Secondary

MeasureTime frame
- WOMAC (Western Ontario and McMaster Universities) - Harris Hip Score - Radiology: prevalence of radiolucent lines

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)