Assessing the safety and performance of a hip resurfacing prosthesis compared with a conventional total hip prosthesis in relatively young males with primary arthritis; a prospective, controlled clinical study.

Assessing the safety and performance of a hip resurfacing prosthesis compared with a conventional total hip prosthesis in relatively young males with primary arthritis; a prospective, controlled clinical study. - BHR2014 study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41141

Enrollment

200

Registered

2014-12-19

Start date

2015-03-09

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Arthritis of the hip coxarthrosis osteoarthitis

Interventions

The selected patient group in this study is already qualfied for a hip replacement. The intervention in this trail is the implantation of the BHR resrurfacing implant instead of the standard total

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Male patients between 18 and 60 years of age 2.Patients requiring primary hip replacement 3.Patients with an endstage of primary arthritis of the hip 4.Patients with a femoral head * 50 mm (as measured by calibrated X-ray imaging)

Exclusion criteria

Exclusion criteria: 1.Patients with a BMI >35 2.Patients with infection or sepsis 3.Patients with bone stock inadequate to support the device including: a.Patients with severe osteopenia or with a family history of severe osteoporosis or severe osteopenia b.Patients with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT grade) c.Patients with multiple cysts of the femoral head (> 1cm) 4.Patients with known moderate to severe renal insufficiency 5.Patients who are immunologically suppressed with diseases such as AIDS, or patients who are receiving corticosteroids in high doses 6.Patients with known or suspected metal sensitivity 7.Patients who are skeletally immature 8.Patients with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery 9. Patients suffering from diabetes type I or II

Design outcomes

Primary

Measure	Time frame
- UCLA activity score - Incidence of device related adverse events.	—

Secondary

Measure	Time frame
- Evaluation of overall survival of the BHR - Evaluation of quality of life, as assessed by the EQ-5D score, the Harris Hip Score (HHS) and the Hip disability and - Osteoarthritis Outcome Score (HOOS) over time - Evaluation of cobalt blood concentrations over time - Evaluation of the acetabular component positioning by X-ray	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)