Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity

Ghent University Hospital (UZ)

Status: Completed

Conditions: Hip Osteoarthritis

Treatments: Device: metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT00285974

2003/398

Details and patient eligibility

About

Prospective study including 6 groups of 20 patients with a total hip prosthesis. Five different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic prostheses acts as control group. Patients undergo a clinical evaluation and blood sampling preoperatively, and 3, 6, 12 and 24 months postoperatively.

Enrollment: 120 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hip osteoarthritis

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

hip prosthesis

Experimental group

Treatment:

Device: metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis