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Large head metal-on-metal cementless total hip arthroplasty versus 28mm metal-on-polyethylene cementless total hip arthroplasty, a prospective randomized controlled trial

Large head metal-on-metal cementless total hip arthroplasty versus 28mm metal-on-polyethylene cementless total hip arthroplasty, a prospective randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22044
Enrollment
100
Registered
2008-08-08
Start date
2006-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

osteoarthritis, hip, coxartrose, total hip arthroplasty, totale heup prothese, metal-on-metal, metal-on-polyethylene, DEXA, cobalt chromium ions

Interventions

Patients in the metal-on-metal group will receive a total hip arthroplasty consisting of a cementless titanium alloy acetabular component with a cobalt-chromium liner (M2a-Magnum™, Biomet) and a cobal

Sponsors

Department of Orthopaedic Surgery, Martini Hospital, Groningen, the Netherlands; Departments of Orthopaedic Surgery and Biomedical Engineering, University Medical Center Groningen, University of Groningen, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 18 and 80 with non-inflammatory degenerative joint disease of the hip including osteoarthritis, avascular necrosis and traumatic arthritis, admitted for cementless total hip arthroplasty.

Exclusion criteria

Exclusion criteria: 1. Active infection 2. Revision arthroplasty 3. Marked bone loss precluding adequate fixation 4. Unwillingness of inability to follow instruction.

Design outcomes

Primary

MeasureTime frame
- Bone mass density loss and serum metal ion concentrations.

Secondary

MeasureTime frame
- Functional scores - Range of motion - Number of dislocations - Radiographic evaluation - Survival; - Systemic cytokine levels (in progress)

Contacts

Public ContactW.P. Zijlstra

Martini Hospital Department of Orthopaedic Surgery PO Box 30.033

ZijlstWP@mzh.nl+31 (0)50 5245970

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)