A Clinical Study on the Dislocation and Wear of Highly Crosslinked Polyethylene Liner

UMIN ID: UMIN000005316

Registered date:25/03/2011

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Osteoarthritis of the Hip, Avascular Necrosis of the Femoral Head
• Date of first enrollment: 2002/04/01
• Target sample size: 240
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The mean annual wear of the polyethylene liner and the incidences of dislocation
• Secondary Outcome: X-ray findings, Harris Hip Score, JOA Score and QOL

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: - Patients with osteomyelitis of the upper femoral bone - Patients with active infection at the affected joint - Patients with extremely insufficient bone mass - Patients who have already undergone hip replacement arthroplasty - Patients with the socket outer diameter of less than 48 mm - Other patients who are judged to be ineligible to participate in the study by the surgeon

Related Information

• Primary Sponsor: Zimmer Biomet G.K.
• Source(s) of Monetary Support: Zimmer Biomet G.K.