Clinical Study on the Efficacy and Safety of Z101101 in Total Hip Arthroplasty

UMIN ID: UMIN000004797

Registered date:14/01/2011

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients who have been judged to require THA
• Date of first enrollment: 2011/01/01
• Target sample size: 69
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Implantation of components by THA

Outcome(s)

• Primary Outcome: 1) Improvement ratings: Evaluated based on changes in JOA scores at 6 months post-THA from baseline (before THA) according to the criteria . 2) Safety ratings : Evaluated based on details of failures/device-related adverse events (including revision cases) reported during 6 months post-THA according to the criteria.
• Secondary Outcome: Evaluations at 6 months post-THA 1) Safety ratings. 2) Morphological stability. 3) Improvements in JOA scores and SF-12 (QOL) questionnaire scores. Evaluations at 2 years of follow-up 1) Failures/adverse events. 2) Morphological stability. 3) Improvements in JOA scores and SF-12 (QOL) questionnaire scores.

Key inclusion & exclusion criteria

• Age minimum: 21years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) The patient is a known alcohol or drug abuser. 2) The patient has a neuromuscular disorder, vascular disorder or other condition that could cause implant instability, implant fixation failure, or postoperative complications. 3) The patient has a vascular insufficiency (large and small vessel disease), renal impairment, or renal failure. 4) The patient has initiated a chronic administration of systemic or inhaled steroid within 3 months. 5) The patient has a neurologic condition that could affect the function of the lower limbs. 6) The patient needs to be corrected a leg length discrepancy >= 3.2 cm. 7) The patient has a systemic disease that could affect his/her safety or the study outcome. 8) The patient has a contagious disease and is difficult to continue observation/investigation. 9) The patient is known to be pregnant. 10) The patient has received an investigational drug or other investigational device within the previous 6 months. 11) The patient has an active or latent infection in or about the affected hip joint or an infection distant from the affected hip joint that may spread to the affected joint hematogenously. 12) The patient has a known sensitivity or allergic reaction to any of the materials of the joint prosthesis including metal and ceramic. 13) The patient has an acute fracture in the affected femoral head that requires THA. 14) The patient has undergone THA, revision surgery or surface arthroplasty of the contralateral hip within the previous 6 months. 15) The patient has had previous girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated. 16) The patient has insufficient bone stock to fix the hip prostheses. 17) The patient has a local bone tumor or cyst in the affected hip joint. 18) The patient has a Body Mass Index (BMI) >35.

Related Information

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