The effect of large diameter head to prevent dislocation, and of 3 rd generation highly crosslinked polyethylene to reduce wear in computer assisted total hip arthroplasty

The effect of large diameter head to prevent dislocation, and of 3 rd generation highly crosslinked polyethylene to reduce wear in computer assisted total hip arthroplasty - Navi & X3 Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000004154

Enrollment

120

Registered

2010-09-03

Start date

2010-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

OA, AVN, RA, Fracture, and etc.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients are candidate for a primary THA with cementless acetabular and femoral components. 2. Patients have diagnosis of degenerative joint disease. 3. Patients are age 20 or over. 4. Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form. 5. Patients are willing and able to comply with postoperative scheduled evaluations.

Exclusion criteria

Exclusion criteria: 1. Patients have bacterial infectious disease or have risk highly of bacterial infection. 2. Patients requiring revision surgery of a previously implanted total hip arthroplasty. 3. Patients, who are morbidly obese, defined as having a Body Mass Index (BMI) > 40. 4. Patients who is pregnant female or maybe so. 5. Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. 6. Patients with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy). 7. Patients who are immunologically suppressed or receiving chronic steroids. 8. Patients who are judged ineligible with reasonable reason by primary doctor.

Design outcomes

Primary

Measure	Time frame
1. Range of motion 2. Interannual behavior of wear	—

Countries

Japan

Contacts

Public ContactYuko Komori

Stryker Japan K.K. Clinical Affairs

stryker_japan-com@umin.ac.jp03-6894-8322

Outcome results