Unique ID issued by UMIN | UMIN000004154 |
---|---|
Receipt number | R000004937 |
Scientific Title | 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 |
Date of disclosure of the study information | 2010/09/03 |
Last modified on | 2017/09/07 16:02:15 |
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
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
Japan |
OA, AVN, RA, Fracture, and etc.
Orthopedics |
Others
NO
1. To prove the efficacy of large diameter head in computer assisted total hip arthroplasty.
2. To prove the superiority of X3 acetabular liner on wear resistance.
Safety,Efficacy
1. Range of motion
2. Interannual behavior of wear
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
120
1st name | |
Middle name | |
Last name | Yuko Komori |
Stryker Japan K.K.
Clinical Affairs
Iidabashi First Tower 30F, 2-6-1, Koraku, Bunkyo-ku, Tokyo
03-6894-8322
stryker_japan-com@umin.ac.jp
1st name | |
Middle name | |
Last name | Yuko Komori |
Stryker Japan K.K.
Clinical Affairs
Iidabashi First Tower 30F
03-6894-8322
stryker_japan-com@umin.ac.jp
Stryker Japan K.K.
Stryker Japan K.K.
Profit organization
Japan
NO
横浜市立大学附属病院(神奈川県)他
2010 | Year | 09 | Month | 03 | Day |
Unpublished
Completed
2010 | Year | 05 | Month | 31 | Day |
2010 | Year | 07 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
1. Analysis of ROM data.
2. Evaluation of wear rate by X-ray analysis.
3. Collection of adverse event (e.g. dislocation)
2010 | Year | 09 | Month | 03 | Day |
2017 | Year | 09 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004937
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |