Unique ID issued by UMIN | UMIN000047608 |
---|---|
Receipt number | R000054287 |
Scientific Title | Randomized controlled study comparing Augmented Reality (AR) Hip Navigation System versus conventional instrumentation |
Date of disclosure of the study information | 2022/05/01 |
Last modified on | 2022/12/09 13:12:16 |
Randomized controlled study comparing Augmented Reality (AR) Hip Navigation System versus conventional instrumentation on THA in Lateral Decubitus position
AR Hip RCT on THA in lateral decubitus position
Randomized controlled study comparing Augmented Reality (AR) Hip Navigation System versus conventional instrumentation
AR Hip RCT on THA in lateral decubitus position
Japan |
Hip Arthroplasty
Orthopedics |
Others
NO
To evaluate the accuracy of AR Hip by comparing the difference between the target placement angle and the postoperative placement angle between the AR Hip group and the conventional group.
Efficacy
Confirmatory
Not applicable
The difference between the target placement angle and the postoperative placement angle between the AR Hip group and the conventional group.
The influence of surgery time / Incidence of adverse event after THA / Harris Hip Score and JHEQ degree of improvement / Acetabular Cup alignment accuracy
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is considered as a block.
YES
Numbered container method
2
Treatment
Device,equipment |
G7 acetabular system THA with AR Hip System as the Control group
G7 acetabular system THA without AR Hip System as the Control group
20 | years-old | <= |
80 | years-old | >= |
Male and Female
- 20 to 80 years of age, inclusive
- Skeletally mature
- Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
- Type 1 or Type2 of Crowe classification
- Willing and able to complete scheduled follow-up evaluations as described in the study protocol
- Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent
- Has an anteversion of 20 degrees or more at the target placement angle
- Has an excessive flexion contracture
- Has an asymmetric pelvis
- Has a history of hip surgery on the affected side
- Judged as inappropriate subject by surgeons performing regenerative medicine
100
1st name | Hiroyuki / Naoyuki |
Middle name | |
Last name | Ogawa / Hirasawa |
Hokusuikai Kinen Hospital
Orthopedic
310-0035
3-2-1 Higashihara, Mito-shi, Ibaraki 310-0035, Japan
029-303-3003
wscww899@yahoo.co.jp
1st name | Yukako |
Middle name | |
Last name | Shiraishi |
Zimmer Biomet G.K.
Clinical Affairs
105-0011
11-1 Shibakoen 2-chome, Minato-ku, Tokyo 105-0011, Japan
03-6402-6600
yukako.shiraishi@zimmerbiomet.com
Hokusuikai Kinen Hospital
None
Self funding
Hokusuikai Kinen Hospital IRB
3-2-1 Higashihara, Mito-shi, Ibaraki 310-0035, Japan
029-303-3003
yukako.shiraishi@zimmerbiomet.com
NO
土浦協同病院(茨城県)、聖マリアンナ医科大学病院(神奈川県)、市立甲府病院(山梨県)、同愛記念病院(東京都)、新渡戸記念中野総合病院(東京都)
2022 | Year | 05 | Month | 01 | Day |
Unpublished
Open public recruiting
2022 | Year | 04 | Month | 13 | Day |
2022 | Year | 04 | Month | 21 | Day |
2022 | Year | 06 | Month | 10 | Day |
2024 | Year | 12 | Month | 31 | Day |
2022 | Year | 04 | Month | 27 | Day |
2022 | Year | 12 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054287
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