Unique ID issued by UMIN | UMIN000041378 |
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Receipt number | R000047239 |
Scientific Title | Effect of cementless acetabular component surface processing on initial fixation after total hip arthroplasty with secondary hip osteoarthritis: three-dimensional porous cup versus hydroxyapatite-coating cup |
Date of disclosure of the study information | 2020/08/11 |
Last modified on | 2024/02/12 15:54:32 |
Effect of cementless acetabular component surface processing on initial fixation after total hip arthroplasty with secondary hip osteoarthritis: three-dimensional porous cup versus hydroxyapatite-coating cup
Effect of cementless acetabular component surface processing on initial fixation after total hip arthroplasty
Effect of cementless acetabular component surface processing on initial fixation after total hip arthroplasty with secondary hip osteoarthritis: three-dimensional porous cup versus hydroxyapatite-coating cup
Effect of cementless acetabular component surface processing on initial fixation after total hip arthroplasty
Japan |
Secondary osteoarthritis caused by hip dysplasia or osteonecrosis of the femoral head
Orthopedics |
Others
NO
To examine the sequential bone fixation around 3D-porous cup (SQRUM TT) after total hip arthroplasty in comparison with that around HA-coating cup (SQRUM HA) based on Randomized Controlled Trial.
Efficacy
Confirmatory
Comparison of the sequential bone fixation around cementless acetabular cup between SQRUM TT and SQRUM HA.
To examine the relationship of the sequential bone fixation around cementless acetabular cup with investigation items, including background, clinical assessment, radiograph, and patient-reported outcome.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
YES
Numbered container method
2
Prevention
Device,equipment |
Total hip arthroplasty using 3D porous cup (SQRUM TT)
Total hip arthroplasty using HA-coating cup (SQRUM HA)
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Primary total hip arthroplasty
2) Age: 20-75 years old
3) Male and Female
4) Patients with the ability of consent and writing
5) Patients who can visit hospital as scheduled during the research period
1) Patients with immature bone structure
2) Patients with the loss of abduction muscle in affected leg
3) Patients with insufficient bone mineral density (e.g. Corticosteroid-induced metabolic bone disease)
4) Patients with insufficient skin covering around the hip joint
5) Patients with neuromuscular disease (e.g. Charcot disease) in affected leg
6) Patients with the infection (e.g. osteomyelitis in proximal femur or purulent infection in the hip joint)
7) Patients with radiation osteonecrosis of acetabulum
8) Patients with systemic or local infection
9) Patients with vascular interruption in affected leg
10) Patients without the ability of walking at the postoperative time
11) Suspicious patients with metal allergy
12) Pregnant patients, pregnant suspicious patients, or patients who hope for pregnancy
13) Patients with the disease which can affect consent or evaluation of the study, including dementia, schizophrenia, depression, panic disorder, or generalized anxiety disorder
14) Patients who need to undergo the lower extremity surgery within six months after participating in the study, including total hip arthroplasty and total knee arthroplasty
15) Patients who underwent the lower extremity surgery within six months before participating in the study, including total hip arthroplasty, total knee arthroplasty, or osteotomy
16) Patients who doctors judged unsuitable for the study
100
1st name | Shinya |
Middle name | |
Last name | Kawahara |
Graduate School of Medical Sciences, Kyushu University
Department of Orthopaedic Surgery
812-8582
3-1-1 Maidashi, Higashi-ku, Fukuoka
092-642-5488
kawahara.shinya.310@m.kyushu-u.ac.jp
1st name | Shinya |
Middle name | |
Last name | Kawahara |
Graduate School of Medical Sciences, Kyushu University
Department of Orthopaedic Surgery
812-8582
3-1-1 Maidashi, Higashi-ku, Fukuoka
092-642-5488
kawahara.shinya.310@m.kyushu-u.ac.jp
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Nothing in particular
Other
Research Support Division, Kyushu University
3-1-1 Maidashi, Higashi-ku, Fukuoka
092-642-5082
byskenkyu@jimu.kyushu-u.ac.jp
NO
九州大学病院(福岡県)
2020 | Year | 08 | Month | 11 | Day |
Unpublished
102
No longer recruiting
2020 | Year | 08 | Month | 11 | Day |
2020 | Year | 08 | Month | 07 | Day |
2020 | Year | 08 | Month | 11 | Day |
2025 | Year | 04 | Month | 30 | Day |
2020 | Year | 08 | Month | 10 | Day |
2024 | Year | 02 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047239
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