UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026894 |
|---|---|
| Receipt number | R000030844 |
| Scientific Title | Prospective Multicenter Clinical Research to Investigate the Safety and Efficacy of Conjoined Tendon-Preserving Posterior Approach with Bipolar Hip Prosthesis |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2023/10/13 17:15:51 |
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Basic information
Public title
Prospective Multicenter Clinical Research to Investigate the Safety and Efficacy of Conjoined Tendon-Preserving Posterior Approach with Bipolar Hip Prosthesis
Acronym
Clinical research to investigate safety and efficacy of CPP approach
Scientific Title
Prospective Multicenter Clinical Research to Investigate the Safety and Efficacy of Conjoined Tendon-Preserving Posterior Approach with Bipolar Hip Prosthesis
Scientific Title:Acronym
Clinical research to investigate safety and efficacy of CPP approach
Region
| Japan |
Condition
Condition
Femoral Neck Fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is conducted to investigate safety and efficacy on CPP approach.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dislocation rate etc.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in whom BHA with the CPP approach is indicated.
Other.
Key exclusion criteria
Patients who cannot cooperate in this research in the investigator is judgment.
Other.
Target sample size
322
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Nakamura |
Organization
Toyama Prefectural Central Hospital
Division name
Orthopedics
Zip code
930-8550
Address
2-2-78 Nishinagae, Toyama-shi, Toyama 930-8550, Japan
TEL
076-424-1531
mikiharu.morita@zimmerbiomet.com
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Nakai |
Organization
Zimmer Biomet G.K.
Division name
Clinical Affairs
Zip code
105-0011
Address
15F, Sumitomo Fudosan Shibakoen Tower 11-1, Shibakoen 2-Chome, Minato-ku, Tokyo 105-0011, Japan
TEL
0364026600
Homepage URL
takahito.nakai@zimmerbiomet.com
Sponsor or person
Institute
Zimmer Biomet G.K.
Institute
Department
Personal name
Funding Source
Organization
Zimmer Biomet G.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Toyama Prefectural Central Hospital
Address
2-2-78 Nishinagae, Toyama-shi, Toyama 930-8550, Japan
Tel
076-424-1531
takahito.nakai@zimmerbiomet.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000030844
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000030844
Number of participants that the trial has enrolled
322
Results
322 patients were enrolled. 320 patients received Bipolar Hemi-Hip Replacement via CPP approach. Of those, 249 (78%) patients were followed between 6 - 12 months after operation.
Primary Endpoint: No Postoperative Dislocation was reported.
Secondary Endpoints: 4 radiological findings were reported. Pain assessment revealed that 215 patient had no pain and 32 patients had pain at 6-12 months after operation.
Results date posted
| 2023 | Year | 10 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean age: 83.3 y.o.
239 females & 81 males
Mean body weight: 48.7 kg
Mean height: 153.0 cm
Mean BMI: 20.7 kg/m2
Participant flow
322 recruited/consented
320 operated (2 withdrawn before surgery)
306 successfully operated by CPP approach (14 CPP not successful)
302 followup at discharge (1 revision, 1 AE, 1 Protocol Deviation, 1 Death)
237 followup at 6-12 months (3 revisions, 22 deaths, 40 lost to followup)
Adverse events
46 adverse events were reported, including 37 Serious AEs. Four revisions were reported. None of them were related to implant/procedure.
Outcome measures
Postoperative dislocation: 0
Postoperative pain assessment: no pain in 215, 32 patients reported pain
Mobility status: 136 (54.6%) showed no change or improvement compared to preoperative status
Living Environment: 210 (84.3%) showed no change or improvement compared to preoperative status.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2017 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030844
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
