UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022345 |
|---|---|
| Receipt number | R000025253 |
| Scientific Title | A study on the effect of teriparatide acetate injections in the rotator cuff tear repair. |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/11/07 20:35:22 |
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Basic information
Public title
A study on the effect of teriparatide acetate injections in the rotator cuff tear repair.
Acronym
A study on the effects of teriparatide in the ARCR.
Scientific Title
A study on the effect of teriparatide acetate injections in the rotator cuff tear repair.
Scientific Title:Acronym
A study on the effects of teriparatide in the ARCR.
Region
| Japan |
Condition
Condition
Rotator cuff tear, osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whether administration of teriparatide acetate raises the rotator cuff healing rate of the ARCR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At postoperative 12 weeks of ARCR, the healing rate and cuff integrity of the repaired rotator cuff compared with the control group and teriparatide acetate group.
Key secondary outcomes
The Pain by visual analog scale, Constant score, JOA score and WORC index compare with the control group and teriparatide acetate group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Teriparatide acetate group
Interventions/Control_2
Control group
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients of 50 y.o or older female.
2) Patients who underwent surgery in our hospital.
3) Patients who had been diagnosed with rotator cuff tear and osteoporosis.
4) Patients with rotator cuff tear size is large or more.
5) Patients who obtained the consent in this study.
6) Patients who were able to complete the surgery by suture bridge technique under arthroscopic.
Key exclusion criteria
1) Patients with intrinsic disease (osteoarthritis, rheumatoid arthritis, calcific tendinitis, infection, metabolic disorders etc)
2) Patients with metabolic diseases (hypercalcemia, hyperparathyroidism, hypothyroidism etc)
3) Extrinsic disease (trauma, after surgery, neuromuscular diseases, congenital malformation etc)
4) Patients with cervical disease
5) Patients with severe diabetes mellitus
6) Patients with liver failure, renal failure and with the history.
7) Patients with malignant tumor or metastatic tumor.
8) Workers' compensation patients
9) Patients with skin disease or infection at the injection site
10) Patients with a history of allergy to the components of this drug.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Yozo |
| Middle name | |
| Last name | Shibta |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Orthpaedic Surgery
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino, Fukuoka JAPAN
TEL
092-921-1011
yshibata.01@me.com
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Minamikawa |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Orthpaedic Surgery
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino, Fukuoka JAPAN
TEL
092-921-1011
Homepage URL
tomominamikawa@yahoo.co.jp
Sponsor or person
Institute
Department of Orthpaedic Surgery, Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Orthpaedic Surgery, Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Chikushi Hospital
Address
1-1-1 Zokumyoin, Chikushino, Fukuoka JAPAN
Tel
092-921-1011
tomominamikawa@yahoo.co.jp
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
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025253
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| Registered date | File name |
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