UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027498 |
|---|---|
| Receipt number | R000031492 |
| Scientific Title | New application of collagen membrane for less invasive procedure of autologous cultured cartilage implantation |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2019/08/13 08:43:46 |
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Basic information
Public title
New application of collagen membrane for less invasive procedure of autologous cultured cartilage implantation
Acronym
New application of collagen membrane for autologous cultured cartilage implantation
Scientific Title
New application of collagen membrane for less invasive procedure of autologous cultured cartilage implantation
Scientific Title:Acronym
New application of collagen membrane for autologous cultured cartilage implantation
Region
| Japan |
Condition
Condition
Full-thickness articular cartilage defects of the knee due to trauma or osteochondritis dissecans
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate safety and efficacy of collagen membrane for the autologous chondrocyte implantation (ACI) to eliminate periosteum harvest for less invasive procedure and to deliver more simple procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical score from Knee Injury and Osteoarthritis Outcome Score (KOOS) sheet obtained at registration, 26 weeks, and 52 weeks after implantation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
JACC (autologous cultured cartilage) will be prepared by Japan Tissue Engineering Co., Ltd following established protocol and delivered to our hospital with certified quality.
Patients will be admitted to the Hiroshima University Hospital with general manner and anesthetized at operation room (anesthesia method will be decided by anesthesiologist).
Under anesthesia, a medial or lateral parapatellar arthrotomy will be carried out to approach lesions. The lesion will be debrided as far as normal surrounding cartilage and until healthy subchondral bone. The defect was covered by a sutured collagen membrane. The membrane was shaped and sutured to the surrounding rim of normal cartilage with interrupted 5-0 nylon and loosely tied 4-0 vicryl sutures. After suturing half of the border of the membrane, the JACC will be placed in the defect, and then remaining border of the membrane will be sutured. Pull-out suture will be applied if it will be required to cover JACC. The joint capsule, retinaculum, and skin were sutured in separate layers. The grafted site will be confirmed its stability during range of motion before wound closure.
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Over 13 year old
2. Diagnosed as chondral lesion due to trauma or osteochondritis dissecans of the knee
3. Lesion size is over 4cm2
4. Patients consented to being enrolled this study with specific form
Key exclusion criteria
1. Patient who is diagnosed as oteoarthritis of the knee
2. Patient who is diagnosed or suspected malignant tumor
3. Patient who has complications and considered as inappropriate case by orthopaedic surgeon in charge.
4. Hypersensitive patients against gentamicin, amphotericin B, or amnoglycoside.
5. Hypersensitive patients against intradermal injection of atelocollagen or bovine product.
6. Patient who has allergic reaction to bovine or swine.
7. Patient who is diagnosed as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, autoimmune thyropathy, multiple arteritis, scleroderma, ulcerative colitis, Crohn's disease, Sjogren's syndrome, Reiter's syndrome, mixed connective tissue dissase.
8. Patient who has past history about anaphylactic shock.
9. Patient who has hypersensitive against atelocollagen.
10. Patient who is considered as inappropriate case by orthopaedic surgeon in charge.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuo Adachi |
Organization
Hiroshima University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5230
nadachi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Ishikawa |
Organization
Hiroshima University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5233
Homepage URL
mishikawa@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Tissue Engineering Co., Ltd.
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
Address
Tel
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 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 25 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031492
