UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021279 |
|---|---|
| Receipt number | R000024340 |
| Scientific Title | Randomized controlled study comparing Vanguard with KneeAlign2 navigational system versus Vanguard conventional |
| Date of disclosure of the study information | 2016/03/02 |
| Last modified on | 2023/09/06 19:19:20 |
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Basic information
Public title
Randomized controlled study comparing Vanguard with KneeAlign2 navigational system versus Vanguard conventional
Acronym
Vanguard with/without KneeAlign 2
Scientific Title
Randomized controlled study comparing Vanguard with KneeAlign2 navigational system versus Vanguard conventional
Scientific Title:Acronym
Vanguard with/without KneeAlign 2
Region
| Japan |
Condition
Condition
Knee Joint Diseases
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine the effectiveness of the KneeAlign2 system in terms of precise implant alignment by demonstrating that KneeAlign2 provides better tibial alignment compared to conventional instruments
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of subjects that have alignment within 2 degrees from neutral on tibia at postoperative 6 months.
Key secondary outcomes
Surgery time, Tibial posterior slope alignment, Femoral varus/valgus angle, frequency to perform re-osteotomy for angle correction with KneeAlign2, and collection of adverse events/ adverse device effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Vanguard with KneeAlign 2 as investigational group.
Interventions/Control_2
Vanguard with conventional instrumentation and without KneeAlign 2 as 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only)
- Subjects willing to return for follow-up evaluations
Key exclusion criteria
- Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis)
- Severe OA deformation (FTA:> 185 degrees / < 175 degrees)
- Active Infection (or within 6 weeks after infection)
- Sepsis
- Osteomyelitis
- Any type of implant is inserted in the affected side of lower extremity
- Hip disease on the affected side
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- diagnosed Osteoporosis or Osteomalacia
- Metabolic disorders which may impair bone formation
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukihide |
| Middle name | |
| Last name | Minoda |
Organization
Osaka City University
Division name
Orthopaedic Surgery
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka, Japan
TEL
03-6402-6610
takahito.nakai@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
11-1, Shibakoen 2-chome, Minato-ku, Tokyo, Japan
TEL
03-6402-6610
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
Osaka City University Ethics Committee
Address
1-4-3 Asahimachi, Abeno-ku, Osaka, Japan
Tel
06-6645-3851
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
大阪市立大学（大阪）、国立病院機構 大阪南医療センター（大阪)、藤田保健衛生大学（愛知）、船橋整形外科病院（千葉）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 02 | Day |
Related information
URL releasing protocol
https://classic.clinicaltrials.gov/ct2/show/NCT02695329
Publication of results
Published
Result
URL related to results and publications
https://www.jbjs.org/reader.php?rsuite_id=2598684&native=1
Number of participants that the trial has enrolled
100
Results
There were no complications reported.
The absolute differences of the femoral prosthesis, tibial prosthesis, and hip-knee-ankle angle from a neutral mechanical axis were less in the navigation group compared with those in the conventional group. Alignment outliers of the tibial prosthesis and hip-knee-ankle angle were less in the navigation group (9% and 27%, respectively) compared with those in the conventional group (31% and 49%; p = 0.01 and p =0.04, respectively).
Results date posted
| 2023 | Year | 09 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Control: 50 cases (F 40, M 10)
Investigational: 50 caess (F 39, M 11)
Participant flow
Informed Consent: 100 cases
Randomized (Investigational group: 50 cases, Control group: 50 cases)
Excuded from analysis (Investigational group 5 cases, Control group 5 cases)
Analyzed: Investigational group 45 cases, control group 45 cases
Adverse events
No serious adverse event was reported.
Outcome measures
Radiographic Measurement
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 27 | 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 | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024340
