UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033950 |
|---|---|
| Receipt number | R000038721 |
| Scientific Title | Comparative study in three-dimensional tibiofemoral kinematics during mid flexion lunge in a PCL substituting TKA for knee osteoarthritis |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2024/09/15 23:52:37 |
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Basic information
Public title
Comparative study in three-dimensional tibiofemoral kinematics during mid flexion lunge in a PCL substituting TKA for knee osteoarthritis
Acronym
3-D tibiofemoral kinematics during mid flexion lunge in a PCL substituting TKA
Scientific Title
Comparative study in three-dimensional tibiofemoral kinematics during mid flexion lunge in a PCL substituting TKA for knee osteoarthritis
Scientific Title:Acronym
3-D tibiofemoral kinematics during mid flexion lunge in a PCL substituting TKA
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diffrerences in three dimentional tibiofemoral kinematics during mid flexion lunge between a posterior-stabilized and a cruciate-substituting total knee arthroplasty in a prospective randomized trial
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Patient-based clinical evaluation
2.ragiographic evaluation
3.kinematics analysis using the 2D/3D image registration technique
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Total Knee Arthroplasty
Interventions/Control_2
Radiographic evalaution before and six moths after surgery
Interventions/Control_3
Kinematic analysisusing the 2D/3D image matching technique at six moths after surgery
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Medial ostoarthritis of unilateral or both knees
2. The patients who agreed the informed consent of participation in this study
Key exclusion criteria
1. The patients underwent the previou surgery in the involved limb
2. The patient with previous osteomyelitis
3. Active flexion angle of the knee less than 120 degrees
4. The patient who refused the participation of this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakamura |
Organization
Kumamoto University Medical Hospital
Division name
Deaprtment of Orthopaedic Surgery
Zip code
860-8556
Address
1-1-1, Honjyo, Chuo-ku, Kumamoto, 860-8556
TEL
096-373-5226
h@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakamura |
Organization
Kumamoto University Medical Hospital
Division name
Deaprtment of Orthopaedic Surgery
Zip code
860-8556
Address
1-1-1, Honjyo, Chuo-ku, Kumamoto, 860-8556
TEL
096-373-5226
Homepage URL
h@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Kumamoto University Medical Hospital
Institute
Department
Personal name
Funding Source
Organization
MicroPort Orthopedics Inc.,
5677 Airline Road, Arlington, TN 38002, U.S.A.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
U.S.A.
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Research Board
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-City, Kumamoto, 8508556, Japan
Tel
096-373-5966
byi-senshin@jimu.kumamoto-u.ac.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
| 2018 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
UMIN000033950
Publication of results
Published
Result
URL related to results and publications
Knee Surg Sports Traumatol Arthrosc . 2024 Aug 5. doi: 10.1002/ksa.12399. Online ahead of print.
Number of participants that the trial has enrolled
36
Results
Eighteen patients in each arm completed 1 year follow up and were included in the analysis. During lunge and step up activities, a medial pivot motion was observed in 83% and 72% of knees in the MP arm, respectively, compared with 22% and 11% in the PS arm. Despite these differences in kinematics, there were no statistically significant differences in the KSS and KOOS between the two groups.
Results date posted
| 2024 | Year | 09 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria included patients with symptomatic medial osteoarthritis requiring primary TKA, Kellgren-Lawrence knee osteoarthritis grade>3, age at surgery>60, femorotibial angle<190 degrees on a standing anteroposterior radiograph, and preoperative active knee flexion>120 degrees. Patients with rheumatoid arthritis, valgus deformity of the affected knee, concurrent hip and ankle OA, previous knee osteotomy, old periarticular fractures, preexisting contralateral TKA, or cognitive or neurological conditions were excluded.
Participant flow
The inclusion criteria included patients with symptomatic medial osteoarthritis requiring primary TKA, Kellgren-Lawrence knee osteoarthritis grade>3, age at surgery>60, femorotibial angle<190 degrees on a standing anteroposterior radiograph, and preoperative active knee flexion>120 degrees. Patients with rheumatoid arthritis, valgus deformity of the affected knee, concurrent hip and ankle OA, previous knee osteotomy, old periarticular fractures, preexisting contralateral TKA, or cognitive or neurological conditions were excluded.
Adverse events
none
Outcome measures
KSS, KOOS, Kinematics
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2018 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038721
