UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045005 |
|---|---|
| Receipt number | R000051411 |
| Scientific Title | Effect of patellar height and patellar tendon thickness on knee joint flexion range of motion after total knee arthroplasty |
| Date of disclosure of the study information | 2021/07/29 |
| Last modified on | 2025/02/10 01:49:00 |
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Basic information
Public title
Effects of patella height and patellar tendon thickness on the angle of knee joint bending after total knee arthroplasty
Acronym
Effects of patella height and patellar tendon thickness on the angle of knee joint bending after total knee arthroplasty
Scientific Title
Effect of patellar height and patellar tendon thickness on knee joint flexion range of motion after total knee arthroplasty
Scientific Title:Acronym
Effect of patellar height and patellar tendon thickness on knee joint flexion range of motion after total knee arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether patella height and patellar tendon thickness affect knee flexion range of motion after total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee flexion range of motion 3 weeks after surgery
Key secondary outcomes
Patella height 3 weeks after surgery
Patellar tendon thickness 3 weeks after surgery
Preoperative range of motion of the knee joint
Preoperative patella height
Preoperative patellar tendon thickness
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A case of a patient diagnosed with medial osteoarthritis of the knee who underwent total knee arthroplasty using a minimally invasive surgery medial parapatellar approach.
Key exclusion criteria
Non-minimally invasive surgery
rheumatoid arthritis
dementia
cases in which examination or intervention could not be performed as ordered by a physician
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | masashi |
| Middle name | |
| Last name | watanabe |
Organization
Social medical corporation sokoukai gyoda general hospital
Division name
Department of Rehabilitation
Zip code
361-0056
Address
376 Mochida, Gyoda City, Saitama Prefecture
TEL
048-552-1111
reha2@gyoda-hp.or.jp
Public contact
Name of contact person
| 1st name | masashi |
| Middle name | |
| Last name | watanabe |
Organization
Social medical corporation sokoukai gyoda general hospital
Division name
Department of Rehabilitation
Zip code
361-0057
Address
3-5-11 Josai, Gyoda City, Saitama Prefecture
TEL
048-552-1111
Homepage URL
mmmw226@gmail.com
Sponsor or person
Institute
Social medical corporation sokoukai gyoda general hospital
Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social medical corporation sokoukai gyoda general hospita
Address
376 Mochida, Gyoda City, Saitama Prefecture
Tel
048-552-1111
reha2@gyoda-hp.or.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
| 2021 | Year | 07 | Month | 29 | 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
23
Results
No significant correlation with postoperative knee joint flexion range: Preoperative Blackburne-Peel (BP), patellar tendon thickness
No significant difference before and after surgery: BP preoperative 0.81, postoperative 0.76
Significant difference before and after surgery: Knee joint flexion range 127.83 degrees before surgery, 114.13 degrees after surgery
Patellar tendon thickness preoperative 0.32cm, postoperative 0.39cm
Results date posted
| 2024 | Year | 11 | Month | 05 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Physical therapy - clinical/research/education scheduled to be published later
Date of the first journal publication of results
Baseline Characteristics
All subjects in the final analysis were women. The mean age was 76.2years, and the mean BMI was 25.0.
Participant flow
A total of 22 patients (27 knees), consisting of 8 men and 14 women, were excluded, leaving 20 women (23 knees). The excluded cases were 4 cases of osteoarthritis other than medial type, 13 cases of non-minimally invasive surgical procedures, 9 cases of rheumatoid arthritis, and 1 case in which intervention could not be performed due to an infection within the hospital. In addition, the surgical procedure for total knee arthroplasty at our hospital changed from the medial parapatellar approach to the mid vastus approach during the study period, making it difficult to obtain the required amount of data according to the research plan.
Adverse events
none
Outcome measures
As the Shapiro-Wilk test did not show normality, the correlation was examined using Spearman's rank correlation coefficient with the dependent variable being the postoperative knee joint flexion range, and the independent variables being the Blackburne-Peel (BP), an index of patella height before and after surgery, and patellar tendon thickness. In addition, the preoperative and postoperative results for knee joint flexion range, patella height, and patellar tendon thickness were compared using the Wilcoxon signed rank sum test.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective cohort study
Subjects,recruitment period: 42 patients who underwent total knee arthroplasty at our hospital between July 2021 and November 2023. Target knee
Measurements: Preoperative and 3 weeks postoperative range of motion of knee joint flexion, Patellar height by plain X-ray (Blackburne-Peel(BP)), and patellar tendon thickness by ultrasound
Plain X-rays are taken with the doctor's prescription and approval, and are also used in regular total knee arthroplasty cases. The frequency and number of images taken are the same as in normal total knee arthroplasty cases
Postoperative ultrasound measurements were taken when permitted by the doctor after checking the wound condition
Patella height (BP) measurement method: The length of the perpendicular line from the inferior pole of the patella to the tibial joint line divided by the length of the patellar articular surface, and after surgery, the length of the perpendicular line from the inferior pole of the patella to the tangent of the distal femoral component parallel to the tibial osteotomy surface divided by the length of the patellar articular surface
Patellar tendon thickness measurement method: Patellar tendon images were acquired using a portable ultrasound device equipped with a linear probe
Patellar tendon thickness was measured twice at 1 cm distal to the lower pole of the patella and the average was used
Main results: Correlation coefficient values could not be listed due to character limit, so are listed below. BP: pre-op -0.36, post-op -0.15 Patellar tendon thickness: pre-op 0.31, post-op 0.01
The main results are the comparison before and after surgery, the age of participants, and the standard deviation of BMI. There was an error message when registering, and only the average value was listed in English
URL related to results and publications: The results will be published later in Physical Therapy - Clinical, Research and Education: https://saitama-pt.or.jp/pt-pre
Management information
Registered date
| 2021 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051411
