UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063632 |
|---|---|
| Receipt number | R000072825 |
| Scientific Title | Intraoperative Joint Gap Changes Before and After Medial Meniscus Resection During Total Knee Arthroplasty: A Prospective Single-Center Within-Knee Comparative Study Using a FuZion Tensor |
| Date of disclosure of the study information | 2026/11/15 |
| Last modified on | 2026/11/15 00:57:39 |
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Basic information
Public title
Changes in Joint Gap Before and After Medial Meniscus Resection During Total Knee Arthroplasty
Acronym
TKA-MM GAP Study
Scientific Title
Intraoperative Joint Gap Changes Before and After Medial Meniscus Resection During Total Knee Arthroplasty: A Prospective Single-Center Within-Knee Comparative Study Using a FuZion Tensor
Scientific Title:Acronym
TKA-MM GAP Study
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to quantify changes in the medial joint gap at 0 degrees es of extension and 90 degrees of flexion before and after resection of the residual medial meniscus during total knee arthroplasty. Secondary objectives are to evaluate changes in the lateral joint gap, center gap, and tilt, and to explore associations between residual medial meniscal height and width and changes in the joint gap.
Basic objectives2
Others
Basic objectives -Others
Quantitative assessment of immediate intraoperative joint gap changes associated with medial meniscus resection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the medial joint gap (mm) before and after medial meniscus resection at (1) 0 degrees of extension and (2) 90 degrees of flexion. The gap will be measured twice at each position before and immediately after resection using a FuZion tensor. The change will be calculated as the difference between the mean post-resection and pre-resection measurements (post-resection minus pre-resection).
Key secondary outcomes
(1) Changes in the lateral joint gap (mm), center gap (mm), and tilt (degrees) at 0 degrees of extension and 90 degrees of flexion before and immediately after medial meniscus resection. (2) Exploratory associations between residual medial meniscal height and width (mm) and changes in the medial joint gap. Gap and tilt changes will be calculated from the mean of two repeated measurements at each time point (post-resection minus pre-resection).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo primary total knee arthroplasty (TKA) for knee osteoarthritis.
2. Patients aged 18 years or older.
3. Patients scheduled to undergo resection of the anterior cruciate ligament, posterior cruciate ligament, lateral meniscus, and medial meniscus as part of routine surgery.
4. Patients in whom intraoperative joint gap measurements can be performed according to the study protocol.
5. Patients who provide written informed consent after receiving an explanation of the study.
Key exclusion criteria
1. Patients undergoing revision total knee arthroplasty.
2. Patients without evaluable residual medial meniscal tissue due to previous total meniscectomy or other causes.
3. Patients with infectious joint disease.
4. Patients with severe ligament insufficiency or bone defects that prevent safe intraoperative gap measurements.
5. Patients requiring medial meniscus resection for clinical reasons before the study measurements.
6. Patients considered unsuitable for the study by the principal investigator for safety reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | RYUJII |
| Middle name | |
| Last name | ICHIMURA |
Organization
Minamikawa Orthopaedic Hospital
Division name
Department of Orthopaedics
Zip code
819-0002
Address
4-14-17 Meinohama, Nishi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-891-1234
ryuji53@hotmail.co.jp
Public contact
Name of contact person
| 1st name | RYUJI |
| Middle name | |
| Last name | ICHIMURA |
Organization
Minamikawa Orthopaedic Hospital
Division name
Department of Orthopaedics
Zip code
819-0002
Address
4-14-17 Meinohama, Nishi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-891-1234
Homepage URL
ryuji53@hotmail.co.jp
Sponsor or person
Institute
Minamikawa Orthopaedic Hospital
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
Minamikawa Orthopaedic Hospital Ethics Committee
Address
4-14-17 Meinohama, Nishi-ku, Fukuoka, Fukuoka, Japan
Tel
092-891-1234
yamaguchi@minamikawa-hp.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study involving patients undergoing total knee arthroplasty for varus knee osteoarthritis. Intraoperative joint gaps at 0 degrees of extension and 90 degrees of flexion are measured using a FuZion tensor before and after medial meniscus resection. Changes in joint gaps are compared within the same knee. Additional measurements are performed for research purposes, without modification of the standard surgical procedure or treatment strategy.
The study protocol was finalized on October 22, 2026, and approved by the institutional ethics committee on October 28, 2026 (approval number: 2026-2). The study commenced on November 4, 2026. Intraoperative measurements were performed in one knee before registration in the UMIN Clinical Trials Registry.
Management information
Registered date
| 2026 | Year | 11 | Month | 15 | Day |
Last modified on
| 2026 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072825
