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Japanese

Dec. 26, 2022

May. 07, 2024

jRCT1041220111

FDG-PET study of re-injury prevention training after ACL reconstruction

ACL-PET

Mar. 31, 2024

9

Adult male with a history of anterior cruciate ligament injury who underwent anterior cruciate ligament reconstruction. Age 19.9 +- 2.1 y.o., height 170.6 +- 2.1cm, body weight 71.2 +- 9.1kg

Ten patients were included in the study; five withdrew from the study due to last minute injury. PET-CT was performed after FIFA11+ for five patients. One withdrew due to injury. Four continued with FIFA11+ three times a week for one month. PET-CT was performed again for four patients. In twice PET-CTs, 44 skeletal muscle activities were evaluated by measuring SUV values.

N/A

There were no significant differences in all skeletal muscle activities in the first trial compared between the operative and nonoperative sides. At pre- and post-training after one month of continuation, there was a significant difference only in the Gemellus superior muscle (0.91 Vs. 1.5; p=0.041) on the operative side compared to the nonoperative side.

Adult male with a history of ACL reconstruction was continuously trained on FIFA 11+ for 1 month. Comparing the operative and nonoperative sides, only skeletal muscle activity of the Gemellus superior muscle increased on the operative side. These results suggest that FIFA11+, a disability prevention training program, may not be effective as a re-injury prevention program for patients who have undergone ACL reconstruction after only one month of continuation.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1041220111

Nakase Junsuke

Kanazawa University Hospital

13-1 Takaramachi, Kanazawa, Ishikawa

+81-76-265-2374

nakase1007@yahoo.co.jp

Kanayama Tomoyuki

Kanazawa University Hospital

13-1 Takaramachi, Kanazawa, Ishikawa

+81-76-265-2374

ortho.kanayama@gmail.com

Complete

Dec. 26, 2022

10

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

1) Patients who have undergone reconstructive surgery for anterior cruciate ligament injuries
2) Adult male patients who understand the study and are able to exercise using the FIFA11+.
3) Patients who have given their free and voluntary written consent to participate in this study after obtaining sufficient informed consent.

1) Those who have suffered an anterior cruciate ligament injury due to a cause other than sports trauma.
2) Persons who have been diagnosed with diabetes mellitus and are under treatment, or who have an HbA1c of 6.5% or higher without treatment.
3) Patients with a history of medical disease (e.g. heart failure) who should avoid exercise load
4) Patients with complaints in the lower limbs except knee joint pain
5) Subjects with a history of allergy to the drug (18F-FDG) after undergoing a PET scan in the past
6) Subjects who are judged to be inappropriate as research subjects by the principal investigator or subinvestigator

18age old over
No limit

Male

ACL injury

On the study start date, the subject will perform 2 sets of FIFA11+ part 2, then receive 18F-FDG injection, and then perform another 2 sets of FIFA11+ part 2. 1 hour after the 18F-FDG injection, a PET scan will be performed. balance capacity measurement will be performed after FDG-PET imaging.
Subjects will then continue one set of FIFA11+ three times a week for one month, and will repeat the same study one month after the initial study.

ACL reconstruction

Muscle Stretching Exercises

D016118

D0525800

Skeletal muscle accumulation in PET images

Evaluate the impact of tendon graft harvesting by comparing results with previous healthy athletes

Toshifumi Gabata
TOBE MAKI Scholarship Foundation, SHIBUYA SCIENCE CULTURE AND SPORTS FOUNDATION
Not applicable
Clinical Trial Review Board of Kanazawa University Hospital
13-1, Takara-machi, Ishikawa, Ishikawa

+81-76-265-2048

hpsangak@adm.kanazawa-u.ac.jp
Approval

Dec. 02, 2022

none

History of Changes

No Publication date
3 May. 07, 2024 (this page) Changes
2 Aug. 09, 2023 Detail Changes
1 Dec. 26, 2022 Detail