ACL-PET

JRCT ID: jRCT1041220111

Registered date:26/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: ACL injury
• Date of first enrollment: 26/12/2022
• Target sample size: 10
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Skeletal muscle accumulation in PET images
• Secondary Outcome: Evaluate the impact of tendon graft harvesting by comparing results with previous healthy athletes

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Nakase Junsuke
• Source(s) of Monetary Support: TOBE MAKI Scholarship Foundation, SHIBUYA SCIENCE CULTURE AND SPORTS FOUNDATION