Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital in Indonesia (Cetjap-Asin)

Universitas Riau

Status: Active, not recruiting

Conditions: ACL Tear

Treatments: Procedure: ACL Reconstruction surgery and Rehabilitation Treatment

Study type: Observational

Funder types: Other

Identifiers

NCT04748328

KET-894

Details and patient eligibility

About

The study was a prospective observational analysis of cases with complete ACL tears. A study was conducted between February 2021 to December 2024. All the patients attending those hospitals' emergency or outpatient departments (OPD) with knee injuries were evaluated for an ACL tear. Patients who meet inclusion criteria and consent to participate in the study will be observed for two years. Patients in Arifin Achmad Hospital Pekanbaru will follow rehabilitation treatment and optional delayed reconstruction after 12 weeks if needed, while patients in some hospitals in Jakarta and Bandung (Cipto Mangunkusumo Hospital, Gatot Subroto Army Hospital, Hasan Sadikin Hospital) will perform early reconstruction treatment. After receiving informed consent, all subjects received a self-administered patient questionnaire containing the International Knee Documentation Committee (IKDC) score, EQ5D3L, and Tegner Activity Level (TAL) scores. These questionnaires will be measured at 0, 12, 24, 48, and 96 weeks. Clinical value of the Lachman test and pivot shift test will be performed. One independent orthopedic surgeon will keep all records and evaluate the results. All costs for the treatment will be accounted for.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Age between 18 to 40 years
2. Either sex
3. Isolated ACL tear not more than six weeks old to a previously uninjured knee or less than six months with showing acute symptoms (inflammation, swelling, knee effusion)
4. Tegner Activitiy Level of 5-9.

Exclusion criteria

1. Professional athletes or military
2. Collateral ligament rupture
3. Full-thickness cartilage lesion visualized
4. TAL below 5
5. Meniscal tear grade III on MRI.
6. Pregnancy
7. A history of deep vein thrombosis (DVT) or a disorder of the coagulative system
8. Claustrophobia
9. General systemic disease affecting physical function, any other condition or treatment interfering with the completion of the trial, including patients with metal devices or motion disorders
10. Hyperlaxity with a Beighton score of more than 4

Trial design

100 participants in 2 patient groups

ACL Reconstruction Group

Description:

This group received reconstruction treatment in Cipto Mangunkusumo Hospital, Gatot Subroto Hospital, Hasan Sadikin Hospital

Treatment:

Procedure: ACL Reconstruction surgery and Rehabilitation Treatment

Rehabilitation Group

Description:

This group received rehabilitation treatment with optional delayed reconstruction if needed in Arifin Achmad Hospital, Pekanbaru

Treatment:

Procedure: ACL Reconstruction surgery and Rehabilitation Treatment