Clinical trial NCT04748328: Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital in Indonesia
Official title: Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital of Indonesia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: ACL Tear
Lead sponsor: Universitas Riau
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young active population

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change of Questionnaire of International Knee Documentation Committee (IKDC Questionnaire)
timeFrame: IKDC questionnaire was measured at pre operation (0 month), 3rd month, 6th month, 12th month, 24th month
Secondary outcomes:
measure: Change of Lachman Test
timeFrame: at pre operation (0 month), 12th month, 24th month
measure: Change of Pivot shift test
timeFrame: at pre operation (0 month),12th month, 24th month
measure: Change of Questionnaire of EQ5D
timeFrame: at pre operation (0 month),12th month, 24th month
measure: Total cost of treatment
timeFrame: at 12th and 24 months
Other outcomes:
Locations:
city: Pekanbaru
country: Indonesia
facility: Arifin Achmad Hospital
state: Riau
Study officials:
References: