Trials / Active Not Recruiting
Active Not RecruitingNCT04748328
Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital in Indonesia
Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital of Indonesia
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Universitas Riau · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | ACL Reconstruction surgery and Rehabilitation Treatment | ACL Reconstruction surgery is a procedure to treat ACL injury by replacing the torn ligament with another. ACL Rehabilitation treatment is a procedure to treat ACL injury by muscle strengthening and exercise |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2024-06-30
- Completion
- 2024-12-31
- First posted
- 2021-02-10
- Last updated
- 2024-05-28
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT04748328. Inclusion in this directory is not an endorsement.