Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital of Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of Questionnaire of International Knee Documentation Committee (IKDC Questionnaire)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 40 years
- •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)
- •Tegner Activitiy Level of 5-
- •Exclusion criteria
- •Professional athletes or military
- •Collateral ligament rupture
- •Full-thickness cartilage lesion visualized
- •TAL below 5
- •Meniscal tear grade III on MRI.
- •A history of deep vein thrombosis (DVT) or a disorder of the coagulative system
- •Claustrophobia
- •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
- •Hyperlaxity with a Beighton score of more than 4
排除标准
- 未提供
结局指标
主要结局
Change of Questionnaire of International Knee Documentation Committee (IKDC Questionnaire)
时间窗: IKDC questionnaire was measured at pre operation (0 month), 3rd month, 6th month, 12th month, 24th month
IKDC is a subjective patient reported outcome measure for knee specific disease. Scoring in range 0-100, which 0 is lowest score, and 100 is a highest score
次要结局
- Change of Lachman Test(at pre operation (0 month), 12th month, 24th month)
- Total cost of treatment(at 12th and 24 months)
- Change of Pivot shift test(at pre operation (0 month),12th month, 24th month)
- Change of Questionnaire of EQ5D(at pre operation (0 month),12th month, 24th month)