Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital in Indonesia

ACL Tear Clinical Trial

— Cetjap-Asin  

Official title:

Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital of Indonesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04748328
• Other study ID #: KET-894
• Status: Active, not recruiting
• Start date: March 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Universitas Riau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Tear
• Anterior Cruciate Ligament Injuries

Intervention

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

Locations

Country	Name	City	State
Indonesia	Arifin Achmad Hospital	Pekanbaru	Riau

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Riau

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Questionnaire of International Knee Documentation Committee (IKDC Questionnaire)	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	IKDC questionnaire was measured at pre operation (0 month), 3rd month, 6th month, 12th month, 24th month
Secondary	Change of Lachman Test	Lachman test was measured by passive movement of the knee at 30 degree of flexion, Grade 1: 3-5mm translation of the tibia Grade 2: 5-10 mm more translation of the tibia Grade 3: translation of the tibia more than 10mm	at pre operation (0 month), 12th month, 24th month
Secondary	Change of Pivot shift test	Pivot shift test was measured by valgus and slowly flexion the knee, Grade 1: gentle twisting slide with tibia twisting internally maximally Grade 2: Clunk with tibia in neutral position Grade 3: painless glide for examiner and patient	at pre operation (0 month),12th month, 24th month
Secondary	Change of Questionnaire of EQ5D	The EQ5D questionnaire is a generic patient-reported outcome measure for measuring a patient's quality of life. Its scores range from -0,865 to 1 in the Indonesian population particularly.	at pre operation (0 month),12th month, 24th month
Secondary	Total cost of treatment	Total cost for surgery treatment or rehabilitation treatment in Rupiah (Indonesian currency). Cost was taken account by direct interview to the patient and direct observation to medical account in the hospital	at 12th and 24 months