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

NCT04748328 | Active Not Recruiting DMC

• 1 other identifier: KET-894
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Tear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of Lachman Test

  at pre operation (0 month), 12th month, 24th month

• 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

• Total cost of treatment

  at 12th and 24 months

Study Arms (2)

ACL Reconstruction Group

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

Procedure: ACL Reconstruction surgery and Rehabilitation Treatment

Rehabilitation Group

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

Procedure: ACL Reconstruction surgery and Rehabilitation Treatment

Interventions

ACL Reconstruction surgery and Rehabilitation Treatment PROCEDURE

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

ACL Reconstruction Group; Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young active population

You may qualify if:

• Age between 18 to 40 years
• Either sex
• 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 5-9.

You may not qualify if:

• Professional athletes or military
• Collateral ligament rupture
• Full-thickness cartilage lesion visualized
• TAL below 5
• Meniscal tear grade III on MRI.
• Pregnancy
• 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

Sponsors & Collaborators

• Universitas Riau: lead

Study Sites (1)

Arifin Achmad Hospital

Pekanbaru, Riau, 28133, Indonesia

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 10, 2021
• Study Start: March 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)