Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital in Indonesia (Cetjap-Asin)

May 23, 2024 updated by: Romy Deviandri, Universitas Riau

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Riau
      • Pekanbaru, Riau, Indonesia, 28133
        • Arifin Achmad Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Young active population

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ACL Reconstruction Group
This group received reconstruction treatment in Cipto Mangunkusumo Hospital, Gatot Subroto Hospital, Hasan Sadikin Hospital
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
Rehabilitation Group
This group received rehabilitation treatment with optional delayed reconstruction if needed in Arifin Achmad Hospital, Pekanbaru
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Questionnaire of International Knee Documentation Committee (IKDC Questionnaire)
Time Frame: 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
IKDC questionnaire was measured at pre operation (0 month), 3rd month, 6th month, 12th month, 24th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Lachman Test
Time Frame: at pre operation (0 month), 12th month, 24th month
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
Change of Pivot shift test
Time Frame: at pre operation (0 month),12th month, 24th month
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
Change of Questionnaire of EQ5D
Time Frame: at pre operation (0 month),12th month, 24th month
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
Total cost of treatment
Time Frame: at 12th and 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 6, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KET-894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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