ACL TearCetjap-AsinNCT04748328
Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital in Indonesia
An observational study of ACL Tear, run by Universitas Riau at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- ACL Tear
- What is being tested?
- ACL Reconstruction surgery and Rehabilitation Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2021to 31 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Adult
Study population: Young active population
Who may be able to join
- 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.
Who cannot join
- Professional athletes or military
- Collateral ligament rupture
- Full-thickness cartilage lesion visualized
- TAL below 5
- Meniscal tear grade III on MRI.
- Pregnancy
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- ACL Tear
- Being tested
- ACL Reconstruction surgery and Rehabilitation Treatment
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL Reconstruction surgery and Rehabilitation TreatmentProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| ACL Reconstruction Group | This group received reconstruction treatment in Cipto Mangunkusumo Hospital, Gatot Subroto Hospital, Hasan Sadikin Hospital Receives: 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 Receives: Procedure: ACL Reconstruction surgery and Rehabilitation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: IKDC questionnaire was measured at pre operation (0 month), 3rd month, 6th month, 12th month, 24th month
Secondary outcomes (4)
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
Measured: at pre operation (0 month), 12th month, 24th month
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
Measured: at pre operation (0 month),12th month, 24th month
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.
Measured: at pre operation (0 month),12th month, 24th month
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
Measured: at 12th and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Mar 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universitas Riau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romy Deviandri, Universitas Riau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748328
- Sponsor's protocol ID
- KET-894
- Acronym
- Cetjap-Asin
- Status last verified
- May 2024
- First submitted
- 26 Jan 2021
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital of Indonesia
- ClinicalTrials.gov ID
- NCT04748328
- Acronym / sponsor ID
- Cetjap-Asin / KET-894
- Conditions
- ACL Tear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitas RiauUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL Reconstruction Group | – | Procedure: ACL Reconstruction surgery and Rehabilitation TreatmentThis group received reconstruction treatment in Cipto Mangunkusumo Hospital, Gatot Subroto Hospital, Hasan Sadikin Hospital |
| Rehabilitation Group | – | Procedure: ACL Reconstruction surgery and Rehabilitation TreatmentThis group received rehabilitation treatment with optional delayed reconstruction if needed in Arifin Achmad Hospital, Pekanbaru |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Young active population
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Professional athletes or military
- Collateral ligament rupture
- Full-thickness cartilage lesion visualized
- TAL below 5
- Meniscal tear grade III on MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL Reconstruction surgery and Rehabilitation TreatmentACL 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 | Procedure or surgery | ACL Reconstruction Group, Rehabilitation Group |
Primary outcome
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
4 secondary outcomes
Change of Lachman Test
Time frame: 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
Change of Questionnaire of EQ5D
Time frame: at pre operation (0 month),12th month, 24th month
Total cost of treatment
Time frame: at 12th and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Tear, run by Universitas Riau at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.