Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04748328
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2021-01-26
Brief Title:
Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital in Indonesia
Sponsor:
Universitas Riau
Organization:
Universitas Riau
Study Overview
Official Title:
Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital of Indonesia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cetjap-Asin
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None