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

ACL Tear Clinical Trial

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

Clinical Trial Summary

The study was a prospective observational study analysis of cases having complete ACL tear. Study conduct between February 2021 to December 2023. All the patients attending the emergency or Out Patient Department (OPD) of those hospitals with knee injuries were evaluated for an ACL tear. Patients who meet inclusion criteria and give consent for participation in the study will observe for two years. Patient in Arifin Achmad Hospital Pekanbaru will follow rehabilitation treatment and optional delayed reconstruction after 12 weeks, while patient in Gatot Subroto Army Hospital Jakarta will performed early reconstruction treatment. After taking informed consent, all subjects were provided a self-administered patient questionnaire containing International Knee Documentation Committee (IKDC) score, ACL-RSI, Lysholm, and Tegner Activity Level (TAL) scores. These questionnaires will be measured at 0, 12, 24, 48, and 96 weeks. Besides that, all subjects were provided SF12 for measuring utility value by converting to SF6D. Clinical value of the Lachman test, 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • ACL Tear
  • Anterior Cruciate Ligament Injuries
Clinical Trial Details
NCT number NCT04748328
Study type Observational [Patient Registry]
Source Universitas Riau
Contact Romy Deviandri, MD
Phone 6282121700071
Email romydeviandri@lecturer.unri.ac.id
Status Recruiting
Phase
Start date March 1, 2021
Completion date December 31, 2023
View Details
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