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Clinical Trials/NCT05457452
NCT05457452
Unknown
Not Applicable

Comparison of Functional Outcomes in Patients Using Knee Brace and Without Knee Brace After Anterior Cruciate Ligament Reconstruction Surgery With Autograft Bone Quadricep Tendon Arthroscopy

Indonesia University1 site in 1 country32 target enrollmentAugust 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Injuries
Sponsor
Indonesia University
Enrollment
32
Locations
1
Primary Endpoint
Lysholm score 3 months post treatment
Last Updated
3 years ago

Overview

Brief Summary

This study is a study looking for the relationship between variables with a prospective cohort design to determine functional outcomes subjectively and objectively in patients with and without braces after ACL reconstruction with bone quadriceps tendon per arthroscopy.

Detailed Description

This study is a study looking for the relationship between variables with a prospective cohort design to determine functional outcomes subjectively and objectively in patients with and without braces after ACL reconstruction with bone quadriceps tendon per arthroscopy. The research will be conducted at the National Central General Hospital dr. Cipto Mangunkusumo, Jakarta Police Hospital and Gatot Soebroto Army Hospital in Jakarta, Indonesia.

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
March 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Danarto Hari Adhimukti

Principal Investigator

Indonesia University

Eligibility Criteria

Inclusion Criteria

  • Adult patients with age more than equal to 18 years
  • Patients with ACL rupture without other ligament ruptures undergoing ACL reconstruction
  • Patients undergoing ACL reconstruction using Quadricep Tendon Autograft

Exclusion Criteria

  • Patients with hyperlaxity
  • Patients with previous history of ACL reconstruction
  • Patients with recurrent rupture during the observation period

Outcomes

Primary Outcomes

Lysholm score 3 months post treatment

Time Frame: 3 months

Patients were interviewed by the examiner based on the questions in the Lysholm form. Scale from 0 to 100. Higher score means better clinical outcomes

International Knee Documentation Committee (IKDC) score 6 months post treatment

Time Frame: 6 months

Patients were interviewed by the examiner based on questions in the International Knee Documentation Committee (IKDC) form. Scale from 0 to 100. Higher score means better clinical outcomes

Lysholm score 6 months post treatment

Time Frame: 6 months

Patients were interviewed by the examiner based on the questions in the Lysholm form. Scale from 0 to 100. Higher score means better clinical outcomes

Knee injury and Osteoarthritis Outcome (KOOS) score 3 months post treatment

Time Frame: 3 months

The patient was interviewed by the examiner according to the KOOS Questionnaire form. Scale from 0 to 100. Higher score means better clinical outcomes

Knee injury and Osteoarthritis Outcome (KOOS) score 6 months post treatment

Time Frame: 6 months

The patient was interviewed by the examiner according to the KOOS Questionnaire form. Scale from 0 to 100. Higher score means better clinical outcomes

Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score 6 months post treatment

Time Frame: 6 months

Patients were interviewed by the examiner based on the questions on the Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) form. Scale from 0 to 100. Higher score means better clinical outcomes

International Knee Documentation Committee (IKDC) score 3 months post treatment

Time Frame: 3 months

Patients were interviewed by the examiner based on questions in the International Knee Documentation Committee (IKDC) form. Scale from 0 to 100. Higher score means better clinical outcomes

Rolimeter 3 months post treatment

Time Frame: 3 months

Objective examination of knee stability using a rolymeter

Rolimeter 6 months post treatment

Time Frame: 6 month

Objective examination of knee stability using a rolymeter

Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score 3 months post treatment

Time Frame: 3 months

Patients were interviewed by the examiner based on the questions on the Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) form. Scale from 0 to 100. Higher score means better clinical outcomes

Study Sites (1)

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