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Functional Outcomes Comparison in Patients Using Knee Brace Post ACL Reconstruction With Autograft Bone Quadricep Tendon

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05457452
Acronym
ACL
Enrollment
32
Registered
2022-07-14
Start date
2022-08-01
Completion date
2023-03-01
Last updated
2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries, Arthroscopy, Braces

Keywords

Anterior Cruciate Ligament Injuries, Arthroscopy, Knee Braces, Functional Outcome

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.

Interventions

Installation of an angle-adjustable knee brace, used after ACL reconstruction performed by an orthopedic specialist or orthopedic PPDS with the first week the angle locked at 00, in the second week the angle 0-900, in the third week the angle 0-1200, and the fourth week the angle of flexion full. Braces are used except for physical therapy according to the rehabilitation protocol in the first week.

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

All patients at Cipto Mangunkusumo Hospital and Gatot Soebroto Hospital, who underwent ACL reconstruction in the period January 2022 - January 2022 who met the inclusion and exclusion criteria.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
International Knee Documentation Committee (IKDC) score 3 months post treatment3 monthsPatients 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
International Knee Documentation Committee (IKDC) score 6 months post treatment6 monthsPatients 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 3 months post treatment3 monthsPatients were interviewed by the examiner based on the questions in the Lysholm form. Scale from 0 to 100. Higher score means better clinical outcomes
Lysholm score 6 months post treatment6 monthsPatients 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 treatment3 monthsThe 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 treatment6 monthsThe 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 3 months post treatment3 monthsPatients 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
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score 6 months post treatment6 monthsPatients 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
Rolimeter 3 months post treatment3 monthsObjective examination of knee stability using a rolymeter
Rolimeter 6 months post treatment6 monthObjective examination of knee stability using a rolymeter

Countries

Indonesia

Contacts

Primary ContactDanarto H Adhimukti
danartohari123@gmail.com81382869313

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026