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

Primary Purpose

Anterior Cruciate Ligament Injuries, Arthroscopy, Braces

Status
Not yet recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Knee Brace
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring Anterior Cruciate Ligament Injuries, Arthroscopy, Knee Braces, Functional Outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Orthpaedic and Traumatology RSCM-FKUI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Knee Brace

No Knee Brace

Arm Description

Use of a Knee Brace after ACL Reconstruction, the patient is put on a knee brace by an orthopedic doctor or orthopedic resident after ACL reconstruction

Outcomes

Primary Outcome Measures

International Knee Documentation Committee (IKDC) score 3 months post treatment
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
International Knee Documentation Committee (IKDC) score 6 months post treatment
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 3 months post treatment
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
Lysholm score 6 months post treatment
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
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
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 3 months post treatment
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
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score 6 months post treatment
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
Rolimeter 3 months post treatment
Objective examination of knee stability using a rolymeter
Rolimeter 6 months post treatment
Objective examination of knee stability using a rolymeter

Secondary Outcome Measures

Full Information

First Posted
July 2, 2022
Last Updated
July 11, 2022
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05457452
Brief Title
Functional Outcomes Comparison in Patients Using Knee Brace Post ACL Reconstruction With Autograft Bone Quadricep Tendon
Acronym
ACL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Arthroscopy, Braces
Keywords
Anterior Cruciate Ligament Injuries, Arthroscopy, Knee Braces, Functional Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Knee Brace
Arm Type
Experimental
Arm Description
Use of a Knee Brace after ACL Reconstruction, the patient is put on a knee brace by an orthopedic doctor or orthopedic resident after ACL reconstruction
Arm Title
No Knee Brace
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Knee Brace
Intervention Description
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.
Primary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC) score 3 months post treatment
Description
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
Time Frame
3 months
Title
International Knee Documentation Committee (IKDC) score 6 months post treatment
Description
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
Time Frame
6 months
Title
Lysholm score 3 months post treatment
Description
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
Time Frame
3 months
Title
Lysholm score 6 months post treatment
Description
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
Time Frame
6 months
Title
Knee injury and Osteoarthritis Outcome (KOOS) score 3 months post treatment
Description
The patient was interviewed by the examiner according to the KOOS Questionnaire form. Scale from 0 to 100. Higher score means better clinical outcomes
Time Frame
3 months
Title
Knee injury and Osteoarthritis Outcome (KOOS) score 6 months post treatment
Description
The patient was interviewed by the examiner according to the KOOS Questionnaire form. Scale from 0 to 100. Higher score means better clinical outcomes
Time Frame
6 months
Title
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score 3 months post treatment
Description
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
Time Frame
3 months
Title
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score 6 months post treatment
Description
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
Time Frame
6 months
Title
Rolimeter 3 months post treatment
Description
Objective examination of knee stability using a rolymeter
Time Frame
3 months
Title
Rolimeter 6 months post treatment
Description
Objective examination of knee stability using a rolymeter
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danarto H Adhimukti
Phone
81382869313
Ext
+62
Email
danartohari123@gmail.com
Facility Information:
Facility Name
Department of Orthpaedic and Traumatology RSCM-FKUI
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danarto H Adhimukti, MD
Phone
81382869313
Ext
+62
Email
danartohari123@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28195986
Citation
Lowe WR, Warth RJ, Davis EP, Bailey L. Functional Bracing After Anterior Cruciate Ligament Reconstruction: A Systematic Review. J Am Acad Orthop Surg. 2017 Mar;25(3):239-249. doi: 10.5435/JAAOS-D-15-00710.
Results Reference
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PubMed Identifier
27871652
Citation
Kaeding CC, Leger-St-Jean B, Magnussen RA. Epidemiology and Diagnosis of Anterior Cruciate Ligament Injuries. Clin Sports Med. 2017 Jan;36(1):1-8. doi: 10.1016/j.csm.2016.08.001. Epub 2016 Oct 4.
Results Reference
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PubMed Identifier
31009238
Citation
Montalvo AM, Schneider DK, Webster KE, Yut L, Galloway MT, Heidt RS Jr, Kaeding CC, Kremcheck TE, Magnussen RA, Parikh SN, Stanfield DT, Wall EJ, Myer GD. Anterior Cruciate Ligament Injury Risk in Sport: A Systematic Review and Meta-Analysis of Injury Incidence by Sex and Sport Classification. J Athl Train. 2019 May;54(5):472-482. doi: 10.4085/1062-6050-407-16. Epub 2019 Apr 22.
Results Reference
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PubMed Identifier
29985059
Citation
Chan CX, Wong KL, Toh SJ, Krishna L. Epidemiology of patients with anterior cruciate ligament injuries undergoing reconstruction surgery in a multi-ethnic Asian population. Res Sports Med. 2021 Jan-Feb;29(1):12-24. doi: 10.1080/15438627.2018.1492391. Epub 2018 Jul 9.
Results Reference
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Citation
Dzakiya FNA, Tinduh D, Utomo DN. Risk Estimation of Anterior Cruciate Ligament (ACL) Injury in East Java Puslatda Pencak Silat Athletes. Surabaya Phys Med Rehabil J. 2021;3:29.
Results Reference
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PubMed Identifier
33294183
Citation
Lubis AM, Dasril DF. Comparison of functional outcome between bone quadriceps tendon (BQT) and single-bundle hamstring tendon (SBHT) autograft in arthroscopic-assisted anterior cruciate ligament reconstruction cases: a prospective cohort study. Ann Med Surg (Lond). 2020 Nov 13;60:509-514. doi: 10.1016/j.amsu.2020.11.023. eCollection 2020 Dec.
Results Reference
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Citation
Rudy, Mustamsir E, Phatama KY. Tensile strength comparison between peroneus longus and hamstring tendons: A biomechanical study. Int J Surg Open [Internet]. 2017;9:41-4. Available from: https://doi.org/10.1016/j.ijso.2017.10.002
Results Reference
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PubMed Identifier
11101104
Citation
Fleming BC, Renstrom PA, Beynnon BD, Engstrom B, Peura G. The influence of functional knee bracing on the anterior cruciate ligament strain biomechanics in weightbearing and nonweightbearing knees. Am J Sports Med. 2000 Nov-Dec;28(6):815-24. doi: 10.1177/03635465000280060901.
Results Reference
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PubMed Identifier
31763340
Citation
Perrone GS, Webster KE, Imbriaco C, Portilla GM, Vairagade A, Murray MM, Kiapour AM. Risk of Secondary ACL Injury in Adolescents Prescribed Functional Bracing After ACL Reconstruction. Orthop J Sports Med. 2019 Nov 12;7(11):2325967119879880. doi: 10.1177/2325967119879880. eCollection 2019 Nov.
Results Reference
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PubMed Identifier
12879225
Citation
Melegati G, Tornese D, Bandi M, Volpi P, Schonhuber H, Denti M. The role of the rehabilitation brace in restoring knee extension after anterior cruciate ligament reconstruction: a prospective controlled study. Knee Surg Sports Traumatol Arthrosc. 2003 Sep;11(5):322-6. doi: 10.1007/s00167-003-0386-3. Epub 2003 Jul 16.
Results Reference
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Functional Outcomes Comparison in Patients Using Knee Brace Post ACL Reconstruction With Autograft Bone Quadricep Tendon

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