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NCT05457452 Clinical Trial

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

Anterior Cruciate Ligament Injuries Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05457452
Other study ID # INDO321
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date March 1, 2023

Study information
Verified date July 2022
Source Indonesia University
Contact Danarto H Adhimukti
Phone 81382869313
Email danartohari123@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 32
Est. completion date March 1, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Knee Brace
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.

Locations
Country Name City State
Indonesia Department of Orthpaedic and Traumatology RSCM-FKUI Jakarta Pusat Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (10)

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. — View 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.

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. — View Citation

Kaeding CC, Léger-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. Review. — View 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. Review. — View 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. — View 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. Epub 2003 Jul 16. — View 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. — View 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. — View 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

Outcome
Type Measure Description Time frame Safety issue
Primary 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 3 months
Primary 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 6 months
Primary 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 3 months
Primary 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 6 months
Primary 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 3 months
Primary 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 6 months
Primary 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 3 months
Primary 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 6 months
Primary Rolimeter 3 months post treatment Objective examination of knee stability using a rolymeter 3 months
Primary Rolimeter 6 months post treatment Objective examination of knee stability using a rolymeter 6 month
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