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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Arthroscopy
• Braces

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