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

NCT05457452 | Unknown

• 1 other identifier: INDO321
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries; Arthroscopy; Braces

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Rolimeter 3 months post treatment

  Objective examination of knee stability using a rolymeter

  3 months

• Rolimeter 6 months post treatment

  Objective examination of knee stability using a rolymeter

  6 month

Study Arms (2)

Knee Brace

EXPERIMENTAL

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

Device: Knee Brace

No Knee Brace

NO INTERVENTION

Interventions

Knee Brace DEVICE

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.

Knee Brace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Department of Orthpaedic and Traumatology RSCM-FKUI

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (10)

• 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.

  PMID: 28195986 BACKGROUND

• 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.

  PMID: 27871652 BACKGROUND

• 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.

  PMID: 31009238 BACKGROUND

• 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.

  PMID: 29985059 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33294183 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11101104 BACKGROUND

• 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.

  PMID: 31763340 BACKGROUND

• 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.

  PMID: 12879225 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Danarto H Adhimukti

CONTACT

81382869313; danartohari123@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 14, 2022
• Study Start: August 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)