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

NCT ID: NCT05457452

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-03-01

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Injuries Arthroscopy Braces

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Knee Brace

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

Group Type EXPERIMENTAL

Knee Brace

Intervention Type 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.

No Knee Brace

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Danarto Hari Adhimukti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Orthpaedic and Traumatology RSCM-FKUI

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

Central Contacts

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Danarto H Adhimukti

Role: CONTACT

81382869313 ext. +62

Facility Contacts

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Danarto H Adhimukti, MD

Role: primary

81382869313 ext. +62

References

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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.

Reference Type BACKGROUND
PMID: 28195986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27871652 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31009238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29985059 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 33294183 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 11101104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31763340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12879225 (View on PubMed)

Other Identifiers

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INDO321

Identifier Type: -

Identifier Source: org_study_id

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