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Comparison of the Functional Outcome of Site Peroneus Longus Graft Donors With and Without Distal Stump Suturing of Peroneus Tendon Brevis on ACL Reconstruction Case in Cipto Mangunkusumo Hospital in Jakarta With 24 Patient as Subject Who Will Divide Into 2 Group.

Primary Purpose

Rupture of Anterior Cruciate Ligament

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Distal Stump Suturing
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rupture of Anterior Cruciate Ligament focused on measuring ACL, Rupture of ACL, Donor site, Peroneus Longus Graft, Distal Stump, Peroneus Brevis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with total ACL rupture using peroneus longus graft
  • The suturing procedure for the distal stump peroneus longus against the peroneus brevis tendon is performed by orthopedic specialists or resident chiefs who have been given training in advance.

Exclusion Criteria:

  • Osteoarthtis Knee Kellgren-Lawrence III and IV
  • Osteoarthtis Knee Kellgren-Lawrence III and IV
  • Flatfoot as evidenced by physical examination and footprinting

Sites / Locations

  • Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sutured Stump

Unsutured Stump

Arm Description

The group consist of subject with distal stump suturing of perobeus longus agains peroneus brevis in ACL Reconstruction Case

The group consist of subject without distal stump suturing of peroneus longus agains peroneus brevis in ACL Reconstruction Case

Outcomes

Primary Outcome Measures

Preoperative hand dynamometer value
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Three-months postoperative hand dynamometer value
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Six-months postoperative hand dynamometer value
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Preoperative Clark's Angle Value
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Three-months Clark's Angle Value
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Six-months Clark's Angle Value
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Preoperative the American Orthopedic Foot and Ankle Score (AOFAS)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Three months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Six months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Preoperative visual analogue scale foot and ankle (VAS-FA)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. VAS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Three-months postoperative visual analogue scale foot and ankle (VAS-FA)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Six-months postoperative visual analogue scale foot and ankle (VAS-FA)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible

Secondary Outcome Measures

Full Information

First Posted
June 3, 2020
Last Updated
May 20, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04431063
Brief Title
Comparison of the Functional Outcome of Site Peroneus Longus Graft Donors With and Without Distal Stump Suturing of Peroneus Tendon Brevis on ACL Reconstruction Case in Cipto Mangunkusumo Hospital in Jakarta With 24 Patient as Subject Who Will Divide Into 2 Group.
Official Title
Comparison of the Functional Outcome of Site Peroneus Longus Graft Donors With and Without Distal Stump Suturing of Peroneus Tendon Brevis on ACL Reconstruction Case .
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

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
Yes

5. Study Description

Brief Summary
Injury of the Anterior Cruciate Ligament (ACL) is one of the most common sports injuries. The incidence rate reaches 68.6 cases per 100,000 people per year. Management of ACL injuries for individuals who want to return to the level of exercise activity as before, mostly in the form of reconstructive surgery. As many as 60,000 to 175,000 cases of ACL reconstruction per year are carried out in the United States At present, many reconstructive surgeries are performed by taking tendon grafts on the patient's own body (autograft) to then be used instead of the ACL. The most widely used graft sources are Hamstring and Bone-Patellar Tendon-Bone (BPTB) grafts. Other alternative grafts are Quadriceps tendon, Fascia Lata, Iliotibial Band, and Peroneus Longus Tendon. Each graft retrieval technique has advantages and disadvantages. BPTB graft has the best tensile strength and bone union with bone, but the complications of anterior knee pain are also quite common (5-55%). Hamstring grafts and Quadriceps grafts minimize the complications of anterior knee pain, with fairly good tensile strength, but the union of grafts with bone takes longer. The loss of Hamstring tendons also causes a decrease in muscle strength in Hamstring, where Hamstring has an important role in preventing the anterior translation of the tibia Peroneus Longus Tendon graft is an alternative graft developed to minimize complications associated with graft use from the area around the knee. Peroneus Longus tendons also have tensile strength similar to Hamstring tendons. As with other graft extracts, Peroneus Longus tendon graft is also accompanied by complications in the donor site. Possible complications arising from the loss of the Peroneus Longus tendon include ankle instability and decreased flexion strength of the 1st ray and ankle eversion. Research carried out by Bancha et al showed a reduction in flexion strength of 1st ray and ankle eversion significantly, without any instability in the ankle. Peroneus longus provides 5.5% strength for moderate dorsiflexion for ankle eversion movements, peroneus longus is the main muscle. But in other studies it is said that the use of peroneus longus graft does not interfere with the stability of the ankle and ROM. Does not even affect the functional outcome of the ankle However, in a study conducted by Bancha et al and Kerimoglu et al., The technique used for taking Peroneus Longus graft tendons did not include suturing in the distal stump of Peroneous Longus. So with this study, researchers wanted to find out whether different results would be found related to donor site complications if the technique used included suturing the distal stump of the Peroneus Longus tendon against the peroneus brevis tendon

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament
Keywords
ACL, Rupture of ACL, Donor site, Peroneus Longus Graft, Distal Stump, Peroneus Brevis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sutured Stump
Arm Type
Experimental
Arm Description
The group consist of subject with distal stump suturing of perobeus longus agains peroneus brevis in ACL Reconstruction Case
Arm Title
Unsutured Stump
Arm Type
No Intervention
Arm Description
The group consist of subject without distal stump suturing of peroneus longus agains peroneus brevis in ACL Reconstruction Case
Intervention Type
Procedure
Intervention Name(s)
Distal Stump Suturing
Intervention Description
in ACL Reconstruction case , Group A consist of subject with operation procedure suturing the distal stump peroneus longus against the peroneus brevis in ACL reconstruction using the peroneus longus autograft.
Primary Outcome Measure Information:
Title
Preoperative hand dynamometer value
Description
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Time Frame
This measurement was carried out at the preoperative setting
Title
Three-months postoperative hand dynamometer value
Description
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Time Frame
This measurement was carried out at 3 months postoperatively
Title
Six-months postoperative hand dynamometer value
Description
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Time Frame
This measurement was carried out at 6 months postoperatively
Title
Preoperative Clark's Angle Value
Description
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Time Frame
This measurement was carried out at the preoperative setting
Title
Three-months Clark's Angle Value
Description
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Time Frame
This measurement was carried out at the 3 months postoperatively
Title
Six-months Clark's Angle Value
Description
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Time Frame
This measurement was carried out at the 6 months postoperatively
Title
Preoperative the American Orthopedic Foot and Ankle Score (AOFAS)
Description
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Time Frame
Examination carried out 4 times for each patient in preoperative setting
Title
Three months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)
Description
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Time Frame
Examination carried out 4 times for each patient in 3 months postoperatively
Title
Six months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)
Description
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Time Frame
Examination carried out 4 times for each patient in 6 months postoperatively
Title
Preoperative visual analogue scale foot and ankle (VAS-FA)
Description
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. VAS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Time Frame
Examination carried out 4 times for each patient at preoperative setting
Title
Three-months postoperative visual analogue scale foot and ankle (VAS-FA)
Description
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Time Frame
Examination carried out 4 times for each patient at 3 months postoperatively
Title
Six-months postoperative visual analogue scale foot and ankle (VAS-FA)
Description
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Time Frame
Examination carried out 4 times for each patient at 6 months postoperatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with total ACL rupture using peroneus longus graft The suturing procedure for the distal stump peroneus longus against the peroneus brevis tendon is performed by orthopedic specialists or resident chiefs who have been given training in advance. Exclusion Criteria: Osteoarthtis Knee Kellgren-Lawrence III and IV Osteoarthtis Knee Kellgren-Lawrence III and IV Flatfoot as evidenced by physical examination and footprinting
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
14250
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Learn more about this trial

Comparison of the Functional Outcome of Site Peroneus Longus Graft Donors With and Without Distal Stump Suturing of Peroneus Tendon Brevis on ACL Reconstruction Case in Cipto Mangunkusumo Hospital in Jakarta With 24 Patient as Subject Who Will Divide Into 2 Group.

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