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NCT Number: NCT04431063

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.

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

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Key information

Conditions

Rupture of Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 14250, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distal Stump Suturing

Procedure

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 outcomes

  1. Preoperative hand dynamometer value

    Time frame: This measurement was carried out at the preoperative setting

    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

  2. Three-months postoperative hand dynamometer value

    Time frame: This measurement was carried out at 3 months postoperatively

    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

  3. Six-months postoperative hand dynamometer value

    Time frame: This measurement was carried out at 6 months postoperatively

    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

  4. Preoperative Clark's Angle Value

    Time frame: This measurement was carried out at the preoperative setting

    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

  5. Three-months Clark's Angle Value

    Time frame: This measurement was carried out at the 3 months postoperatively

    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

  6. Six-months Clark's Angle Value

    Time frame: This measurement was carried out at the 6 months postoperatively

    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

  7. Preoperative the American Orthopedic Foot and Ankle Score (AOFAS)

    Time frame: Examination carried out 4 times for each patient in preoperative setting

    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

  8. Three months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)

    Time frame: Examination carried out 4 times for each patient in 3 months postoperatively

    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

  9. Six months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)

    Time frame: Examination carried out 4 times for each patient in 6 months postoperatively

    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

  10. Preoperative visual analogue scale foot and ankle (VAS-FA)

    Time frame: Examination carried out 4 times for each patient at preoperative setting

    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

  11. Three-months postoperative visual analogue scale foot and ankle (VAS-FA)

    Time frame: Examination carried out 4 times for each patient at 3 months postoperatively

    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

  12. Six-months postoperative visual analogue scale foot and ankle (VAS-FA)

    Time frame: Examination carried out 4 times for each patient at 6 months postoperatively

    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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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 .

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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