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.

NCT ID: NCT04431063

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-06-30

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

Conditions

Rupture of Anterior Cruciate Ligament

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sutured Stump

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

Group Type: EXPERIMENTAL

Distal Stump Suturing

Intervention Type: 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.

Unsutured Stump

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Distal Stump Suturing

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.

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Andri Maruli Tua Lubis

Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

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Other Identifiers

18-10-1173

Identifier Type: -

Identifier Source: org_study_id