Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique

NCT ID: NCT03954925

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-01
• Study Completion Date: 2019-03-01

Brief Summary

this study was to evaluate the functional outcome of quadruple hamstring graft in femoral tunnel less than 15 mm and morethan or equal 15 mm of ACL reconstruction. The hypothesize that no difference intermediate follow up ( 6 month - 24 month) of functional outcome and clinical evaluation between short and normal femoral tunnel graft length of hamstring tendon ACL reconstruction.

Detailed Description

The patient recruitment (N=29) and baseline data collection were done at our institute between March2014-September 2015. The inclusion criteria were patients with anterior cruciate ligamentous injury who needed ligamentous reconstruction, closed growth plates and younger than 60 years old, absence of ligament injury to the opposite knee. The exclusion criteria are patients who did not want to participate in this study or patient with failed anterior cruciate ligamentous reconstruction.

All the procedure of anterior cruciate ligament reconstructions were performed by the senior authors (B.C). Semitendinosus and gracilis tendons were harvested through an oblique approach medial to the tibial tubercle in all patients. Complete anterior cruciate ligament was confirmed at arthroscopy. Associated intra-articular injuries such as meniscus tear and cartilage lesions were fixed at of the index operation .The femoral tunnel were drilled though the AM portal.

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anatomic anterior cruciate ligament with short hamstring

Anatomic anterior cruciate ligament with short hamstring graft

Group Type: ACTIVE_COMPARATOR

Anatomic anterior cruciate ligament with short hamstring graft technique

Intervention Type: PROCEDURE

ACL and short hamstring graft

Anatomic anterior cruciate ligament with standard hamstring

Anatomic anterior cruciate ligament with standard hamstring graft

Group Type: ACTIVE_COMPARATOR

Anatomic anterior cruciate ligament with a standard hamstring graft technique

Intervention Type: PROCEDURE

ACL with standard hamstring graft

Interventions

Anatomic anterior cruciate ligament with short hamstring graft technique

ACL and short hamstring graft

Intervention Type: PROCEDURE

Anatomic anterior cruciate ligament with a standard hamstring graft technique

ACL with standard hamstring graft

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with anterior cruciate ligamentous injury with the diagnosis of injured ligaments was made based on a detailed history of the knee injury, physical examination on pathologic status and abnormal laxity, routinely performed plain radiographs and MRI scans, and the findings at surgery.
• Patients who have closed growth plates.
• Patients who younger than 60 years old.
• Patients who absence of ligament injury to the opposite knee.

Exclusion Criteria

• Patients with a combined ligament injury as folling:

1. Posterior cruciate ligament

2. The lateral collateral ligament

3. The posterolateral corner structures of the knee

4. Medial collateral ligament.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thammasat University

OTHER

Sponsor Role: collaborator

Ramathibodi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jatupon Kongtharvonskul

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MTU-EC-OT-0-255-61

Identifier Type: -

Identifier Source: org_study_id