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Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autograft in Arthroscopic ACL Reconstruction

NCT04123834 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-10-11

No results posted yet for this study

Summary

The use of implants for conventional anterior cruciate ligament (ACL) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. Implantless ACL surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. The investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant.

Conditions

  • Anterior Cruciate Ligament Injuries
  • Ligament; Rupture, Knee, Spontaneous
  • Tendon Graft; Complication, Mechanical

Interventions

PROCEDURE

Patella tendon & bone block autograft + press-fit femoral technique

Implantless Arthroscopic ACL reconstruction using press-fit femoral technique The investigator's study uses the press-fit graft fixation technique by Edgar Michael. A midline skin incision was made that extends from inferior pole of patella up to anterior tibial tuberosity. Patella tendon with tibial tuberosity bone block were harvested, patella bone was left intact. The tendon was fixed together with non-absorbable suture.

PROCEDURE

Arthroscopic ACL reconstruction

Arthroscopic ACL reconstruction with implant (using hamstring autograft fixed with bioscrew and endo-button)

DEVICE

Hamstring tendon autograft + implant fixation

Arthroscopic ACL reconstruction with implant (using hamstring tendon autograft fixed with bioscrew and endo-button)

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Andri MT Lubis, MD, PhD · Indonesia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-01
Primary Completion
2014-03-30
Completion
2014-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123834 on ClinicalTrials.gov