CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Patella tendon & bone block autograft + press-fit femoral technique +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04123834
NCT04123834Phase 2Completed
CompareCT.gov

Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autografts Using Press-Fit Fixation Technique and Hamstring Autografts Using Implant in Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective Study

Indonesia University·interventional·Posted Oct 11, 2019·Updated Oct 11, 2019

In Brief

A Phase 2 clinical trial evaluating Patella tendon & bone block autograft + press-fit femoral technique, Arthroscopic ACL reconstruction, and 1 other intervention for Anterior Cruciate Ligament Injuries and 2 related conditions. Completed, enrolled 32 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnterior Cruciate Ligament Injuries, Ligament; Rupture, Knee, Spontaneous, Tendon Graft; Complication, Mechanical
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 11, 2019
Enrollment StartMar 1, 2013
Primary CompletionMar 30, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.7 years ago

Interventions

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

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.

Arthroscopic ACL reconstructionprocedure

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

Hamstring tendon autograft + implant fixationdevice

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