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

University of Indonesia (UI)

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Procedure: Patella tendon & bone block autograft + press-fit femoral technique; Device: Hamstring tendon autograft + implant fixation; Procedure: Arthroscopic ACL reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04123834

Press-Fit ACL

Details and patient eligibility

About

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.

Full description

Purpose: 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.

Materials and Methods: A prospective cohort study design was used. Between March 2013 and March 2014, 12 patients underwent implantless ACL reconstruction using press-fit femoral technique, while 24 patients underwent implant ACL reconstruction. Objective functional outcome were measured using rolimeter, and subjective functional outcome were measured according to IKDC, Tegner-Lysholm and KOOS.

Enrollment: 32 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• total rupture of ACL on a single knee

Exclusion criteria

• increased knee laxity according to Beighton Hypermobility Score
• previous history of knee surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

implantless Arthroscopic ACL reconstruction

Experimental group

Description:

implantless Arthroscopic ACL reconstruction using press-fit femoral technique

Treatment:

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

Procedure: Arthroscopic ACL reconstruction

Arthroscopic ACL reconstruction with implant

Experimental group

Description:

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

Treatment:

Device: Hamstring tendon autograft + implant fixation

Procedure: Arthroscopic ACL reconstruction