Trials / Completed
CompletedNCT04123834
Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autograft in Arthroscopic ACL Reconstruction
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Indonesia University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Anterior Cruciate Ligament Injuries
- Ligament; Rupture, Knee, Spontaneous
- Tendon Graft; Complication, Mechanical
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2014-03-30
- Completion
- 2014-03-30
- First posted
- 2019-10-11
- Last updated
- 2019-10-11
Source: ClinicalTrials.gov record NCT04123834. Inclusion in this directory is not an endorsement.