Clinical trial NCT04123834: Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autograft in Arthroscopic ACL Reconstruction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anterior Cruciate Ligament Injuries
Ligament; Rupture, Knee, Spontaneous
Tendon Graft; Complication, Mechanical
Keywords: anterior cruciate ligament
anterior cruciate ligament injury
implantless ACL reconstruction
press-fit fixation
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anterior knee laxity
timeFrame: At 1 month after surgery.
measure: Anterior knee laxity
timeFrame: At 3 months after surgery.
measure: Anterior knee laxity
timeFrame: At 6 months after surgery.
measure: Functional outcome score International Knee Documentation committee (IKDC)
timeFrame: At 1 month after surgery.
measure: Functional outcome score International Knee Documentation committee (IKDC)
timeFrame: At 3 months after surgery.
measure: Functional outcome score International Knee Documentation committee (IKDC)
timeFrame: At 6 months after surgery.
measure: Functional outcome score Tegner-Lysholm
timeFrame: At 1 month after surgery.
measure: Functional outcome scores Tegner-Lysholm
timeFrame: At 3 months after surgery.
measure: Functional outcome scores Tegner-Lysholm
timeFrame: At 6 months after surgery.
measure: Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
timeFrame: At 1 month after surgery.
measure: Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
timeFrame: At 3 months after surgery.
measure: Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
timeFrame: At 6 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Indonesia University
name: Andri MT Lubis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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