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

Phase 1

Completed

• Conditions: Anterior Cruciate Ligament Injuries; Ligament; Rupture, Knee, Spontaneous; Tendon Graft; Complication, Mechanical
• Interventions: Procedure: Patella tendon & bone block autograft + press-fit femoral technique; Procedure: Arthroscopic ACL reconstruction; Device: Hamstring tendon autograft + implant fixation

• Registration Number: NCT04123834
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2013-03-01
• Primary Completion: 2014-03-30
• Study Completion: 2014-03-30
• Study First Submitted: 2019-09-29
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-11
• Last Update Posted: 2019-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
implantless Arthroscopic ACL reconstruction	Arthroscopic ACL reconstruction	implantless Arthroscopic ACL reconstruction using press-fit femoral technique
Arthroscopic ACL reconstruction with implant	Hamstring tendon autograft + implant fixation	ACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button)
implantless Arthroscopic ACL reconstruction	Patella tendon & bone block autograft + press-fit femoral technique	implantless Arthroscopic ACL reconstruction using press-fit femoral technique
Arthroscopic ACL reconstruction with implant	Arthroscopic ACL reconstruction	ACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button)

Primary Outcome Measures

Name	Time	Method
Functional outcome score Tegner-Lysholm	At 1 month after surgery.	Tegner-Lysholm Score subjectively evaluate to how the knee pain has affected the ability to manage in everyday life.; Number of items: 8 items, each scored differently; Subscales: 1. limp (0, 3, 5); 2. support (0, 2, 5); 3. locking (0, 2, 6, 10, 15); 4. instability (0, 5, 10, 15, 20, 25); 5. pain (0, 5, 10, 15, 20, 25); 6. swelling (0, 2, 6, 10); 7. stair climbing (0, 2, 6, 10); 8. squatting (0, 2, 4, 5); Total score is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points.
Anterior knee laxity	At 6 months after surgery.	Anterior knee laxity (in centimetres) was assessed by measuring anterior translation at 30° of flexion with a rolimeter and comparing it with the contralateral knee.
Functional outcome scores Tegner-Lysholm	At 6 months after surgery.	Tegner-Lysholm Score subjectively evaluate to how the knee pain has affected the ability to manage in everyday life.; Number of items: 8 items, each scored differently; Subscales: 1. limp (0, 3, 5); 2. support (0, 2, 5); 3. locking (0, 2, 6, 10, 15); 4. instability (0, 5, 10, 15, 20, 25); 5. pain (0, 5, 10, 15, 20, 25); 6. swelling (0, 2, 6, 10); 7. stair climbing (0, 2, 6, 10); 8. squatting (0, 2, 4, 5); Total score is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points.
Functional outcome score International Knee Documentation committee (IKDC)	At 6 months after surgery.	International Knee Documentation committee (IKDC) score evaluate improvement or deterioration in symptoms, function, and sports activities.; Number of items: 18 subscales: * symptoms: pain, stiffness, swelling, locking/catching and giving-way of the knee.; * sports activities: functions such as going up and down the stairs, rising from a chair, squatting and jumping; * function and activity of daily living: knee condition prior to injury; Response options vary for each item. Item 6 dichotomizes response into yes/no; items 1, 4, 5, 7, 8, and 9 use 5-point Likert scales; and items 2, 3, and 10 use 11-point numerical rating scales. The total score is calculated as (sum of items)/(maximum possible score) × 100. Possible score range 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. Higher values represent a better outcome.
Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)	At 6 months after surgery.	Knee Injury and Osteoarthritis Outcome (KOOS) measure patients' opinions about their knee and associated problems over short- and long-term followup (1 week to decades).; Number of items: 42 items rated on a 5-point Likert scale (0-4) across 5 subscales: * pain frequency and severity during functional activities (subscale score range: 0-36); * symptoms such as the severity of knee stiffness and the presence of swelling, grinding or clicking, catching, and range of motion restriction (subscale score range: 0-28); * difficulty experienced during activities of daily living (ADL) (subscale score range: 0-68); * difficulty experienced with sport and recreational activities (subscale score range: 0-20); * knee-related quality of life (QOL) (subscale score range: 0-16); The 5 dimensions are scored separately as the sum of all corresponding items, and then converted into percentage (score range 0-100). Score of 0 means extreme knee problems and score of 100 means no knee problems.