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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Procedure: Patella tendon & bone block autograft + press-fit femoral technique
* Procedure: Arthroscopic ACL reconstruction
* Device: Hamstring tendon autograft + implant fixation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: implantless Arthroscopic ACL reconstruction<br>implantless Arthroscopic ACL reconstruction using press-fit femoral technique | Procedure: Patella tendon & bone block autograft + press-fit femoral technique<br>* 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.<br>Procedure: Arthroscopic ACL reconstruction<br>* Arthroscopic ACL reconstruction with implant (using hamstring autograft fixed with bioscrew and endo-button)<br>|
| Experimental: Arthroscopic ACL reconstruction with implant<br>ACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button) | Procedure: Arthroscopic ACL reconstruction<br>* Arthroscopic ACL reconstruction with implant (using hamstring autograft fixed with bioscrew and endo-button)<br>Device: Hamstring tendon autograft + implant fixation<br>* Arthroscopic ACL reconstruction with implant (using hamstring tendon autograft fixed with bioscrew and endo-button)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior knee laxity | 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. | At 1 month after surgery. | 
| Anterior knee laxity | 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. | At 3 months after surgery. | 
| Anterior knee laxity | 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. | At 6 months after surgery. | 
| Functional outcome score International Knee Documentation committee (IKDC) | 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. | At 1 month after surgery. | 
| Functional outcome score International Knee Documentation committee (IKDC) | 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. | At 3 months after surgery. | 
| Functional outcome score International Knee Documentation committee (IKDC) | 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. | At 6 months after surgery. | 
| Functional outcome score Tegner-Lysholm | 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: limp (0, 3, 5) support (0, 2, 5) locking (0, 2, 6, 10, 15) instability (0, 5, 10, 15, 20, 25) pain (0, 5, 10, 15, 20, 25) swelling (0, 2, 6, 10) stair climbing (0, 2, 6, 10) 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. | At 1 month after surgery. | 
| Functional outcome scores Tegner-Lysholm | 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: limp (0, 3, 5) support (0, 2, 5) locking (0, 2, 6, 10, 15) instability (0, 5, 10, 15, 20, 25) pain (0, 5, 10, 15, 20, 25) swelling (0, 2, 6, 10) stair climbing (0, 2, 6, 10) 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. | At 3 months after surgery. | 
| Functional outcome scores Tegner-Lysholm | 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: limp (0, 3, 5) support (0, 2, 5) locking (0, 2, 6, 10, 15) instability (0, 5, 10, 15, 20, 25) pain (0, 5, 10, 15, 20, 25) swelling (0, 2, 6, 10) stair climbing (0, 2, 6, 10) 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. | At 6 months after surgery. | 
| Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS) | 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. | At 1 month after surgery. | 
| Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS) | 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. | At 3 months after surgery. | 
| Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS) | 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. | At 6 months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior cruciate ligament, anterior cruciate ligament injury, implantless ACL reconstruction, press-fit fixation