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Completed

NCT Number: NCT04123834

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Ligament; Rupture, Knee, Spontaneous Rupture Tendon Graft; Complication, Mechanical Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

Arthroscopic ACL reconstruction

Procedure

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

Hamstring tendon autograft + implant fixation

Device

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

Primary outcomes

  1. Anterior knee laxity

    Time frame: At 1 month 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.

  2. Anterior knee laxity

    Time frame: At 3 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.

  3. Anterior knee laxity

    Time frame: 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.

  4. Functional outcome score International Knee Documentation committee (IKDC)

    Time frame: At 1 month 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.

  5. Functional outcome score International Knee Documentation committee (IKDC)

    Time frame: At 3 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.

  6. Functional outcome score International Knee Documentation committee (IKDC)

    Time frame: 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.

  7. Functional outcome score Tegner-Lysholm

    Time frame: 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:

    • 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.

  8. Functional outcome scores Tegner-Lysholm

    Time frame: At 3 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:

    • 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.

  9. Functional outcome scores Tegner-Lysholm

    Time frame: 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:

    • 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.

  10. Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)

    Time frame: At 1 month 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.

  11. Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)

    Time frame: At 3 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.

  12. Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 11, 2019
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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