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

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ClinicalTrials.gov Identifier: NCT04123834
Recruitment Status : Completed
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Andri Maruli Tua Lubis, 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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injuries Ligament; Rupture, Knee, Spontaneous Tendon Graft; Complication, Mechanical Procedure: Patella tendon & bone block autograft + press-fit femoral technique Procedure: Arthroscopic ACL reconstruction Device: Hamstring tendon autograft + implant fixation Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2013
Actual Primary Completion Date : March 30, 2014
Actual Study Completion Date : March 30, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: implantless Arthroscopic ACL reconstruction
implantless Arthroscopic ACL reconstruction using press-fit femoral technique
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)

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




Primary Outcome Measures :
  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:

    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.


  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:

    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.


  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:

    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.


  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123834


Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Andri MT Lubis, MD, PhD Indonesia University
  Study Documents (Full-Text)

Documents provided by Andri Maruli Tua Lubis, Indonesia University:
Informed Consent Form  [PDF] March 1, 2013

Publications:

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Responsible Party: Andri Maruli Tua Lubis, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04123834    
Other Study ID Numbers: Press-Fit ACL
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andri Maruli Tua Lubis, Indonesia University:
anterior cruciate ligament
anterior cruciate ligament injury
implantless ACL reconstruction
press-fit fixation
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries