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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT04123834
Collaborator
(none)
32
2
12.9

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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.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 :
Mar 1, 2013
Actual Primary Completion Date :
Mar 30, 2014
Actual Study Completion Date :
Mar 30, 2014

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Anterior knee laxity [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 [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 [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) [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) [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) [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 [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 [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 [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Indonesia University

Investigators

  • Principal Investigator: Andri MT Lubis, MD, PhD, Indonesia University

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Andri Maruli Tua Lubis, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier:
NCT04123834
Other Study ID Numbers:
  • Press-Fit ACL
First Posted:
Oct 11, 2019
Last Update Posted:
Oct 11, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Principal Investigator, Indonesia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2019