Back to resultsFunctional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autograft in Arthroscopic ACL Reconstruction
Primary Purpose
Anterior Cruciate Ligament Injuries, Ligament; Rupture, Knee, Spontaneous, Tendon Graft; Complication, Mechanical
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Patella tendon & bone block autograft + press-fit femoral technique
Arthroscopic ACL reconstruction
Hamstring tendon autograft + implant fixation
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring anterior cruciate ligament, anterior cruciate ligament injury, implantless ACL reconstruction, press-fit fixation
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
implantless Arthroscopic ACL reconstruction
Arthroscopic ACL reconstruction with implant
Arm Description
implantless Arthroscopic ACL reconstruction using press-fit femoral technique
ACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button)
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04123834
First Posted
September 29, 2019
Last Updated
October 9, 2019
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT04123834
Brief Title
Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autograft in Arthroscopic ACL Reconstruction
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
March 30, 2014 (Actual)
Study Completion Date
March 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Ligament; Rupture, Knee, Spontaneous, Tendon Graft; Complication, Mechanical
Keywords
anterior cruciate ligament, anterior cruciate ligament injury, implantless ACL reconstruction, press-fit fixation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
implantless Arthroscopic ACL reconstruction
Arm Type
Experimental
Arm Description
implantless Arthroscopic ACL reconstruction using press-fit femoral technique
Arm Title
Arthroscopic ACL reconstruction with implant
Arm Type
Experimental
Arm Description
ACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button)
Intervention Type
Procedure
Intervention Name(s)
Patella tendon & bone block autograft + press-fit femoral technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic ACL reconstruction
Intervention Description
Arthroscopic ACL reconstruction with implant (using hamstring autograft fixed with bioscrew and endo-button)
Intervention Type
Device
Intervention Name(s)
Hamstring tendon autograft + implant fixation
Intervention Description
Arthroscopic ACL reconstruction with implant (using hamstring tendon autograft fixed with bioscrew and endo-button)
Primary Outcome Measure Information:
Title
Anterior knee laxity
Description
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.
Time Frame
At 1 month after surgery.
Title
Anterior knee laxity
Description
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.
Time Frame
At 3 months after surgery.
Title
Anterior knee laxity
Description
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.
Time Frame
At 6 months after surgery.
Title
Functional outcome score International Knee Documentation committee (IKDC)
Description
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.
Time Frame
At 1 month after surgery.
Title
Functional outcome score International Knee Documentation committee (IKDC)
Description
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.
Time Frame
At 3 months after surgery.
Title
Functional outcome score International Knee Documentation committee (IKDC)
Description
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.
Time Frame
At 6 months after surgery.
Title
Functional outcome score Tegner-Lysholm
Description
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.
Time Frame
At 1 month after surgery.
Title
Functional outcome scores Tegner-Lysholm
Description
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.
Time Frame
At 3 months after surgery.
Title
Functional outcome scores Tegner-Lysholm
Description
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.
Time Frame
At 6 months after surgery.
Title
Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
Description
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.
Time Frame
At 1 month after surgery.
Title
Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
Description
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.
Time Frame
At 3 months after surgery.
Title
Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)
Description
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.
Time Frame
At 6 months after surgery.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andri MT Lubis, MD, PhD
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autograft in Arthroscopic ACL Reconstruction
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