A Phase 1/2 interventional study of Patella tendon & bone block autograft + press-fit femoral technique and Arthroscopic ACL reconstruction in Anterior Cruciate Ligament Injuries, Ligament; Rupture, Knee, Spontaneous and Tendon Graft; Complication, Mechanical, sponsored by Indonesia University. Completed. Per ClinicalTrials.gov, last updated 2019-10-11.
Sponsored by Indonesia University · Phase 1/2, Interventional, and Treatment
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.
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.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's enrollment of 32 is below the median of 72 across 334 interventional studies indexed under Rupture.
Browse Rupture studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
implantless Arthroscopic ACL reconstruction using press-fit femoral technique
Procedure: Patella tendon & bone block autograft + press-fit femoral technique · Procedure: Arthroscopic ACL reconstruction
ACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button)
Procedure: Arthroscopic ACL reconstruction · Device: Hamstring tendon autograft + implant fixation
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 with implant (using hamstring autograft fixed with bioscrew and endo-button)
Arthroscopic ACL reconstruction with implant (using hamstring tendon autograft fixed with bioscrew and endo-button)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: 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.
Time frame: 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: 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.
Time frame: 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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 6 months after surgery.
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Indonesia University