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

NCT04123834 | Completed Phase 1

• 1 other identifier: Press-Fit ACL
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  At 6 months after surgery.

Study Arms (2)

implantless Arthroscopic ACL reconstruction

EXPERIMENTAL

implantless Arthroscopic ACL reconstruction using press-fit femoral technique

Procedure: Patella tendon & bone block autograft + press-fit femoral technique; Procedure: Arthroscopic ACL reconstruction

Arthroscopic ACL reconstruction with implant

EXPERIMENTAL

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

Procedure: Arthroscopic ACL reconstruction; Device: Hamstring tendon autograft + implant fixation

Interventions

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.

implantless Arthroscopic ACL reconstruction

Arthroscopic ACL reconstruction PROCEDURE

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

Arthroscopic ACL reconstruction with implant; implantless Arthroscopic ACL reconstruction

Hamstring tendon autograft + implant fixation DEVICE

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

Arthroscopic ACL reconstruction with implant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• total rupture of ACL on a single knee

You may not qualify if:

• increased knee laxity according to Beighton Hypermobility Score
• previous history of knee surgery

Sponsors & Collaborators

• Indonesia University: lead

Related Publications (11)

• Biau DJ, Tournoux C, Katsahian S, Schranz PJ, Nizard RS. Bone-patellar tendon-bone autografts versus hamstring autografts for reconstruction of anterior cruciate ligament: meta-analysis. BMJ. 2006 Apr 29;332(7548):995-1001. doi: 10.1136/bmj.38784.384109.2F. Epub 2006 Apr 7.

  PMID: 16603564 BACKGROUND

• Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.

  PMID: 20660401 BACKGROUND

• Romanini E, D'Angelo F, De Masi S, Adriani E, Magaletti M, Lacorte E, Laricchiuta P, Sagliocca L, Morciano C, Mele A. Graft selection in arthroscopic anterior cruciate ligament reconstruction. J Orthop Traumatol. 2010 Dec;11(4):211-9. doi: 10.1007/s10195-010-0124-9. Epub 2010 Dec 23.

  PMID: 21181226 BACKGROUND

• Remer EM, Fitzgerald SW, Friedman H, Rogers LF, Hendrix RW, Schafer MF. Anterior cruciate ligament injury: MR imaging diagnosis and patterns of injury. Radiographics. 1992 Sep;12(5):901-15. doi: 10.1148/radiographics.12.5.1529133.

  PMID: 1529133 BACKGROUND

• Tirmik U, Mahirogullari M, Kuskucu M. The results of reconstruction of the ACL using the cross-pin femoral system and four-strand hamstring tendon autografts. Acta Orthop Traumatol Turc. 2011;45(4):233-9. doi: 10.3944/AOTT.2011.2309.

  PMID: 21908962 BACKGROUND

• Mei Y, Ao YF, Wang JQ, Ma Y, Zhang X, Wang JN, Zhu JX. Clinical characteristics of 4355 patients with anterior cruciate ligament injury. Chin Med J (Engl). 2013 Dec;126(23):4487-92.

  PMID: 24286412 BACKGROUND

• Taketomi S, Inui H, Yamagami R, Shirakawa N, Kawaguchi K, Nakagawa T, Tanaka S. Bone-Patellar Tendon-Bone Autograft versus Hamstring Tendon Autograft for Anatomical Anterior Cruciate Ligament Reconstruction with Three-Dimensional Validation of Femoral and Tibial Tunnel Positions. J Knee Surg. 2018 Oct;31(9):866-874. doi: 10.1055/s-0037-1615813. Epub 2017 Dec 28.

  PMID: 29284176 BACKGROUND

• Pavlik A, Hidas P, Tallay A, Toman J, Berkes I. Femoral press-fit fixation technique in anterior cruciate ligament reconstruction using bone-patellar tendon-bone graft: a prospective clinical evaluation of 285 patients. Am J Sports Med. 2006 Feb;34(2):220-5. doi: 10.1177/0363546505279920. Epub 2005 Oct 6.

  PMID: 16210575 BACKGROUND

• Noyes FR, Barber-Westin SD. Treatment of meniscus tears during anterior cruciate ligament reconstruction. Arthroscopy. 2012 Jan;28(1):123-30. doi: 10.1016/j.arthro.2011.08.292. Epub 2011 Nov 9.

  PMID: 22074619 BACKGROUND

• Widuchowski W, Widuchowska M, Koczy B, Dragan S, Czamara A, Tomaszewski W, Widuchowski J. Femoral press-fit fixation in ACL reconstruction using bone-patellar tendon-bone autograft: results at 15 years follow-up. BMC Musculoskelet Disord. 2012 Jun 27;13:115. doi: 10.1186/1471-2474-13-115.

  PMID: 22738187 BACKGROUND

• Wipfler B, Donner S, Zechmann CM, Springer J, Siebold R, Paessler HH. Anterior cruciate ligament reconstruction using patellar tendon versus hamstring tendon: a prospective comparative study with 9-year follow-up. Arthroscopy. 2011 May;27(5):653-65. doi: 10.1016/j.arthro.2011.01.015.

  PMID: 21663722 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Rupture

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Andri MT Lubis, MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: September 29, 2019
• First Posted: October 11, 2019
• Study Start: March 1, 2013
• Primary Completion: March 30, 2014
• Study Completion: March 30, 2014
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share