The Effect of Fertilized ACL Technique on Outcomes of ACL Reconstruction in Young Adults

NCT04178538 | Unknown DMC

• 1 other identifier: 1455859
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective study, with outcomes including re-rupture rate and return to sport will be collected following ACL reconstruction. In keeping with the surgeon's standard practice, patients 24 years and under that are skeletally mature, will receive a quad tendon autograft; patients 25 years of age and over will receive an allograft All-Inside ACL reconstruction. These two cohorts will then be randomized into two groups, one with bone marrow/DBM and InternalBrace augmentation, and one without. The study procedures will involve use of x-rays, MRI, CT scan, and surveys at varying time points to assess radiographic, imaging and clinical outcomes.

Conditions

ACL Tear; ACL Injury; Arthroscopy; Anterior Cruciate Ligament Tear

Keywords

Anterior cruciate ligament tear; ACL

Outcome Measures

Primary Outcomes (11)

• Changes in X rays

  AP and lateral radiographs of all patients included in the study will be obtained and assessed for changes over the study duration at specified time periods

  6 months, 1 year, and 2 years

• Changes in International Knee Documentation score

  Measures 3 categories: symptoms, sports activity, and knee function with a sum total 0-100 with 100 score having highest functional state and 0 low functioning.

  Pre-Op, 2 weeks, 6 weeks, 12 weeks, 6 months, 1 and 2 years post-operatively

• Changes in Visual analog pain scale

  High score 10 means high pain, low score 1 means low pain

  Pre-Op, 2 weeks, 6 weeks, 12 weeks, 6 months, 1 and 2 years post-operatively

• Change in Knee Injury and Osteoarthritis Outcome (KOOS) Scores

  five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems

  6 months, 1 and 2 years post-operatively

• Change in THE VETERANS RAND 12 ITEM HEALTH SURVEY

  patient-reported global health measure that is used to assess a patient's overall perspective of their health. seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents physical and psychological health status. results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points.

  6 months, 1 and 2 years post-operatively

• Change in LYSHOLM KNEE QUESTIONNAIRE

  patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).

  6 months, 1 and 2 years post-operatively

• Change in MARX ACTIVITY SCALE FORM

  MARX focuses on four activity points: running, deceleration, cutting (changing directions while running), and pivoting. Patients are asked to indicate approximately how many times in the past 12 months they performed each of these activities while at their healthiest and most active state. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a maximum of 16 points with a higher score indicating more frequent participation.

  6 months, 1 and 2 years post-operatively

• Return to play

  We will assess the time it takes from date of ACl reconstruction until the patient returs to sporting activiy

  Until study completion, average of 1 year

• graft re-rupture rate

  We will assess patients for incidence of graft rerupture rate during rehab or after return to play

  Until study completion, average of 1 year

• MRI

  MIR scans will be performed first 6 patients in each group will receive MRIs of the knee to visualize graft maturation.

  12 weeks post op

• CT scan of operative knee

  At six (6) months, the first 6 patients in each group will receive CT scans of the knee to assess tunnel widening

  6 months post op

Study Arms (4)

25 years and older- ACL recon with DBM, Internal brace

EXPERIMENTAL

Patients in this arm will be 25 years of age and over and receive ACL reconstruction augmented with demineralized bone matrix, bone marrow, and internal brace

Procedure: ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation

25 years and older- Standard ACL reconstruction

ACTIVE COMPARATOR

Patients in this arm will be 25 years of age and over will receive an allograft All-Inside ACL reconstruction

Procedure: Standard ACL reconstruction with all inside technique

24 years and younger- ACL recon with DBM, Internal brace

EXPERIMENTAL

In this arm patients 24 years and under that are skeletally mature, will receive ACL reconstruction with a quad tendon autograft augmented with demineralized bone matrix, bone marrow, and internal brace

Procedure: ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation

24 years and younger- Standard ACL reconstruction

ACTIVE COMPARATOR

In this arm patients 24 years and under that are skeletally mature, will receive ACL reconstruction with a quad tendon autograft standard all inside technique

Procedure: Standard ACL reconstruction with all inside technique

Interventions

ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation PROCEDURE

ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation with all inside technique

24 years and younger- ACL recon with DBM, Internal brace; 25 years and older- ACL recon with DBM, Internal brace

Standard ACL reconstruction with all inside technique PROCEDURE

Standard ACL reconstruction with all inside technique

24 years and younger- Standard ACL reconstruction; 25 years and older- Standard ACL reconstruction

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must be age 14-60 years old.
• Must be skeletally mature (Tanner 4) patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft or allograft augmentation.

You may not qualify if:

• An understanding of the purpose of the study, and have signed the informed consent.
• Able to return for all subsequent study visits
• Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction),
• Patients whom have had previous ACL reconstructive surgery on ipsilateral knee.
• Patients who are currently pregnant or nursing.
• Patients who have a current infection at the operative site.
• Any condition or personal issue that the surgeon deems ineffective to the outcome of the study.
• Workmen's compensation cases

Sponsors & Collaborators

• Marshall University: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Marshall University Department of Orthopedics

Huntington, West Virginia, 25701-4021, United States

Location

Related Publications (5)

• Crawford SN, Waterman BR, Lubowitz JH. Long-term failure of anterior cruciate ligament reconstruction. Arthroscopy. 2013 Sep;29(9):1566-71. doi: 10.1016/j.arthro.2013.04.014. Epub 2013 Jun 29.

  PMID: 23820260 BACKGROUND

• Wiggins AJ, Grandhi RK, Schneider DK, Stanfield D, Webster KE, Myer GD. Risk of Secondary Injury in Younger Athletes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2016 Jul;44(7):1861-76. doi: 10.1177/0363546515621554. Epub 2016 Jan 15.

  PMID: 26772611 BACKGROUND

• Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct.

  PMID: 28224069 BACKGROUND

• Narbona-Carceles J, Vaquero J, Suarez-Sancho S, Forriol F, Fernandez-Santos ME. Bone marrow mesenchymal stem cell aspirates from alternative sources: is the knee as good as the iliac crest? Injury. 2014 Oct;45 Suppl 4:S42-7. doi: 10.1016/S0020-1383(14)70009-9.

  PMID: 25384474 BACKGROUND

• Oladeji LO, Stannard JP, Cook CR, Kfuri M, Crist BD, Smith MJ, Cook JL. Effects of Autogenous Bone Marrow Aspirate Concentrate on Radiographic Integration of Femoral Condylar Osteochondral Allografts. Am J Sports Med. 2017 Oct;45(12):2797-2803. doi: 10.1177/0363546517715725. Epub 2017 Jul 24.

  PMID: 28737949 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Chad Lavender, MD

  Marshall University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: November 26, 2019
• Study Start: December 1, 2019
• Primary Completion: November 11, 2023
• Study Completion: November 11, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)