Back to resultsACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
Primary Purpose
Knee Injuries, ACL Tear, ACL Injury
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Surgical technique combined with a specific choice of the material for the ligament reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries
Eligibility Criteria
Inclusion Criteria:
isolated ACL injury for more than six weeks by physical examination and confirmed by magnetic resonance, adult non-elderly (18 to 60 years), nonobese (body mass index within the normal range)
Exclusion Criteria:
intraoperative complications requiring change in technique of reconstruction and / or anesthesia during surgery, patients undergoing cartilage piercing procedures ( such as microfractures) and / or meniscus suture, those with allergies to medications administered during anesthesia, surgery and / or post-operative patients with tourniquet time of more than two hours and patients who did not sign the consent form
Sites / Locations
- Instituto VitaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Group D
Arm Description
single bundle technique with the use of bioabsorbable implants
single bundle technique with the use of Bio-Intrafix
double bundle technique with the use of bioabsorbable implants
double bundle technique with the use of Bio-Intrafix
Outcomes
Primary Outcome Measures
Bone-graft integration
Bone-graft integration assessed in the MRI
Secondary Outcome Measures
Clinical scores
Knee laxity (KT1000, 0 to 5 mm range, higher scores = worse outcome), Objective and Subjective International Knee Documentation Committee (Objective IKDC: 0-100 range, higher scores = better outcomes; Subjective IKDC: A-D range; A = better outcomes) scores, Lysholm score (0-100 range, higher scores = better outcomes) and Tegner Activity Scale (0-10 range, higher scores = higher levels of physical activity/ competitive sport activity)
Retear
Retear of the reconstructed ACL
Full Information
NCT ID
NCT04550299
First Posted
September 1, 2020
Last Updated
September 8, 2020
Sponsor
Vita Care
Collaborators
Johnson & Johnson
1. Study Identification
Unique Protocol Identification Number
NCT04550299
Brief Title
ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
Official Title
Results of the Anterior Cruciate Ligament Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2013 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vita Care
Collaborators
Johnson & Johnson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.
Detailed Description
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.
This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant.
Primary outcome is graft ligamentization assessed in MRI images at 4-6 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, ACL Tear, ACL Injury, Sports Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
single bundle technique with the use of bioabsorbable implants
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
single bundle technique with the use of Bio-Intrafix
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
double bundle technique with the use of bioabsorbable implants
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
double bundle technique with the use of Bio-Intrafix
Intervention Type
Other
Intervention Name(s)
Surgical technique combined with a specific choice of the material for the ligament reconstruction
Intervention Description
The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice
Primary Outcome Measure Information:
Title
Bone-graft integration
Description
Bone-graft integration assessed in the MRI
Time Frame
4-6 months
Secondary Outcome Measure Information:
Title
Clinical scores
Description
Knee laxity (KT1000, 0 to 5 mm range, higher scores = worse outcome), Objective and Subjective International Knee Documentation Committee (Objective IKDC: 0-100 range, higher scores = better outcomes; Subjective IKDC: A-D range; A = better outcomes) scores, Lysholm score (0-100 range, higher scores = better outcomes) and Tegner Activity Scale (0-10 range, higher scores = higher levels of physical activity/ competitive sport activity)
Time Frame
4-12 months
Title
Retear
Description
Retear of the reconstructed ACL
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
isolated ACL injury for more than six weeks by physical examination and confirmed by magnetic resonance, adult non-elderly (18 to 60 years), nonobese (body mass index within the normal range)
Exclusion Criteria:
intraoperative complications requiring change in technique of reconstruction and / or anesthesia during surgery, patients undergoing cartilage piercing procedures ( such as microfractures) and / or meniscus suture, those with allergies to medications administered during anesthesia, surgery and / or post-operative patients with tourniquet time of more than two hours and patients who did not sign the consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Instituto Vita
Email
institutovita@institutovita.org.br
First Name & Middle Initial & Last Name or Official Title & Degree
Wagner Castropil
Email
castropil@institutovita.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wagner Castropil
Organizational Affiliation
Instituto Vita
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Vita
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01239-040
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wagner Castropil, PhD
Email
castropil@institutovita.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
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