ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
Results of the Anterior Cruciate Ligament Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
Study Overview
Status
Conditions
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Instituto Vita
- Email: institutovita@institutovita.org.br
Study Contact Backup
- Name: Wagner Castropil
- Email: castropil@institutovita.com.br
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil, 01239-040
- Recruiting
- Instituto Vita
-
Contact:
- Wagner Castropil, PhD
- Email: castropil@institutovita.com.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
single bundle technique with the use of bioabsorbable implants
|
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
|
|
Active Comparator: Group B
single bundle technique with the use of Bio-Intrafix
|
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
|
|
Active Comparator: Group C
double bundle technique with the use of bioabsorbable implants
|
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
|
|
Active Comparator: Group D
double bundle technique with the use of Bio-Intrafix
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone-graft integration
Time Frame: 4-6 months
|
Bone-graft integration assessed in the MRI
|
4-6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical scores
Time Frame: 4-12 months
|
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)
|
4-12 months
|
|
Retear
Time Frame: Through study completion, an average of 2 years
|
Retear of the reconstructed ACL
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wagner Castropil, Instituto Vita
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 022 (ITCC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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