ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation

Sponsor

Vita Care (Other)

Overall Status

Recruiting

CT.gov ID

NCT04550299

Collaborator

Johnson & Johnson (Industry)

112

Enrollment

Location

Arms

129.1

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Injuries ACL Tear ACL Injury Sports Injury	Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Results of the Anterior Cruciate Ligament Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation

Actual Study Start Date :

Feb 26, 2013

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A single bundle technique with the use of bioabsorbable implants	Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction 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	Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction 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	Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction 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	Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction 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

Outcome Measures

Primary Outcome Measures

Bone-graft integration [4-6 months]
Bone-graft integration assessed in the MRI

Secondary Outcome Measures

Clinical scores [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)
Retear [Through study completion, an average of 2 years]
Retear of the reconstructed ACL

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Vita	Sao Paulo	SP	Brazil	01239-040

Sponsors and Collaborators

Vita Care
Johnson & Johnson

Investigators

Principal Investigator: Wagner Castropil, Instituto Vita

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vita Care

ClinicalTrials.gov Identifier:

NCT04550299

Other Study ID Numbers:

First Posted:

Sep 16, 2020

Last Update Posted:

Sep 16, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Additional relevant MeSH terms:

Wounds and Injuries

Knee Injuries

Athletic Injuries

Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Sep 16, 2020