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

NCT04550299 | Unknown

• 1 other identifier: 022
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries; ACL Tear; ACL Injury; Sports Injury

Outcome Measures

Primary Outcomes (1)

• Bone-graft integration

  Bone-graft integration assessed in the MRI

  4-6 months

Secondary Outcomes (2)

• Clinical scores

  4-12 months

• Retear

  Through study completion, an average of 2 years

Study Arms (4)

Group A

ACTIVE COMPARATOR

single bundle technique with the use of bioabsorbable implants

Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction

Group B

ACTIVE COMPARATOR

single bundle technique with the use of Bio-Intrafix

Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction

Group C

ACTIVE COMPARATOR

double bundle technique with the use of bioabsorbable implants

Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction

Group D

ACTIVE COMPARATOR

double bundle technique with the use of Bio-Intrafix

Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction

Interventions

Surgical technique combined with a specific choice of the material for the ligament reconstruction OTHER

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

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vita Care: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Instituto Vita

São Paulo, São Paulo, 01239-040, Brazil

RECRUITING

MeSH Terms

Conditions

Knee Injuries; Anterior Cruciate Ligament Injuries; Athletic Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Wagner Castropil

  Instituto Vita

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Instituto Vita

CONTACT

institutovita@institutovita.org.br

Wagner Castropil

CONTACT

castropil@institutovita.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 16, 2020
• Study Start: February 26, 2013
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)