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

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550299
• Other study ID #: 022
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2013
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2020
• Source: Vita Care
• Contact: Instituto Vita
• Email: institutovita[@]institutovita.org.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• ACL Tear
• Anterior Cruciate Ligament Injuries
• Athletic Injuries
• Knee Injuries
• Sports Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto Vita	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Vita Care	Johnson & Johnson

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone-graft integration	Bone-graft integration assessed in the MRI	4-6 months
Secondary	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)	4-12 months
Secondary	Retear	Retear of the reconstructed ACL	Through study completion, an average of 2 years