NCT04429165

Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction

RetroBRACE II: Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction - Considering Socioeconomic Aspects and Return to Work

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct comparison to ACL reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. In addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.

Detailed description

Injury of the anterior cruciate ligament (ACL) is one of the most common injuries of the knee. Since May 2016, patients with proximal ruptures of the ACL have been treated with direct repair and InternalBraceTM Ligament Augmentation at the University Hospital of Basel. The remodelling of hamstring grafts used for ACL reconstruction is completed at the earliest 2 years after the surgery. The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct comparison to ACL reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. In addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.

Conditions

• Injury of the Anterior Cruciate Ligament (ACL)

Interventions

Type	Name	Description
OTHER	collection of Patient Reported Outcome (PRO) data	collection of Patient Reported Outcome (PRO) data by questionnaires
OTHER	collection of anthropometric and clinical functional data	collection of anthropometric and clinical functional data including range of motion (ROM), isokinetic muscle strength, joint position sense, single leg balance ability, and muscle activity
OTHER	gait analysis	gait analysis in a motion capture volume on a walkway including force plates and on a treadmill with pressure plates, while 3D kinematics and kinetics, pressure and electromyographic (EMG) data will be recorded

Timeline

• Start date: 2020-04-23
• Primary completion: 2022-07-14
• Completion: 2022-07-14
• First posted: 2020-06-12
• Last updated: 2023-01-19

Locations

1 site across 1 country: Switzerland