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

University Hospital Basel

Status

Completed

Conditions

Injury of the Anterior Cruciate Ligament (ACL)

Treatments

Other: collection of Patient Reported Outcome (PRO) data

Other: collection of anthropometric and clinical functional data

Other: gait analysis

Study type

Observational

Funder types

Other

Identifiers

NCT04429165

2020-00551 ch20Rikli;

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients: 2 years since ACL reconstruction with autologous hamstring tendon
Control subjects: no previous injury to the meniscus or the ligament apparatus of the knee

Exclusion criteria

BMI > 35 kg / m2
neuromuscular diseases that affect lower limb movement
Inability to give informed consent
Patients: previous injury or surgical treatment of the opposite side within the past 2 years and the injured leg within the past 6 months; other pathologies that affect the mobility of the knee