Clinical trial NCT04429165: Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injury of the Anterior Cruciate Ligament (ACL)
Keywords: ACL rupture
primary ACL repair
ACL reconstruction using autologous hamstring tendons
InternalBraceTM Ligament Augmentation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent ACL reconstruction using an autologous hamstring tendon between 03/18 and 04/20 at University Hospital Basel.

30 age-matched control subjects without previous history of knee injury and/or surgery will be included for comparison.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Range of Motion (ROM) of the knee
timeFrame: at baseline (2 years after surgery)
measure: Isokinetic muscle strength
timeFrame: approx. 30 minutes at baseline (2 years after surgery)
measure: Proprioception (joint position sense)
timeFrame: approx. 30 minutes at baseline (2 years after surgery)
measure: Gait analysis
timeFrame: approx. 60 minutes at baseline (2 years after surgery)
measure: Postural stability
timeFrame: at baseline (2 years after surgery)
measure: Functional activity score to determine the ability "return to activity"
timeFrame: at baseline (2 years after surgery)
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: at baseline (2 years after surgery)
measure: International Knee Documentation Committee (IKDC)
timeFrame: at baseline (2 years after surgery)
measure: Tegner Activity Score
timeFrame: at baseline (2 years after surgery)
measure: EuroQoL-5D-5L (EQ 5D 5L)
timeFrame: at baseline (2 years after surgery)
measure: ACL- RSI Score
timeFrame: at baseline (2 years after surgery)
measure: Time to return to work
timeFrame: at baseline (2 years after surgery)
measure: Time to return to sports
timeFrame: at baseline (2 years after surgery)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Sebastian Mueller, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller S, Buhl L, Nuesch C, Pagenstert G, Mundermann A, Egloff C. RetroBRACE: clinical, socioeconomic and functional-biomechanical outcomes 2 years after ACL repair and InternalBrace augmentation in comparison to ACL reconstruction and healthy controls-experimental protocol of a non-randomised single-centre comparative study. BMJ Open. 2022 Feb 1;12(2):e054709. doi: 10.1136/bmjopen-2021-054709.