Clinical trial NCT03997071: RetroBRACE - Clinical and Functional Outcomes 2 Years After Primary ACL Repair (Internal Bracing)
Official title: RetroBRACE - Clinical and Functional Outcomes 2 Years After Primary ACL Repair (Internal Bracing)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rupture
Keywords: ACL repair
Internal Brace Ligament Augmentation
ACL reconstruction
Anterior Cruciate Ligament Rupture
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated between 05/2016 and 06/2018 with ACL repair and Internal Brace Ligament Augmentation at the Clinic of Orthopaedics and Traumatology of the University Hospital Basel

Brief summary: The purpose of this study is to quantify 2-year postoperative clinical and functional outcomes including side-to-side differences in gait function, balance, proprioception and muscle strength in patients treated by ACL repair with Internal Brace Ligament Augmentation.

Detailed description: Rupture of the anterior cruciate ligament (ACL) is one of the most common injuries. In recent years, arthroscopic techniques have rapidly evolved with advanced tools such as suture anchors, resolvable pins and internal bracing techniques. One of the very latest developments in internal bracing and repair for proximal ACL ruptures is the InternalBraceTM (Arthrex Inc., Naples, Florida, USA). The purpose of this study is to quantify 2-year postoperative clinical and functional outcomes including side-to-side differences in gait function, balance, proprioception and muscle strength in patients treated by ACL repair with Internal Brace Ligament Augmentation.

Eligibility criteria: Inclusion Criteria:

* 2 years since ACL repair and Internal Brace Ligament Augmentation

Exclusion Criteria:

* Revision surgery within 2 years after primary repair (ACL, Total or Partial Knee Arthroplasty, Joint Infection, Fracture around knee level)
* BMI \> 35 kg/m2
* Previous injury and surgical procedures of the contralateral knee
* Neuromuscular disorders affecting lower limb movement
* Additional pathologies that influence the mobility of the knee joints
* Inability to provide informed consent

Primary outcomes:
measure: joint position sense Analysis (proprioception)
timeFrame: single time point assessment (2 years after surgery)
measure: muscle strength
timeFrame: single time point assessment (2 years after surgery)
measure: gait analysis
timeFrame: single time point assessment (2 years after surgery)
measure: maximum jump height (cm)
timeFrame: single time point assessment (2 years after surgery)
measure: Euroquol 5 Dimensions (EQ-5D-5L)
timeFrame: single time point assessment (2 years after surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology Universitätsspital Basel
name: Annegret Muendermann, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: