RetroBRACE - Clinical and Functional Outcomes 2 Years After Primary ACL Repair (Internal Bracing) (RetroBRACE)

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.

Study Overview

• Status: Completed
• Conditions: Rupture
• Intervention / Treatment: Other: functional outcome measurement

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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Orthopaedics and Traumatology, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
joint position sense Analysis (proprioception)	Proprioception will be assessed bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA) with an active joint position sense protocol. Participants will be positioned with hips and knees flexed at 90°. The subjects will then actively extend their knee to the target angles of 60° or 20° flexion, respectively. The subjects will be asked to remember this position. Starting from 90° flexion they will then be asked to extend their knee and reproduce the remembered target flexion angle pressing a stop button when they think they reached the angle. The difference between the perceived angle and the initial target angle will be calculated.	single time point assessment (2 years after surgery)
muscle strength	Muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA).	single time point assessment (2 years after surgery)
gait analysis	Instrumented gait analysis on treadmill with embedded plantar pressure plate (h/p/cosmos, Zebris FDM-T, Isny, Germany; 7168 sensors; area, 1.5 * 0.5 m; range, 1-120 N/cm2; precision, 1-120 N/cm2 ± 5%; sampling rate, 120 Hz) and on an overground walkway with two embedded force plates (Kistler force plate 9260AA6, Kistler AG, Winterthur, Switzerland; sampling rate 2400 Hz). Patients walk barefoot for 2 minutes at 0% slope at their preferred walking speed and at 1 m/s followed by walking at preferred walking speed. The treadmill speed will be increased to preferred running speed, and data for 2 minutes running will be recorded. Maximum flexion and extension angles and joint moments will be computed using the Biomove software (Stanford University).	single time point assessment (2 years after surgery)
maximum jump height (cm)	Participants will perform three single leg hops on each leg. Maximum jump height will be determined as the highest position of the pelvis marker compared to a standing trial	single time point assessment (2 years after surgery)
Euroquol 5 Dimensions (EQ-5D-5L)	EQ-5D-5L questionnaire measuring generic health Status; descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 55555 (having extreme problems in all dimensions).	single time point assessment (2 years after surgery)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Annegret Muendermann, Prof. Dr. MD, Department of Orthopaedics and Traumatology Universitätsspital Basel

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): May 7, 2022
• Study Completion (Actual): May 7, 2022

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Anterior Cruciate Ligament Rupture; ACL reconstruction; ACL repair; Internal Brace Ligament Augmentation
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 2019-00491; ch19Jakob

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No