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

NCT03997071 | Completed

• 1 other identifier: 2019-00491; ch19Jakob
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Rupture

Keywords

ACL repair; Internal Brace Ligament Augmentation; ACL reconstruction; Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (5)

• 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)

Interventions

functional outcome measurement OTHER

functional outcome measured in terms of joint position sense analysis, isokinetic muscle strength measurements, gait analysis, drop jump and single leg hop tests, and balance tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• years since ACL repair and Internal Brace Ligament Augmentation

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Rupture; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries; Knee Injuries; Leg Injuries

Study Officials

• Annegret Muendermann, Prof. Dr. MD

  Department of Orthopaedics and Traumatology Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 25, 2019
• Study Start: April 17, 2019
• Primary Completion: May 7, 2022
• Study Completion: May 7, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

CH (1)