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

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ClinicalTrials.gov Identifier: NCT03997071
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment
Rupture 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RetroBRACE - Clinical and Functional Outcomes 2 Years After Primary ACL Repair (Internal Bracing)
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : May 7, 2021
Estimated Study Completion Date : May 7, 2021

Intervention Details:
  • Other: functional outcome measurement
    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


Primary Outcome Measures :
  1. joint position sense Analysis (proprioception) [ Time Frame: single time point assessment (2 years after surgery) ]
    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.

  2. muscle strength [ Time Frame: single time point assessment (2 years after surgery) ]
    Muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA).

  3. gait analysis [ Time Frame: single time point assessment (2 years after surgery) ]
    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).

  4. maximum jump height (cm) [ Time Frame: single time point assessment (2 years after surgery) ]
    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

  5. Euroquol 5 Dimensions (EQ-5D-5L) [ Time Frame: single time point assessment (2 years after surgery) ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997071


Contacts
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Contact: Annegret Muendermann, Prof. Dr. MD +41 61 328 5445 annegret.muendermann@usb.ch
Contact: Sebastian Mueller, Dr. med sebastian.mueller@usb.ch

Locations
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Switzerland
Department of Orthopaedics and Traumatology, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Annegret Muendermann, Prof.Dr. MD    +41 61 328 5445    annegret@muendermann@usb.ch   
Sub-Investigator: Sebastian Mueller, Dr. med         
Sub-Investigator: Christian Egloff, Dr. med         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Annegret Muendermann, Prof. Dr. MD Department of Orthopaedics and Traumatology Universitätsspital Basel
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03997071    
Other Study ID Numbers: 2019-00491; ch19Jakob
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
ACL repair
Internal Brace Ligament Augmentation
ACL reconstruction
Anterior Cruciate Ligament Rupture
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries