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

NCT ID: NCT03997071

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-17

Study Completion Date

2022-05-07

Brief Summary

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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

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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.

Conditions

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Rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annegret Muendermann, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Traumatology Universitätsspital Basel

Locations

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Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2019-00491; ch19Jakob

Identifier Type: -

Identifier Source: org_study_id

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