NCT04429165: RetroBRACE II

Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction

Completed Last updated 19 January 2023

What this trial tests

trial testing collection of Patient Reported Outcome (PRO) data in Injury of the Anterior Cruciate Ligament (ACL) in 68 participants. Completed in 14 July 2022.

Timeline

23 April 2020

Primary endpoint
14 July 2022

14 July 2022

Quick facts

Lead sponsor	University Hospital, Basel, Switzerland
Status	Completed
Study type	OBSERVATIONAL
Enrollment	68
Start date	23 April 2020
Primary completion	14 July 2022
Estimated completion	14 July 2022
Sites	1 location across Switzerland

Drugs / interventions tested

• collection of Patient Reported Outcome (PRO) data
• collection of anthropometric and clinical functional data
• gait analysis

Conditions studied

• Injury of the Anterior Cruciate Ligament (ACL) — all drugs for Injury of the Anterior Cruciate Ligament (ACL) →

Sponsor

University Hospital, Basel, Switzerland

Who can join

Adults 18 to 60, any sex, with Injury of the Anterior Cruciate Ligament (ACL). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct comparison to ACL reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. In addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Favorable Patient-Reported, Clinical, and Functional Outcomes 2 Years After ACL Repair and InternalBrace Augmentation Compared With ACL Reconstruction and Healthy Controls.
   Müller S, Bühl L, Nüesch C, Pagenstert G, et al · · 2023 · cited 22× · PMID 37675973 · DOI 10.1177/03635465231194784
2. Ambulatory knee biomechanics and muscle activity 2 years after ACL surgery: InternalBrace^TM-augmented ACL repair versus ACL reconstruction versus healthy controls.
   Bühl L, Müller S, Nüesch C, Boyer KA, et al · · 2023 · cited 13× · PMID 37794432 · DOI 10.1186/s12891-023-06916-7
3. Functional leg performance 2 years after ACL surgery: a comparison between InternalBrace™-augmented repair versus reconstruction versus healthy controls.
   Bühl L, Müller S, Nüesch C, Pagenstert G, et al · · 2023 · cited 8× · PMID 37735271 · DOI 10.1186/s10195-023-00723-5
4. RetroBRACE: clinical, socioeconomic and functional-biomechanical outcomes 2 years after ACL repair and InternalBrace augmentation in comparison to ACL reconstruction and healthy controls-experimental protocol of a non-randomised single-centre comparative study.
   Müller S, Bühl L, Nüesch C, Pagenstert G, et al · · 2022 · cited 8× · PMID 35105587 · DOI 10.1136/bmjopen-2021-054709
5. Landing Biomechanics in Patients 2 Years After Augmented ACL Repair and 2 Years After Hamstring Autograft ACL Reconstruction Compared With Controls.
   Bühl L, Müller S, Nüesch C, Halbeisen FS, et al · · 2025 · PMID 40734764 · DOI 10.1177/23259671251358386