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Injury of the Anterior Cruciate Ligament (ACL)RetroBRACE IINCT04429165

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

An observational study of Injury of the Anterior Cruciate Ligament (ACL), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
collection of Patient Reported Outcome (PRO) data, collection of anthropometric and clinical functional data and gait analysis
How many people
68 participants
Where
1 siteSwitzerland
Study dates
23 Apr 2020to 14 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Patients who underwent ACL reconstruction using an autologous hamstring tendon between 03/18 and 04/20 at University Hospital Basel. 30 age-matched control subjects without previous history of knee injury and/or surgery will be included for comparison.

Who may be able to join

  • Patients: 2 years since ACL reconstruction with autologous hamstring tendon
  • Control subjects: no previous injury to the meniscus or the ligament apparatus of the knee

Who cannot join

  • BMI > 35 kg / m2
  • neuromuscular diseases that affect lower limb movement
  • Inability to give informed consent
  • Patients: previous injury or surgical treatment of the opposite side within the past 2 years and the injured leg within the past 6 months; other pathologies that affect the mobility of the knee

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Orthopaedics and Traumatology, University Hospital Basel

    Basel, 4031

Other trials in Switzerland

About this study

Official title: RetroBRACE II: Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction - Considering Socioeconomic Aspects and Return to Work

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.

Read the detailed description

Injury of the anterior cruciate ligament (ACL) is one of the most common injuries of the knee. Since May 2016, patients with proximal ruptures of the ACL have been treated with direct repair and InternalBraceTM Ligament Augmentation at the University Hospital of Basel.

The remodelling of hamstring grafts used for ACL reconstruction is completed at the earliest 2 years after the surgery. 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.

Being tested
collection of Patient Reported Outcome (PRO) data, collection of anthropometric and clinical functional data, gait analysis
Keywords
ACL rupture, primary ACL repair, ACL reconstruction using autologous hamstring tendons, InternalBraceTM Ligament Augmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • collection of Patient Reported Outcome (PRO) dataOther

    collection of Patient Reported Outcome (PRO) data by questionnaires

  • collection of anthropometric and clinical functional dataOther

    collection of anthropometric and clinical functional data including range of motion (ROM), isokinetic muscle strength, joint position sense, single leg balance ability, and muscle activity

  • gait analysisOther

    gait analysis in a motion capture volume on a walkway including force plates and on a treadmill with pressure plates, while 3D kinematics and kinetics, pressure and electromyographic (EMG) data will be recorded

Study groups in NCT04429165
Study groupRoleWhat they receive
ACL reconstructionACL reconstruction using an autologous hamstring tendon
Receives: Other: collection of Patient Reported Outcome (PRO) data; Other: collection of anthropometric and clinical functional data; Other: gait analysis
control groupknee-healthy, age-matched subjects as a control group
Receives: Other: collection of Patient Reported Outcome (PRO) data; Other: collection of anthropometric and clinical functional data; Other: gait analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Range of Motion (ROM) of the knee

    Range of Motion (ROM) of the knee

    Measured: at baseline (2 years after surgery)

  2. Isokinetic muscle strength

    Isokinetic muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). The maximum isokinetic flexion and extension torques will be measured on the knee between full extension and 90° flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (15 repetitions). Maximum torques will be recorded for each direction of movement and normalized to body weight.

    Measured: approx. 30 minutes at baseline (2 years after surgery)

  3. Proprioception (joint position sense)

    Proprioception will be measured bilaterally with a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA) using an active joint position sense protocol. The participants will be positioned on the dynamometer with knee and hip angles of 90°. They will then actively stretch their knees up to target angles of 60° or 30° flexion. Subjects will be asked to remember this position and then stretch their knees from a starting position of 90° flexion and, as soon as they think they have reached the target angle, push a stop button. The deviation between the perceived angle and the actual target angle will be calculated.

    Measured: approx. 30 minutes at baseline (2 years after surgery)

  4. Gait analysis

    Gait analysis performed on a treadmill with an integrated pressure plate and a walkway with two integrated force plates. Kinematic and EMG data collected using a 9-camera Vicon system and a 12-channel EMG system. To measure 3D joint angles, reflective markers will be attached to defined anatomical locations on the pelvis and legs.10 Bipolar surface electrodes will be attached bilaterally to the glutaeus medius, vastus medialis and lateralis, semitendinosus, tibialis anterior and gastrocnemius medialis muscles according to the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles). Study participants walk at self-selected speed. In addition, patients walk on treadmill at a self-selected speed, at a speed of 1.2 m/s and to run at self-selected speed and if possible at 2.2m/s. Kinematic and kinetic, EMG and pressure data recorded for all testing conditions.

    Measured: approx. 60 minutes at baseline (2 years after surgery)

  5. Postural stability

    The stability of posture and balancing will be determined by the variability of movement in the horizontal plane and the length of the pressure line during two 30-second single- leg stands (on solid surface and on foam surface) on a force plate (Kistler 9260AA6, Kistler AG, Winterthur, Switzerland; sampling frequency, 2400 Hz) and mathematical calculations

    Measured: at baseline (2 years after surgery)

  6. Functional activity score to determine the ability "return to activity"

    Functional activity tests include the Y-balance test, single-leg jump for distance, side jumps for time (30 seconds) and precision over a distance of 40 cm (side hop). The quantity of movement of these functional scores will be calculated.

    Measured: at baseline (2 years after surgery)

Secondary outcomes (7)

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee Problems.

    Measured: at baseline (2 years after surgery)

  2. International Knee Documentation Committee (IKDC)

    The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function

    Measured: at baseline (2 years after surgery)

  3. Tegner Activity Score

    Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports.

    Measured: at baseline (2 years after surgery)

  4. EuroQoL-5D-5L (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).

    Measured: at baseline (2 years after surgery)

  5. ACL- RSI Score

    The ALC-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each. It is considered that for a normal population without knee condition, the score is between 80 and 90%

    Measured: at baseline (2 years after surgery)

  6. Time to return to work

    Socioeconomic aspect: time to return to work

    Measured: at baseline (2 years after surgery)

  7. Time to return to sports

    Time to return to sports

    Measured: at baseline (2 years after surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2020
  2. Study start23 Apr 2020
  3. Primary completion14 Jul 2022
  4. Study completion14 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04429165
Sponsor's protocol ID
2020-00551; ch20Rikli
Acronym
RetroBRACE II
Status last verified
Jan 2023
First submitted
9 Jun 2020
Last updated
19 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Buhl L, Muller S, Nuesch C, Boyer KA, Casto E, Mundermann A, Egloff C. Ambulatory knee biomechanics and muscle activity 2 years after ACL surgery: InternalBraceTM-augmented ACL repair versus ACL reconstruction versus healthy controls. BMC Musculoskelet Disord. 2023 Oct 4;24(1):785. doi: 10.1186/s12891-023-06916-7.

    PubMed 37794432

  • Buhl L, Muller S, Nuesch C, Pagenstert G, Mundermann A, Egloff C. Functional leg performance 2 years after ACL surgery: a comparison between InternalBrace-augmented repair versus reconstruction versus healthy controls. J Orthop Traumatol. 2023 Sep 21;24(1):52. doi: 10.1186/s10195-023-00723-5.

    PubMed 37735271

  • Muller S, Buhl L, Nuesch C, Pagenstert G, Mundermann A, Egloff C. Favorable Patient-Reported, Clinical, and Functional Outcomes 2 Years After ACL Repair and InternalBrace Augmentation Compared With ACL Reconstruction and Healthy Controls. Am J Sports Med. 2023 Oct;51(12):3131-3141. doi: 10.1177/03635465231194784. Epub 2023 Sep 7.

    PubMed 37675973

  • Muller S, Buhl L, Nuesch C, Pagenstert G, Mundermann A, Egloff C. 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. BMJ Open. 2022 Feb 1;12(2):e054709. doi: 10.1136/bmjopen-2021-054709.

    PubMed 35105587

Questions about this trial

What is this clinical trial studying?

An observational study of Injury of the Anterior Cruciate Ligament (ACL), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Range of Motion (ROM) of the knee (time frame: at baseline (2 years after surgery)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04429165, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.

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