RuptureRetroBRACENCT03997071
RetroBRACE - Clinical and Functional Outcomes 2 Years After Primary ACL Repair (Internal Bracing)
An observational study of Rupture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rupture
- What is being tested?
- functional outcome measurement
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Apr 2019to 7 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 2 years since ACL repair and Internal Brace Ligament Augmentation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
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.
Read the 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.
- Conditions
- Rupture
- Being tested
- functional outcome measurement
- Keywords
- ACL repair, Internal Brace Ligament Augmentation, ACL reconstruction, Anterior Cruciate Ligament Rupture
- Medical subject headings
- Rupture, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional outcome measurementOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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).
Measured: single time point assessment (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.
- First posted25 Jun 2019
- Study start17 Apr 2019
- Primary completion7 May 2022
- Study completion7 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RuptureStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Muendermann, Prof. Dr. MD, Principal investigator, Department of Orthopaedics and Traumatology Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997071
- Sponsor's protocol ID
- 2019-00491; ch19Jakob
- Other IDs
- 2019
- Acronym
- RetroBRACE
- Status last verified
- May 2023
- First submitted
- 12 Jun 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RetroBRACE - Clinical and Functional Outcomes 2 Years After Primary ACL Repair (Internal Bracing)
- ClinicalTrials.gov ID
- NCT03997071
- Acronym / sponsor ID
- RetroBRACE / 2019-00491; ch19Jakob
- Conditions
- Rupture
- Keywords
- ACL repair, Internal Brace Ligament Augmentation, ACL reconstruction, Anterior Cruciate Ligament Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 7 May 2022 (actual)
- Study completion
- 7 May 2022 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 2 years since ACL repair and Internal Brace Ligament Augmentation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional outcome measurementfunctional 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 | Other | – |
Primary outcome
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.
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).
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).
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annegret Muendermann, Prof. Dr. MD principal investigator
Department of Orthopaedics and Traumatology Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rupture, 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 1 inclusion and 6 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 9 May 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?
joint position sense Analysis (proprioception) (time frame: single time point assessment (2 years after surgery)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.