Knee InjuriesNCT04550299
ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
A study testing Surgical technique combined with a specific choice of the material for the ligament reconstruction in people with Knee Injuries and ACL Tear, run by Vita Care at 1 site in Brazil.
Trial summary
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Knee Injuries, ACL Tear, ACL Injury
- What is being tested?
- Surgical technique combined with a specific choice of the material for the ligament reconstruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Feb 2013to 1 Dec 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- isolated ACL injury for more than six weeks by physical examination and confirmed by magnetic resonance, adult non-elderly (18 to 60 years), nonobese (body mass index within the normal range)
Who cannot join
- intraoperative complications requiring change in technique of reconstruction and / or anesthesia during surgery, patients undergoing cartilage piercing procedures ( such as microfractures) and / or meniscus suture, those with allergies to medications administered during anesthesia, surgery and / or post-operative patients with tourniquet time of more than two hours and patients who did not sign the consent form
Trial locations and contacts
1 site in 1 country.
Instituto Vita contact
Wagner Castropil contact
Brazil1 site, 1 recruiting
- Recruiting
Instituto Vita
São Paulo, São Paulo, 01239-040
Wagner Castropil, PhD, castropil@institutovita.com.br
About this study
Official title: Results of the Anterior Cruciate Ligament Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.
Read the detailed description
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.
This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant.
Primary outcome is graft ligamentization assessed in MRI images at 4-6 months
- Conditions
- Knee Injuries, ACL Tear, ACL Injury, Sports Injury
- Being tested
- Surgical technique combined with a specific choice of the material for the ligament reconstruction
- Medical subject headings
- Knee Injuries, Anterior Cruciate Ligament Injuries, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical technique combined with a specific choice of the material for the ligament reconstructionOther
The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | single bundle technique with the use of bioabsorbable implants Receives: Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction |
| Group B | Active comparator | single bundle technique with the use of Bio-Intrafix Receives: Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction |
| Group C | Active comparator | double bundle technique with the use of bioabsorbable implants Receives: Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction |
| Group D | Active comparator | double bundle technique with the use of Bio-Intrafix Receives: Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone-graft integration
Bone-graft integration assessed in the MRI
Measured: 4-6 months
Secondary outcomes (2)
Clinical scores
Knee laxity (KT1000, 0 to 5 mm range, higher scores = worse outcome), Objective and Subjective International Knee Documentation Committee (Objective IKDC: 0-100 range, higher scores = better outcomes; Subjective IKDC: A-D range; A = better outcomes) scores, Lysholm score (0-100 range, higher scores = better outcomes) and Tegner Activity Scale (0-10 range, higher scores = higher levels of physical activity/ competitive sport activity)
Measured: 4-12 months
Retear
Retear of the reconstructed ACL
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start26 Feb 2013
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vita Care
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Wagner Castropil, Principal investigator, Instituto Vita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550299
- Sponsor's protocol ID
- 022
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of the Anterior Cruciate Ligament Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
- ClinicalTrials.gov ID
- NCT04550299
- Acronym / sponsor ID
- 022
- Conditions
- Knee Injuries, ACL Tear, ACL Injury, Sports Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Vita CareUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 26 Feb 2013 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 16 Sep 2020 (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.
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.
Detailed description
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.
This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant.
Primary outcome is graft ligamentization assessed in MRI images at 4-6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Surgical technique combined with a specific choice of the material for the ligament reconstructionsingle bundle technique with the use of bioabsorbable implants |
| Group B | Active comparator | Other: Surgical technique combined with a specific choice of the material for the ligament reconstructionsingle bundle technique with the use of Bio-Intrafix |
| Group C | Active comparator | Other: Surgical technique combined with a specific choice of the material for the ligament reconstructiondouble bundle technique with the use of bioabsorbable implants |
| Group D | Active comparator | Other: Surgical technique combined with a specific choice of the material for the ligament reconstructiondouble bundle technique with the use of Bio-Intrafix |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- isolated ACL injury for more than six weeks by physical examination and confirmed by magnetic resonance, adult non-elderly (18 to 60 years), nonobese (body mass index within the normal range)
Key exclusion criteria (1 listed)
- intraoperative complications requiring change in technique of reconstruction and / or anesthesia during surgery, patients undergoing cartilage piercing procedures ( such as microfractures) and / or meniscus suture, those with allergies to medications administered during anesthesia, surgery and / or post-operative patients with tourniquet time of more than two hours and patients who did not sign the consent form
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 |
|---|---|---|
| Surgical technique combined with a specific choice of the material for the ligament reconstructionThe surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice | Other | Group A, Group B, Group C, Group D |
Primary outcome
Bone-graft integration
Time frame: 4-6 months
Bone-graft integration assessed in the MRI
2 secondary outcomes
Clinical scores
Time frame: 4-12 months
Retear
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Instituto Vita contact
Wagner Castropil contact
Wagner Castropil principal investigator
Instituto Vita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical technique combined with a specific choice of the material for the ligament reconstruction in people with Knee Injuries and ACL Tear, run by Vita Care at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Sep 2020. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Instituto Vita (institutovita@institutovita.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone-graft integration (time frame: 4-6 months). 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 16 Sep 2020.