Cruciate Ligament RuptureNCT02993679
Stability of the Knee Joint After Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction
A study testing reconstruction of the ACL and anterolateral ligament in people with Cruciate Ligament Rupture, run by Hospital Znojmo.
Trial summary
The objective of this randomised cohort study was to evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when the ALL is necessary to reconstruct. Read more about this study
- Who is it for?
- Ages 17 to 40 years
- Conditions the study is for
- Cruciate Ligament Rupture
- What is being tested?
- reconstruction of the ACL and anterolateral ligament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Nov 2016
- 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 17 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The isolated ACL lesion
- The absence of the previous surgery on the knee joint
- The body mass index (BMI) less than 30.
Who cannot join
- Associated injuries of the tissue around the knee joint
About this study
Official title: Biomechanical Assessment of the Reconstruction of the Anterolateral Ligament During ACL Surgery. The In-vivo Study
The objective of this randomised cohort study was to evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when the ALL is necessary to reconstruct.
Read the detailed description
Background Rotational instability after the anterior cruciate ligament (ACL) injury and subsequent reconstruction may be caused by the rupture of the anterolateral structures of the knee, specifically the anterolateral ligament (ALL).
There are more techniques to improve the rotational stability of the knee. The objective of this randomised cohort study was: (1) To evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB). (2) To analyse when the ALL is necessary to reconstruct.
Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With another thirty patients the ACL was reconstructed performing DB technique with the use of hamstring tendons (DB group). The rotational stability was studied before and after the reconstruction of the ACL in time "zero" using the computer navigation system. In the ALL group, the rotational stability was also analysed after the ALL reconstruction.
- Conditions
- Cruciate Ligament Rupture
- Being tested
- reconstruction of the ACL and anterolateral ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reconstruction of the ACL and anterolateral ligamentProcedure or surgery
reconstruction of the ACL and anterolateral ligament
| Study group | Role | What they receive |
|---|---|---|
| double-bundle ACL reconstruction | Other | surgical reconstruction of the anterior cruciate ligament Receives: Procedure: reconstruction of the ACL and anterolateral ligament |
| anterolateral ligament reconstruction | Other | surgical reconstruction of the anterolateral ligament Receives: Procedure: reconstruction of the ACL and anterolateral ligament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.
Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.
Measured: 24 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cruciate Ligament RuptureStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Znojmo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Komzak Martin, M.D., Hospital Znojmo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993679
- Sponsor's protocol ID
- Hospital Znojmo
- Status last verified
- Dec 2016
- First submitted
- 4 Dec 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Assessment of the Reconstruction of the Anterolateral Ligament During ACL Surgery. The In-vivo Study
- ClinicalTrials.gov ID
- NCT02993679
- Acronym / sponsor ID
- Hospital Znojmo
- Conditions
- Cruciate Ligament Rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital ZnojmoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Dec 2016 (estimated)
- 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 objective of this randomised cohort study was to evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when the ALL is necessary to reconstruct.
Detailed description
Background Rotational instability after the anterior cruciate ligament (ACL) injury and subsequent reconstruction may be caused by the rupture of the anterolateral structures of the knee, specifically the anterolateral ligament (ALL).
There are more techniques to improve the rotational stability of the knee. The objective of this randomised cohort study was: (1) To evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB). (2) To analyse when the ALL is necessary to reconstruct.
Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With another thirty patients the ACL was reconstructed performing DB technique with the use of hamstring tendons (DB group). The rotational stability was studied before and after the reconstruction of the ACL in time "zero" using the computer navigation system. In the ALL group, the rotational stability was also analysed after the ALL reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double-bundle ACL reconstruction | Other | Procedure: reconstruction of the ACL and anterolateral ligamentsurgical reconstruction of the anterior cruciate ligament |
| anterolateral ligament reconstruction | Other | Procedure: reconstruction of the ACL and anterolateral ligamentsurgical reconstruction of the anterolateral ligament |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- The isolated ACL lesion
- The absence of the previous surgery on the knee joint
- The body mass index (BMI) less than 30.
Key exclusion criteria (1 listed)
- Associated injuries of the tissue around the knee joint
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 |
|---|---|---|
| reconstruction of the ACL and anterolateral ligamentreconstruction of the ACL and anterolateral ligament | Procedure or surgery | anterolateral ligament reconstruction, double-bundle ACL reconstruction |
Primary outcome
Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.
Time frame: 24 months after the operation
Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.
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 15 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing reconstruction of the ACL and anterolateral ligament in people with Cruciate Ligament Rupture, run by Hospital Znojmo.
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 3 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: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction. (time frame: 24 months after the operation). 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 15 Dec 2016.