Rupture of Anterior Cruciate LigamentNCT01391650
Stability of the Knee Joint After Single and Double Bundle Anterior Cruciate Ligament Reconstruction
A study testing 'biomechanic of the knee' in people with Rupture of Anterior Cruciate Ligament, run by Hospital Znojmo at 1 site in Czechia.
Trial summary
The purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament and to compare the stability after single-bundle and double-bundle… Read more about this study
- Who is it for?
- Ages 18 to 53 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- What is being tested?
- 'biomechanic of the knee'
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- Mar 2010to May 2011
- 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 53 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- isolated ACL lesion and primary ACL replacement
Who cannot join
- replacement of ACL with navigation system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rotational and Anteroposterior Stability of the Knee Joint After Single- and Double- Bundle ACL Reconstruction
The purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament and to compare the stability after single-bundle and double-bundle reconstruction using a computer navigation system.
Read the detailed description
The purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament (ACL) and to compare the stability after single-bundle and double-bundle reconstruction using a computer navigation system.
Methods Anterior-posterior translation, internal rotation, and external rotation were recorded in the deficient condition (without ACL), in the anteromedial-reconstructed, posterolateral-reconstructed, and in the whole ACL-reconstructed condition for double-bundle reconstructions and before and after the ACL reconstruction in single-bundle group. KT-1000 was used to evaluate anterior-posterior translation.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Being tested
- 'biomechanic of the knee'
- Keywords
- ACL, double-bundle, navigation system
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'biomechanic of the knee'Procedure or surgery
Also called replacement of ACL
20 patients had their ACL replaced by SB reconstruction from hamstrings, 20 patients double - bundle technique with AM bundle being reconstructed first, and 20 patients with the PL bundle first.
| Study group | Role | What they receive |
|---|---|---|
| biomechanic of the knee | Experimental | Not described Receives: Procedure: 'biomechanic of the knee' |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of rotational and anterior-posterior movement tibia to femur before the replacement of ACL
measurement of rotational and anterior-posterior movement tibia to femur before the replacement the ACL (single bundle)or after the tonisation of one portion of ACL in double bundle type of reconstruction of ACL in the operating sale
Measured: one hour
Secondary outcomes (1)
measurement of rotational and anterior-posterior movement tibia to femur after the replacement of ACL
measurement of rotational and anterior-posterior movement tibia to femur after the replacement the ACL (single bundle)or after the tonisation of second portion of ACL in double bundle type of reconstruction of ACL in the operating sale
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startMar 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Anterior Cruciate LigamentStudies 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
- Basic science
- 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
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Komzak Martin, M.D., Hospital Znojmo
- Investigators
- Martin Komzák, Principal investigator, Hospital Znojmo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391650
- Sponsor's protocol ID
- DBVSB
- Status last verified
- May 2012
- First submitted
- 20 May 2011
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational and Anteroposterior Stability of the Knee Joint After Single- and Double- Bundle ACL Reconstruction
- ClinicalTrials.gov ID
- NCT01391650
- Acronym / sponsor ID
- DBVSB
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- ACL, double-bundle, navigation system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital ZnojmoUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- Mar 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Jul 2011 (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 purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament and to compare the stability after single-bundle and double-bundle reconstruction using a computer navigation system.
Detailed description
The purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament (ACL) and to compare the stability after single-bundle and double-bundle reconstruction using a computer navigation system.
Methods Anterior-posterior translation, internal rotation, and external rotation were recorded in the deficient condition (without ACL), in the anteromedial-reconstructed, posterolateral-reconstructed, and in the whole ACL-reconstructed condition for double-bundle reconstructions and before and after the ACL reconstruction in single-bundle group. KT-1000 was used to evaluate anterior-posterior translation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biomechanic of the knee | Experimental | Procedure: 'biomechanic of the knee' |
Who may qualify
- Ages
- 18 to 53 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- isolated ACL lesion and primary ACL replacement
Key exclusion criteria (1 listed)
- replacement of ACL with navigation system
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 |
|---|---|---|
| 'biomechanic of the knee'Also: replacement of ACL20 patients had their ACL replaced by SB reconstruction from hamstrings, 20 patients double - bundle technique with AM bundle being reconstructed first, and 20 patients with the PL bundle first. | Procedure or surgery | biomechanic of the knee |
Primary outcome
measurement of rotational and anterior-posterior movement tibia to femur before the replacement of ACL
Time frame: one hour
measurement of rotational and anterior-posterior movement tibia to femur before the replacement the ACL (single bundle)or after the tonisation of one portion of ACL in double bundle type of reconstruction of ACL in the operating sale
1 secondary outcome
measurement of rotational and anterior-posterior movement tibia to femur after the replacement of ACL
Time frame: one hour
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 23 May 2012.
- web page of investigator affiliationLink provided by the sponsor.
Related trials for Rupture of Anterior Cruciate Ligament
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
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Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Recruiting
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
ACL - Anterior Cruciate Ligament Rupture
Not yet recruiting
SharkScrew ACL RCT
ACL - Anterior Cruciate Ligament Rupture
Active, not recruiting
Over-the-Top vs. Anteromedial ACLR With Lateral Extraarticular Tenodesis
Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries
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.
Martin Komzák principal investigator
Hospital Znojmo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'biomechanic of the knee' in people with Rupture of Anterior Cruciate Ligament, run by Hospital Znojmo at 1 site in Czechia.
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: finished, as of the sponsor's last update on 23 May 2012. 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 Czechia. 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?
measurement of rotational and anterior-posterior movement tibia to femur before the replacement of ACL (time frame: one hour). 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 23 May 2012; AzTrials last refreshed its copy on 3 Nov 2026.