Rupture of Anterior Cruciate LigamentNCT02074917
Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical ACL Reconstruction at AM or Central Position
A study testing Anatomical ACL reconstruction in people with Rupture of Anterior Cruciate Ligament and Complete Tear, Knee, Anterior Cruciate Ligament, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This is a prospective, randomized and double-blind clinical trial about anatomical single-bundle anterior cruciate ligament (ACL) reconstruction. One of the most common causes of ACL reconstruction failure is poor graft positioning. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament, Complete Tear, Knee, Anterior Cruciate Ligament
- What is being tested?
- Anatomical ACL reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to Oct 2015
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physical activity classified by Tegner scale ≥ 5
- Absence of other associated ligament injuries in the operated knee
- No ACL rerupture or previous ACL reconstruction in the same or other knee
- Absence of untreated lesions of the opposite knee
- No obvious change in the alignment of the mechanical axis that required surgical correction
- Athletes of both gender with a minimum age of 18 years and maximum of 45 years
- Signature of the consent term (IRB)
- Not be pregnant.
Who cannot join
- Request to stop the study by patient at any time
- Fracture not associated with the surgical procedure
- Do not carry out the rehabilitation protocol as oriented by the Sports Medicine group.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Ortopedia e Traumatologia do HCFMUSP
São Paulo, São Paulo, 05403010
Danilo RO Oliveira, MD, +5511983697729, ortopedistadanilo@hotmail.com
Tiago L Fernandes, MSc, MD, +5511983830123, tiago.lazzaretti@usp.br
About this study
Official title: Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical Single-bundle ACL at Anteromedial or Central Tunnel Position - Prospective, Randomized and Double-blind Clinical Trial in Athletes
This is a prospective, randomized and double-blind clinical trial about anatomical single-bundle anterior cruciate ligament (ACL) reconstruction.
One of the most common causes of ACL reconstruction failure is poor graft positioning. There is evidence that graft placement aligned with native insertion sites results in superior clinical outcomes. Current anatomic ACL reconstruction concepts highlight the importance of the native anatomy to restore physiological knee kinematics more accurately.
Read more
This study aims to investigate clinical outcomes and dynamic knee stability with force platform and other functional tests after ACL reconstruction in two different groups of tunnel position: anteromedial ACL footprint (AM) or central ACL footprint.
It was hypothesized that there would be clinical or dynamic stability differences between AM or Central tunnel groups in ACL reconstruction.
Read the detailed description
Tunnel position will be recorded and confirmed with postoperative computer tomography.
- Being tested
- Anatomical ACL reconstruction
- Keywords
- anterior cruciate ligament, ACL, anterior cruciate ligament reconstruction, outcome assessment, outcome assessment, patient, treatment outcome, exercise test, anatomic, anatomical, single-bundle, force platform, postural balance, biomechanics, CT scan, X-ray computed tomography, tomography, diagnostic imaging, knee, knee injuries, joint instability
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical ACL reconstructionProcedure or surgery
Also called anatomic ACL reconstruction, anatomic anterior cruciate ligament reconstruction, anatomical anterior cruciate ligament reconstruction, anterior cruciate ligament reconstruction
Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.
| Study group | Role | What they receive |
|---|---|---|
| AM anatomical ACL reconstruction | Experimental | Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction Receives: Procedure: Anatomical ACL reconstruction |
| CENTRAL anatomical ACL reconstruction | Experimental | Femoral and tibial tunnels performed in the center of ACL footprint Receives: Procedure: Anatomical ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Stability with force platform
Evaluation of dynamic stability in stand position and leg movements with force platform
Measured: 12 months
Secondary outcomes (6)
Change from baseline and between groups in Lysholm knee scoring scale
This is a validated scoring scale to evaluate outcomes of knee ligament surgery, particularly symptoms of instability. The total score is the sum of each response to the 8 items, of a possible score of 100.
Measured: 6, 12, 24 months
Change from baseline and between groups in Tegner activity score
This is a validated score for level of activity related to knee stability. It provides a standardized method of grading work and sporting activities from 0 to 10.
Measured: 6, 12, 24 months
Single leg hop test for distance - side to side difference
This test includes a single leg hop for distance comparison between involved leg vs. contra-lateral normal leg. Results are expressed as a percentage of the non-involved leg.
Measured: 6, 12 months
Isokinetic knee strength test - side to side difference
Quadriceps and hamstring isokinetic strength are assessed at velocities of 60 and 240 degrees per second and values are compared between involved operated leg and non-involved leg and between groups. Peak torque and flexion/extension rate are analyzed.
Measured: 6, 12 months
Change from baseline and between groups in Dynamic Stability with force platform
Evaluation of dynamic stability in stand position and leg movements with force platform. Antero-posterior and latero-medial movements are measured in metric scale. Area and velocity of movement are also calculated.
Measured: 6 months
Change from baseline and between groups in International Knee Documentation Committee form (IKDC)
The form is used to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. It is a validated 18-item patient measurement tool. that can be used for post-operatory ACL reconstruction
Measured: 6, 12 e 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startOct 2012
- Primary completionOct 2014 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rupture of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaldo José Hernandez, University of Sao Paulo
- Investigators
- Arnaldo J Hernandez, PhD, MSc, MD, Principal investigator, University of Sao PauloDanilo RO Oliveira, MD, Study director, University of Sao PauloTiago L Fernandes, MSc, MD, Study director, University of Sao PauloEllen CR Felix, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074917
- Sponsor's protocol ID
- HCFMUSP972
- Status last verified
- Mar 2014
- First submitted
- 24 Oct 2013
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zantop T, Wellmann M, Fu FH, Petersen W. Tunnel positioning of anteromedial and posterolateral bundles in anatomic anterior cruciate ligament reconstruction: anatomic and radiographic findings. Am J Sports Med. 2008 Jan;36(1):65-72. doi: 10.1177/0363546507308361. Epub 2007 Oct 11.
PubMed 17932407Misonoo G, Kanamori A, Ida H, Miyakawa S, Ochiai N. Evaluation of tibial rotational stability of single-bundle vs. anatomical double-bundle anterior cruciate ligament reconstruction during a high-demand activity - a quasi-randomized trial. Knee. 2012 Mar;19(2):87-93. doi: 10.1016/j.knee.2011.01.003. Epub 2011 Feb 12.
PubMed 21316972Forsythe B, Kopf S, Wong AK, Martins CA, Anderst W, Tashman S, Fu FH. The location of femoral and tibial tunnels in anatomic double-bundle anterior cruciate ligament reconstruction analyzed by three-dimensional computed tomography models. J Bone Joint Surg Am. 2010 Jun;92(6):1418-26. doi: 10.2106/JBJS.I.00654.
PubMed 20516317Musahl V, Plakseychuk A, VanScyoc A, Sasaki T, Debski RE, McMahon PJ, Fu FH. Varying femoral tunnels between the anatomical footprint and isometric positions: effect on kinematics of the anterior cruciate ligament-reconstructed knee. Am J Sports Med. 2005 May;33(5):712-8. doi: 10.1177/0363546504271747. Epub 2005 Feb 16.
PubMed 15722268Mohammadi F, Salavati M, Akhbari B, Mazaheri M, Khorrami M, Negahban H. Static and dynamic postural control in competitive athletes after anterior cruciate ligament reconstruction and controls. Knee Surg Sports Traumatol Arthrosc. 2012 Aug;20(8):1603-10. doi: 10.1007/s00167-011-1806-4. Epub 2011 Nov 29.
PubMed 22124847
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical Single-bundle ACL at Anteromedial or Central Tunnel Position - Prospective, Randomized and Double-blind Clinical Trial in Athletes
- ClinicalTrials.gov ID
- NCT02074917
- Acronym / sponsor ID
- HCFMUSP972
- Keywords
- anterior cruciate ligament, ACL, anterior cruciate ligament reconstruction, outcome assessment, outcome assessment, patient, treatment outcome, exercise test, anatomic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 28 Feb 2014 (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.
This is a prospective, randomized and double-blind clinical trial about anatomical single-bundle anterior cruciate ligament (ACL) reconstruction.
One of the most common causes of ACL reconstruction failure is poor graft positioning. There is evidence that graft placement aligned with native insertion sites results in superior clinical outcomes. Current anatomic ACL reconstruction concepts highlight the importance of the native anatomy to restore physiological knee kinematics more accurately.
This study aims to investigate clinical outcomes and dynamic knee stability with force platform and other functional tests after ACL reconstruction in two different groups of tunnel position: anteromedial ACL footprint (AM) or central ACL footprint.
It was hypothesized that there would be clinical or dynamic stability differences between AM or Central tunnel groups in ACL reconstruction.
Detailed description
Tunnel position will be recorded and confirmed with postoperative computer tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AM anatomical ACL reconstruction | Experimental | Procedure: Anatomical ACL reconstructionFemoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction |
| CENTRAL anatomical ACL reconstruction | Experimental | Procedure: Anatomical ACL reconstructionFemoral and tibial tunnels performed in the center of ACL footprint |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Physical activity classified by Tegner scale ≥ 5
- Absence of other associated ligament injuries in the operated knee
- No ACL rerupture or previous ACL reconstruction in the same or other knee
- Absence of untreated lesions of the opposite knee
- No obvious change in the alignment of the mechanical axis that required surgical correction
Key exclusion criteria (3 listed)
- Request to stop the study by patient at any time
- Fracture not associated with the surgical procedure
- Do not carry out the rehabilitation protocol as oriented by the Sports Medicine group.
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 |
|---|---|---|
| Anatomical ACL reconstructionAlso: anatomic ACL reconstruction, anatomic anterior cruciate ligament reconstruction, anatomical anterior cruciate ligament reconstruction, anterior cruciate ligament reconstructionAnatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions. | Procedure or surgery | AM anatomical ACL reconstruction, CENTRAL anatomical ACL reconstruction |
Primary outcome
Dynamic Stability with force platform
Time frame: 12 months
Evaluation of dynamic stability in stand position and leg movements with force platform
6 secondary outcomes
Change from baseline and between groups in Lysholm knee scoring scale
Time frame: 6, 12, 24 months
Change from baseline and between groups in Tegner activity score
Time frame: 6, 12, 24 months
Single leg hop test for distance - side to side difference
Time frame: 6, 12 months
Isokinetic knee strength test - side to side difference
Time frame: 6, 12 months
Change from baseline and between groups in Dynamic Stability with force platform
Time frame: 6 months
Change from baseline and between groups in International Knee Documentation Committee form (IKDC)
Time frame: 6, 12 e 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Background: PubMed 17932407Zantop T, Wellmann M, Fu FH, Petersen W. Tunnel positioning of anteromedial and posterolateral bundles in anatomic anterior cruciate ligament reconstruction: anatomic and radiographic findings. Am J Sports Med. 2008 Jan;36(1):65-72. doi: 10.1177/0363546507308361. Epub 2007 Oct 11.
- Background: PubMed 21316972Misonoo G, Kanamori A, Ida H, Miyakawa S, Ochiai N. Evaluation of tibial rotational stability of single-bundle vs. anatomical double-bundle anterior cruciate ligament reconstruction during a high-demand activity - a quasi-randomized trial. Knee. 2012 Mar;19(2):87-93. doi: 10.1016/j.knee.2011.01.003. Epub 2011 Feb 12.
- Background: PubMed 20516317Forsythe B, Kopf S, Wong AK, Martins CA, Anderst W, Tashman S, Fu FH. The location of femoral and tibial tunnels in anatomic double-bundle anterior cruciate ligament reconstruction analyzed by three-dimensional computed tomography models. J Bone Joint Surg Am. 2010 Jun;92(6):1418-26. doi: 10.2106/JBJS.I.00654.
- Background: PubMed 15722268Musahl V, Plakseychuk A, VanScyoc A, Sasaki T, Debski RE, McMahon PJ, Fu FH. Varying femoral tunnels between the anatomical footprint and isometric positions: effect on kinematics of the anterior cruciate ligament-reconstructed knee. Am J Sports Med. 2005 May;33(5):712-8. doi: 10.1177/0363546504271747. Epub 2005 Feb 16.
- Background: PubMed 22124847Mohammadi F, Salavati M, Akhbari B, Mazaheri M, Khorrami M, Negahban H. Static and dynamic postural control in competitive athletes after anterior cruciate ligament reconstruction and controls. Knee Surg Sports Traumatol Arthrosc. 2012 Aug;20(8):1603-10. doi: 10.1007/s00167-011-1806-4. Epub 2011 Nov 29.
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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.
Arnaldo J Hernandez, PhD, MSc, MD principal investigator
University of Sao Paulo
Danilo RO Oliveira, MD study director
University of Sao Paulo
Tiago L Fernandes, MSc, MD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomical ACL reconstruction in people with Rupture of Anterior Cruciate Ligament and Complete Tear, Knee, Anterior Cruciate Ligament, run by University of Sao Paulo 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 8 inclusion and 3 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 18 Mar 2014. 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 Arnaldo J Hernandez, PhD, MSc, MD (+551126616041, ajhernandez@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Stability with force platform (time frame: 12 months). 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 NCT02074917, which also lists 5 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 18 Mar 2014.