Unilateral Primary Osteoarthritis of HipPhase 2COMPALANCT01616667
Comparing the Clinical Effects of Posterior Approach Versus Lateral Approach in Osteoarthritis Patients With a THA
A Phase 2 study testing Total hip arthroplasty in people with Unilateral Primary Osteoarthritis of Hip, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the clinical outcome of the two different, but widely used, surgical approaches (Posterior approach and Lateral approach) of primary total hip arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main study and two sub-studies. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Primary Osteoarthritis of Hip
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to May 2015
- Phase
- Phase 2
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 45-70 years, both included.
- Patients schedule for primary cementless total hip arthroplasty.
- Endstage hip osteoarthritis(OA) or minor dysplasia of the hip(CE-angle > 20 degrees).
Who cannot join
- more major joint (hip or knee) than the current hip affected with OA, with expected joint replacement surgery within a year.
- Prior joint replacement surgery on any major joint (hip, knee) in lower limb.
- BMI above 35.
- Any physical disability that prevents patients from walking 20 meters without aid.
- The patients is not suitable for standard cementless prosthetic components.
- Any neurological disease (ex. cerebral thrombosis, Parkinson) compromising the walking ability.
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- Any severe medical condition compromising walking ability (ex. chronic heart failure, chronic obstructive pulmonary disease).
- Severe dementia.
- Inability to read and understand Danish writing and oral instructions.
- Do not want to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Posterior Approach Versus Lateral Approach in Osteoarthritis Patients, With Primary Total Hip Arthroplasty. The Effect on Early Physical Function, Pain, Patient Reported Outcome Measures, Gait and Muscle Weakness A Randomized Clinical Trial
The aim of this study is to investigate the clinical outcome of the two different, but widely used, surgical approaches (Posterior approach and Lateral approach) of primary total hip arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main study and two sub-studies. The main study investigates the patient-reported outcome measures (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the level of physical function and pain within the first 3 month after surgery, and ii) investigate the potential difference the two approaches have on gait-patterns and maximal isometric hip-muscle-strength, within the first year after surgery. Both approaches are described with potential drawbacks. Posterior approach has a higher risk of dislocation of the prostheses and revision due to dislocation compared with Lateral approach. Contrary, Lateral approach is described with the potential drawbacks of pain, lower physical function, gait abnormalities and muscle weakness, leading to less satisfied patients. However, according to a Cochrane analysis from 2004 concludes, more investigation is needed to determine the extent of differences.
- Conditions
- Unilateral Primary Osteoarthritis of Hip
- Being tested
- Total hip arthroplasty
- Keywords
- Controlled Clinical Trial, Operative Surgical Procedures, Treatment Outcome, Pain Measurement, Quality of Life, Questionnaires/standards, Activities of Daily Living, Biomechanics, Gait*, Hip Joint/physiology*, Hip Joint/surgery*, Recovery of Function/physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyProcedure or surgery
The patients included is operated with a total hip arthroplasty due to primary osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Modified direct lateral approach | Active comparator | The patients included is operated with a total hip arthroplasty using a modified direct lateral approach Receives: Procedure: Total hip arthroplasty |
| Posterior approach | Active comparator | The patients included is operated with a total hip arthroplasty using posterior approach Receives: Procedure: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 12 month
Primary study:
Hip Disability and Osteoarthritis Outcome Score (HOOS) includes five subscales: 1)Pain 2) Other symptoms 3) Activities of daily living(ADL) 4) Sport and recreation function and 5) Hip related quality of life. HOOS-Physical Function Short form (HOOS-PS) is an aggregation and shortening of the two original subscales of HOOS-ADL and Sport and Recreation. HOOS-PS is a validated instrument. HOOS has been translated to Danish.
We will use HOOS-PS as primary outcome.
Measured: Endpoint 12 month
Secondary outcomes (18)
Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month
Primary study
Measured: Baseline, 3 month, 6 month and endpoint 12 month
Hip Disability and Osteoarthritis Outcome Score (HOOS)-Hip related quality of life, 12 month
Primary study
Measured: Baseline, 3 month, 6 month and endpoint 12 month
University of California Los Angeles activity score (UCLA), 12 month
Primary study:
University of California Los Angeles activity score (UCLA) is a score focusing on patient activity level. The score is based on a scale from 1 to 10, ranging from inactive to regularly participate in impact sport or heavy labor. UCLA contributes with important qualitative information with regard to patient activity in correlation with other clinical outcome measures. UCLA is found reliable and valid and is translated to Danish.
Measured: Baseline, 3 month, 6 month and endpoint 12 month
EQ-5D self-rated health index -and EQ VAS scores, 12 month
Primary study:
EuroQol/EQ-5D is a standardized, reliable and validated instrument to measure quality of life. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and the EQ VAS that records the respondent's overall self-rated health on a vertical, visual analogue scale. EQ-5D is translated to Danish.
Measured: Baseline, 3 month, 6 month and endpoint 12 month
The 20 meter walk-test (20MeWa)
Sub-study 1:
The 20 meter walk-test (20MeWa). Patients are instructed to walk 20 meters between two clearly visible lines marked on the floor. The patients are instructed to walk with their usual pace on two trials and on the two following trials to walk at maximal pace, at which they feel secure. The mean velocity of each two trials are used for further analysis.
Measured: Baseline, 3 days, 21 days and endpoint 3 month
"Timed Up and Go"- test (TUG), 3 month
Sub-study 1:
The "Timed Up and Go" test (TUG) measures the time it takes a person to rise from a chair walk 3 meters, turn and walk back to the chair and sit down again. TUG is found to be a reliable and valid test for quantifying functional mobility.
Measured: Baseline, 3 days, 21 days and endpoint 3 month
"Repeated chair rise"- test (RCR), 3 month
Sub-study 1:
"Repeated chair rise"- test (RCR) assess the strength of the lower limb muscles overall. The test measures the maximum "stand and sit" cycles the test-person can perform on a chair within in 30 seconds. The test has been showed to gives a reliable and valid measurement of lower body strength in generally active older adults.
Measured: Baseline, 3 days, 21 days and endpoint 3 month
30 seconds maximal repeated unilateral knee bending, 3 month
Sub-study 1:
30 seconds maximal repeated unilateral knee bending. It evaluates the maximum number of knee bends performed on one leg in 30 seconds and the ability to execute fast coupled eccentric-concentric muscle force over the knee joint. The patient stand aligned with the front of their foot touching a straight line taped to the floor; finger tip support for balance is provided by the examiner. The patient is then asked to bend the knee, without bending forward from the hip, until he/she could no longer see the line at the toes (about 30º of knee flexion).
Measured: Baseline, 3 days, 21 days and endpoint 3 month
Opioid consumption, 3 month
Sub-study 1:
The opioid consumption will be patient administrated and recorded each day, the first 5 days after surgery. After discharged the patient will fill in a patients-diary, where the analgesics consumption are registered.
Measured: Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
Self-reported pain on a numerical ranking scale(NRS), 3 month
Sub-study 1:
The self-reported pain on a numerical ranking scale(NRS)will be recorded each day, the first 5 days after surgery. After discharged the patient will fill in a patients-diary, where the NRS are registered.
Measured: Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 3 month
Sub-study 1:
We will use the Hip Disability and Osteoarthritis Outcome Score (HOOS)subscales -Pain.
It will be recorded after discharged in a patients-diary
Measured: Baseline, 5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
Hip Range of motion (ROM), 3 month
Sub-study 1:
Range of motion in the hip joint evaluated by goniometer at baseline and 3 month post-surgery Extension/Flexion. Abduction/adduction. Internal/external rotation.
Measured: Baseline and endpoint 3 month
Gait Deviation Index(GDI), 12 month
Sub-study 2:
Data from 3 dimensional gait analysis(6 camara Vicon MX Motion Analysis system), including EMG analysis during gait.
Gait Deviation Index (GDI) was created to present gaitanalysis data in one score to give a comprehensive evaluation of the patients ambulation compared to healthy subjects. GDI is calculated from 15 kinematic variables, representing 98% of the variation in gait-patterns. A GDI score upon 100 represent normal gait. Every 10 points below this represent 1 standard deviation (SD) from normal gait.
Measured: Baseline, 3 month, and endpoint 12 month
Kinematic gait data, 12 month
Sub-study 2:
Data from 3 dimensional gait analysis(6 camara Vicon MX Motion Analysis system), including EMG analysis during gait.
Kinematic:
Sagittal hip Range of motion: extension/flexion. Frontal hip Range of motion: abduction/adduction. Frontal trunk inclination: left and right movement of the trunk.
Measured: Baseline, 3 month, and endpoint 12 month
Temporospatial parameters, 12 month
Sub-study 2:
Data from 3 dimensional gait analysis(6 camara Vicon MX Motion Analysis system), including EMG analysis during gait.
Temporospatial parameters:
Velocity. Cadance. Step duration. Stance duration
Measured: Baseline, 3 month, and endpoint 12 month
Electromyography (EMG) during walk, 12 month
Sub-study 2:
Data from 3 dimensional gait analysis(6 camara Vicon MX Motion Analysis system), including EMG analysis during gait.
Electromyography (EMG)during walk:
Peak EMG- in stance phase (absolute/normalized to MVC) Mean EMG- in stance phase (absolute/normalized to MVC) Integrated EMG during stancephase
Measured: Baseline, 3 month, and endpoint 12 month
Isometric maximal voluntary muscle contraction(MVC), 12 month
Sub-study 2:
Data from: Isometric maximal voluntary muscle contraction(MVC), including EMG analysis during test.
Maximal force (Fmax):
Hip Extension Flexion and Abduction. Rate of force development(RFD): Hip Extension. Flexion and Abduction
Measured: Baseline, 3 month, and endpoint 12 month
Limping question from Harris Hip Score
Primary study
Measured: Baseline, 3 month, 6 month and endpoint 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unilateral Primary Osteoarthritis of HipStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic department of Køge Hospital, Region Zealand, Region of Southern Denmark, University of Southern Denmark, The Danish Rheumatism Association, Bevica Fonden, Bjarne Jensens Fond
- Responsible party
- Principal investigator, Signe Rosenlund, MD, ph.d. student, Odense University Hospital
- Investigators
- Signe Rosenlund, MD, Principal investigator, Odense University Hospital and University of Southern DenmarkSøren Overgaard, MD, Professor, Study chair, Odense University Hospital and University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616667
- Sponsor's protocol ID
- S-20120009
- Other IDs
- A2116 Signe Rosenlund, 11/28589
- Acronym
- COMPALA
- Status last verified
- Jun 2015
- First submitted
- 30 May 2012
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenlund S, Broeng L, Overgaard S, Jensen C, Holsgaard-Larsen A. The efficacy of modified direct lateral versus posterior approach on gait function and hip muscle strength after primary total hip arthroplasty at 12months follow-up. An explorative randomised controlled trial. Clin Biomech (Bristol). 2016 Nov;39:91-99. doi: 10.1016/j.clinbiomech.2016.09.011. Epub 2016 Sep 30.
PubMed 27721093Rosenlund S, Broeng L, Jensen C, Holsgaard-Larsen A, Overgaard S. The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2014 Oct 27;15:354. doi: 10.1186/1471-2474-15-354.
PubMed 25345483
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Approach Versus Lateral Approach in Osteoarthritis Patients, With Primary Total Hip Arthroplasty. The Effect on Early Physical Function, Pain, Patient Reported Outcome Measures, Gait and Muscle Weakness A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01616667
- Acronym / sponsor ID
- COMPALA / S-20120009
- Conditions
- Unilateral Primary Osteoarthritis of Hip
- Keywords
- Controlled Clinical Trial, Operative Surgical Procedures, Treatment Outcome, Pain Measurement, Quality of Life, Questionnaires/standards, Activities of Daily Living, Biomechanics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Orthopaedic department of Køge Hospital, Region Zealand, Region of Southern Denmark, University of Southern Denmark, The Danish Rheumatism Association, Bevica Fonden, Bjarne Jensens Fond
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Jun 2012 (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 aim of this study is to investigate the clinical outcome of the two different, but widely used, surgical approaches (Posterior approach and Lateral approach) of primary total hip arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main study and two sub-studies. The main study investigates the patient-reported outcome measures (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the level of physical function and pain within the first 3 month after surgery, and ii) investigate the potential difference the two approaches have on gait-patterns and maximal isometric hip-muscle-strength, within the first year after surgery. Both approaches are described with potential drawbacks. Posterior approach has a higher risk of dislocation of the prostheses and revision due to dislocation compared with Lateral approach. Contrary, Lateral approach is described with the potential drawbacks of pain, lower physical function, gait abnormalities and muscle weakness, leading to less satisfied patients. However, according to a Cochrane analysis from 2004 concludes, more investigation is needed to determine the extent of differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified direct lateral approach | Active comparator | Procedure: Total hip arthroplastyThe patients included is operated with a total hip arthroplasty using a modified direct lateral approach |
| Posterior approach | Active comparator | Procedure: Total hip arthroplastyThe patients included is operated with a total hip arthroplasty using posterior approach |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 45-70 years, both included.
- Patients schedule for primary cementless total hip arthroplasty.
- Endstage hip osteoarthritis(OA) or minor dysplasia of the hip(CE-angle > 20 degrees).
Key exclusion criteria (10 listed)
- more major joint (hip or knee) than the current hip affected with OA, with expected joint replacement surgery within a year.
- Prior joint replacement surgery on any major joint (hip, knee) in lower limb.
- BMI above 35.
- Any physical disability that prevents patients from walking 20 meters without aid.
- The patients is not suitable for standard cementless prosthetic components.
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 |
|---|---|---|
| Total hip arthroplastyThe patients included is operated with a total hip arthroplasty due to primary osteoarthritis | Procedure or surgery | Modified direct lateral approach, Posterior approach |
Primary outcome
Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 12 month
Time frame: Endpoint 12 month
Primary study: Hip Disability and Osteoarthritis Outcome Score (HOOS) includes five subscales: 1)Pain 2) Other symptoms 3) Activities of daily living(ADL) 4) Sport and recreation function and 5) Hip related quality of life. HOOS-Physical Function Short form (HOOS-PS) is an aggregation and shortening of the two original subscales of HOOS-ADL and Sport and Recreation. HOOS-PS is a validated instrument. HOOS has been translated to Danish. We will use HOOS-PS as primary outcome.
18 secondary outcomes
Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month
Time frame: Baseline, 3 month, 6 month and endpoint 12 month
Hip Disability and Osteoarthritis Outcome Score (HOOS)-Hip related quality of life, 12 month
Time frame: Baseline, 3 month, 6 month and endpoint 12 month
University of California Los Angeles activity score (UCLA), 12 month
Time frame: Baseline, 3 month, 6 month and endpoint 12 month
EQ-5D self-rated health index -and EQ VAS scores, 12 month
Time frame: Baseline, 3 month, 6 month and endpoint 12 month
The 20 meter walk-test (20MeWa)
Time frame: Baseline, 3 days, 21 days and endpoint 3 month
"Timed Up and Go"- test (TUG), 3 month
Time frame: Baseline, 3 days, 21 days and endpoint 3 month
"Repeated chair rise"- test (RCR), 3 month
Time frame: Baseline, 3 days, 21 days and endpoint 3 month
30 seconds maximal repeated unilateral knee bending, 3 month
Time frame: Baseline, 3 days, 21 days and endpoint 3 month
Opioid consumption, 3 month
Time frame: Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
Self-reported pain on a numerical ranking scale(NRS), 3 month
Time frame: Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 3 month
Time frame: Baseline, 5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week
Hip Range of motion (ROM), 3 month
Time frame: Baseline and endpoint 3 month
Gait Deviation Index(GDI), 12 month
Time frame: Baseline, 3 month, and endpoint 12 month
Kinematic gait data, 12 month
Time frame: Baseline, 3 month, and endpoint 12 month
Temporospatial parameters, 12 month
Time frame: Baseline, 3 month, and endpoint 12 month
Electromyography (EMG) during walk, 12 month
Time frame: Baseline, 3 month, and endpoint 12 month
Isometric maximal voluntary muscle contraction(MVC), 12 month
Time frame: Baseline, 3 month, and endpoint 12 month
Limping question from Harris Hip Score
Time frame: Baseline, 3 month, 6 month and endpoint 12 month
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 4 Jun 2015.
- Derived from this study: PubMed 27721093Rosenlund S, Broeng L, Overgaard S, Jensen C, Holsgaard-Larsen A. The efficacy of modified direct lateral versus posterior approach on gait function and hip muscle strength after primary total hip arthroplasty at 12months follow-up. An explorative randomised controlled trial. Clin Biomech (Bristol). 2016 Nov;39:91-99. doi: 10.1016/j.clinbiomech.2016.09.011. Epub 2016 Sep 30.
- Derived from this study: PubMed 25345483Rosenlund S, Broeng L, Jensen C, Holsgaard-Larsen A, Overgaard S. The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2014 Oct 27;15:354. doi: 10.1186/1471-2474-15-354.
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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.
Signe Rosenlund, MD principal investigator
Odense University Hospital and University of Southern Denmark
Søren Overgaard, MD, Professor study chair
Odense University Hospital and University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Total hip arthroplasty in people with Unilateral Primary Osteoarthritis of Hip, run by Odense University Hospital at 1 site in Denmark.
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 10 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 4 Jun 2015. 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 12 month (time frame: Endpoint 12 month). 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 NCT01616667, which also lists 2 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 4 Jun 2015.