Ankle FractureNCT02029170
Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture
A study testing Early weightbearing and Non-weightbearing in people with Ankle Fracture and Rehabilitation, run by Hallym University Medical Center at 4 sites in South Korea.
Trial summary
Unstable ankle fractures are commonly treated operatively. After operative reduction and fixation of the fractures, there are varying rehabilitation regimes that include non-weightbearing for 6 weeks with active range of motion exercise in a removal cast or brace, or early protected weightbearing in a rigid cast. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fracture, Rehabilitation
- What is being tested?
- Early weightbearing and Non-weightbearing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Jan 2014to Jan 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unstable ankle fracture requiring open reduction and internal fixation
- age between 18 and 65 years
- satisfactory reduction and stable fixation after operation.
Who cannot join
- open fractures
- comminuted fractures
- pathologic fractures
- Pilon fractures
- Trimalleolar fractures
- fracture dislocations
Show all 11Show fewer
- Fractures requiring syndesmotic screw fixation
- Fractures with cartilage injuries or unstable fixation or any other conditions preventing from early weightbearing.
- Patients with diabetes or neuroarthropathy
- Patients with obesity (BMI >30, weight >100 kg)
- Any other conditions that are expected to prevent the patients from following the study protocol
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Hallym University Sacred Heart Hospital, Hallym University College of Medicine
Anyang-si, Gyeonggi-do, 431-070
Jae Yong Park, MD, +82-31-380-1500, getfours@gmail.com
Jae Yong Park, MD
- Recruiting
Sanbon Hospital, Wonkwang University College of Medicine
Gunpo, Gyeongi, 435-040
Yu Mi Kim, MD, PhD, +82-31-390-2224, castkim@hanmail.net
Yu Mi Kim, MD, PhD
- Recruiting
CHA Bundang Medical Center, CHA University
Seongnam, Gyeongi, 463-712
Young Rak Choi, MD, +82-31-780-5289, jeanguy@hanmail.net
- Recruiting
Kangnam Sacred Heart Hospital, Hallym University College of Medicine
Seoul, 150-950
Hyong Nyun Kim, MD, PhD, +82-10-6377-8201, hyongnyun@naver.com
Hyong Nyun Kim, MD, PhD
About this study
Official title: Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture: A Randomized Multicenter Non-inferiority Trial
Unstable ankle fractures are commonly treated operatively. After operative reduction and fixation of the fractures, there are varying rehabilitation regimes that include non-weightbearing for 6 weeks with active range of motion exercise in a removal cast or brace, or early protected weightbearing in a rigid cast. Several papers reported that early weightbearing may decrease ankle stiffness, muscle and bone atrophy, and aids in early return to activities. However, early weightbearing may have the risk of displacement of the fixed fractures. Rehabilitation after operative treatment of an ankle fracture is still not clear. We hypothesized that the ankle function assessed on 12 months after operation of an ankle fracture with early weightbearing is not inferior to non-weightbearing but is superior to non-weightbearing with respect to time to return to normal daily life and time to full weightbearing.
Read the detailed description
This study is a noninferiority, randomized controlled trial of patients presenting to multiple centers.
The primary outcome measure is the Olerud-Molander scores assess on 12 months after operation of an unstable ankle fracture. The Olerud-Molander scores were compared between the experimental group (early weightbearing) and the control group (non-weightbearing) on 12 month follow-up examination.
The Olerud-Molander score is a most widely used validated scale to assess ankle function after an ankle fracture. It is a self-administered patient questionnaire with a score of zero (totally impaired) to 100 (completely unimpaired) and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living.
The secondary objectives are to determine whether early weightbearing is superior to non-weightbearing with respect to time until return to normal daily life and time to full weightbearing.
Other objectives are to determine safety by assessing number of participants with adverse effect such as hardware failure, reduction loss, non-union, or delayed union in each group.
The sample size was determined using methods appropriate for noninferiority trials, assuming 90% power and a significance level of 0.05. To find out whether the early weightbearing is not inferior to nonweightbearing after operation of an ankle fracture, 192 patients were required to have 90% power that the lower limit of an one-sided 95% confidence interval for the difference between two treatments will be above the noninferiority margin of -8, adding 20% of assumed drop-out.
Determination of the noninferiority margin was based on clinical significance. In a previous study between early weightbearing versus nonweightbearing after an ankle fracture surgery, Simanski et al. reported that both groups showed good results in the Olerud-Molander score (87 vs. 79 points; p=0.25). In both groups, the majority of patients reached their preinjury level of activity. The difference in the Olerud-Molander score between the two groups was 8 points in favor of early weightbearing. Their study came from populations similar to our trial population and from interventions similar to those being studied in the current trial. We decided that the noninferiority margin at 8 points difference will be adequate to prove noninferiority of the experiment group (early weightbearing) over the control group (nonweightbearing).
If a subject had discontinued prior to completion of 12 months, the last observation is carried forward for the intent-to-treat analysis. Subjects who crossed over to the other treatment arm, for an example, patients in non-weightbearing group who weightbear early, are analyzed according to their initial group allocation for the intent-to-treat analysis. Additionally, an as-treated (per-protocal) analysis was also conducted on patients who completed the 12 months follow-up with the protocol assigned.
- Conditions
- Ankle Fracture, Rehabilitation
- Being tested
- Early weightbearing, Non-weightbearing
- Keywords
- ankle fracture, weightbearing, cast
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early weightbearingProcedure or surgery
Patients allocated to early weightbearing group are allowed to weightbear after stitch out and application of a walking cast
Non-weightbearingProcedure or surgery
Patients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative
| Study group | Role | What they receive |
|---|---|---|
| Early weightbearing | Experimental | After operative reduction and fixation of the fractures, patients allocated to the early weightbearing group start weightbearing after stitch out at 2 weeks and the application of a walking cast. Receives: Procedure: Early weightbearing |
| Non-weightbearing | Active comparator | Patients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative Receives: Procedure: Non-weightbearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Olerud-Molander ankle function score
The Olerud-Molander score is a most widely used validated scale to assess ankle function after an ankle fracture. It is a self-administered patient questionnaire with a score of zero (totally impaired) to 100 (completely unimpaired) and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living.
Measured: 12 months post-operative
Secondary outcomes (1)
Time to return to preinjury activity, time to full weightbearing, patients' subjective satisfactions, Visual analogue Scale (VAS)
Time to return to preinjury activity and time to full weightbearing is going to be assessed.
Patient's subjective satisfaction and VAS are going to be assessed on 12 months post-operative visit
Measured: upto 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Ankle FractureStudies 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
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyong Nyun Kim, Hallym University Medical Center
- Investigators
- Hyong Nyun Kim, MD, PhD, Study chair, Kangnam Sacred Heart Hospital, Hallym University College of MedicineHyong Nyun Kim, MD, PhD, Study director, Kangnam Sacred Heart Hospital, Hallym University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029170
- Sponsor's protocol ID
- HUKSHHOS
- Status last verified
- Oct 2015
- First submitted
- 6 Jan 2014
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahl T, Dalen N, Holmberg S, Selvik G. Early weight bearing of displaced ankle fractures. Acta Orthop Scand. 1987 Oct;58(5):535-8. doi: 10.3109/17453678709146394.
PubMed 3425284Aktas S, Kocaoglu B, Gereli A, Nalbantodlu U, Guven O. Incidence of chondral lesions of talar dome in ankle fracture types. Foot Ankle Int. 2008 Mar;29(3):287-92. doi: 10.3113/FAI.2008.0287.
PubMed 18348824Bostman OM. Body-weight related to loss of reduction of fractures of the distal tibia and ankle. J Bone Joint Surg Br. 1995 Jan;77(1):101-3.
PubMed 7822361Burwell HN, Charnley AD. The treatment of displaced fractures at the ankle by rigid internal fixation and early joint movement. J Bone Joint Surg Br. 1965 Nov;47(4):634-60. No abstract available.
PubMed 5846764Dogra AS, Rangan A. Early mobilisation versus immobilisation of surgically treated ankle fractures. Prospective randomised control trial. Injury. 1999 Aug;30(6):417-9. doi: 10.1016/s0020-1383(99)00110-2.
PubMed 10645355Finsen V, Saetermo R, Kibsgaard L, Farran K, Engebretsen L, Bolz KD, Benum P. Early postoperative weight-bearing and muscle activity in patients who have a fracture of the ankle. J Bone Joint Surg Am. 1989 Jan;71(1):23-7.
PubMed 2492286Ganesh SP, Pietrobon R, Cecilio WA, Pan D, Lightdale N, Nunley JA. The impact of diabetes on patient outcomes after ankle fracture. J Bone Joint Surg Am. 2005 Aug;87(8):1712-8. doi: 10.2106/JBJS.D.02625.
PubMed 16085609Lehtonen H, Jarvinen TL, Honkonen S, Nyman M, Vihtonen K, Jarvinen M. Use of a cast compared with a functional ankle brace after operative treatment of an ankle fracture. A prospective, randomized study. J Bone Joint Surg Am. 2003 Feb;85(2):205-11. doi: 10.2106/00004623-200302000-00004.
PubMed 12571295Mak KH, Chan KM, Leung PC. Ankle fracture treated with the AO principle--an experience with 116 cases. Injury. 1985 Jan;16(4):265-72. doi: 10.1016/s0020-1383(85)80017-6.
PubMed 3967916Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.
PubMed 6437370Pagliaro AJ, Michelson JD, Mizel MS. Results of operative fixation of unstable ankle fractures in geriatric patients. Foot Ankle Int. 2001 May;22(5):399-402. doi: 10.1177/107110070102200507.
PubMed 11428758Simanski CJ, Maegele MG, Lefering R, Lehnen DM, Kawel N, Riess P, Yucel N, Tiling T, Bouillon B. Functional treatment and early weightbearing after an ankle fracture: a prospective study. J Orthop Trauma. 2006 Feb;20(2):108-14. doi: 10.1097/01.bot.0000197701.96954.8c.
PubMed 16462563Starkweather MP, Collman DR, Schuberth JM. Early protected weightbearing after open reduction internal fixation of ankle fractures. J Foot Ankle Surg. 2012 Sep-Oct;51(5):575-8. doi: 10.1053/j.jfas.2012.05.022. Epub 2012 Jul 20.
PubMed 22819002Strauss EJ, Frank JB, Walsh M, Koval KJ, Egol KA. Does obesity influence the outcome after the operative treatment of ankle fractures? J Bone Joint Surg Br. 2007 Jun;89(6):794-8. doi: 10.1302/0301-620X.89B6.18356.
PubMed 17613507Tropp H, Norlin R. Ankle performance after ankle fracture: a randomized study of early mobilization. Foot Ankle Int. 1995 Feb;16(2):79-83. doi: 10.1177/107110079501600205.
PubMed 7767451
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture: A Randomized Multicenter Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02029170
- Acronym / sponsor ID
- HUKSHHOS
- Conditions
- Ankle Fracture, Rehabilitation
- Keywords
- ankle fracture, weightbearing, cast
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 7 Jan 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.
Unstable ankle fractures are commonly treated operatively. After operative reduction and fixation of the fractures, there are varying rehabilitation regimes that include non-weightbearing for 6 weeks with active range of motion exercise in a removal cast or brace, or early protected weightbearing in a rigid cast. Several papers reported that early weightbearing may decrease ankle stiffness, muscle and bone atrophy, and aids in early return to activities. However, early weightbearing may have the risk of displacement of the fixed fractures. Rehabilitation after operative treatment of an ankle fracture is still not clear. We hypothesized that the ankle function assessed on 12 months after operation of an ankle fracture with early weightbearing is not inferior to non-weightbearing but is superior to non-weightbearing with respect to time to return to normal daily life and time to full weightbearing.
Detailed description
This study is a noninferiority, randomized controlled trial of patients presenting to multiple centers.
The primary outcome measure is the Olerud-Molander scores assess on 12 months after operation of an unstable ankle fracture. The Olerud-Molander scores were compared between the experimental group (early weightbearing) and the control group (non-weightbearing) on 12 month follow-up examination.
The Olerud-Molander score is a most widely used validated scale to assess ankle function after an ankle fracture. It is a self-administered patient questionnaire with a score of zero (totally impaired) to 100 (completely unimpaired) and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living.
The secondary objectives are to determine whether early weightbearing is superior to non-weightbearing with respect to time until return to normal daily life and time to full weightbearing.
Other objectives are to determine safety by assessing number of participants with adverse effect such as hardware failure, reduction loss, non-union, or delayed union in each group.
The sample size was determined using methods appropriate for noninferiority trials, assuming 90% power and a significance level of 0.05. To find out whether the early weightbearing is not inferior to nonweightbearing after operation of an ankle fracture, 192 patients were required to have 90% power that the lower limit of an one-sided 95% confidence interval for the difference between two treatments will be above the noninferiority margin of -8, adding 20% of assumed drop-out.
Determination of the noninferiority margin was based on clinical significance. In a previous study between early weightbearing versus nonweightbearing after an ankle fracture surgery, Simanski et al. reported that both groups showed good results in the Olerud-Molander score (87 vs. 79 points; p=0.25). In both groups, the majority of patients reached their preinjury level of activity. The difference in the Olerud-Molander score between the two groups was 8 points in favor of early weightbearing. Their study came from populations similar to our trial population and from interventions similar to those being studied in the current trial. We decided that the noninferiority margin at 8 points difference will be adequate to prove noninferiority of the experiment group (early weightbearing) over the control group (nonweightbearing).
If a subject had discontinued prior to completion of 12 months, the last observation is carried forward for the intent-to-treat analysis. Subjects who crossed over to the other treatment arm, for an example, patients in non-weightbearing group who weightbear early, are analyzed according to their initial group allocation for the intent-to-treat analysis. Additionally, an as-treated (per-protocal) analysis was also conducted on patients who completed the 12 months follow-up with the protocol assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early weightbearing | Experimental | Procedure: Early weightbearingAfter operative reduction and fixation of the fractures, patients allocated to the early weightbearing group start weightbearing after stitch out at 2 weeks and the application of a walking cast. |
| Non-weightbearing | Active comparator | Procedure: Non-weightbearingPatients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- unstable ankle fracture requiring open reduction and internal fixation
- age between 18 and 65 years
- satisfactory reduction and stable fixation after operation.
Key exclusion criteria (11 listed)
- open fractures
- comminuted fractures
- pathologic fractures
- Pilon fractures
- Trimalleolar fractures
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 |
|---|---|---|
| Early weightbearingPatients allocated to early weightbearing group are allowed to weightbear after stitch out and application of a walking cast | Procedure or surgery | Early weightbearing |
| Non-weightbearingPatients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative | Procedure or surgery | Non-weightbearing |
Primary outcome
The Olerud-Molander ankle function score
Time frame: 12 months post-operative
The Olerud-Molander score is a most widely used validated scale to assess ankle function after an ankle fracture. It is a self-administered patient questionnaire with a score of zero (totally impaired) to 100 (completely unimpaired) and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living.
1 secondary outcome
Time to return to preinjury activity, time to full weightbearing, patients' subjective satisfactions, Visual analogue Scale (VAS)
Time frame: upto 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Background: PubMed 3425284Ahl T, Dalen N, Holmberg S, Selvik G. Early weight bearing of displaced ankle fractures. Acta Orthop Scand. 1987 Oct;58(5):535-8. doi: 10.3109/17453678709146394.
- Background: PubMed 18348824Aktas S, Kocaoglu B, Gereli A, Nalbantodlu U, Guven O. Incidence of chondral lesions of talar dome in ankle fracture types. Foot Ankle Int. 2008 Mar;29(3):287-92. doi: 10.3113/FAI.2008.0287.
- Background: PubMed 7822361Bostman OM. Body-weight related to loss of reduction of fractures of the distal tibia and ankle. J Bone Joint Surg Br. 1995 Jan;77(1):101-3.
- Background: PubMed 5846764Burwell HN, Charnley AD. The treatment of displaced fractures at the ankle by rigid internal fixation and early joint movement. J Bone Joint Surg Br. 1965 Nov;47(4):634-60. No abstract available.
- Background: PubMed 10645355Dogra AS, Rangan A. Early mobilisation versus immobilisation of surgically treated ankle fractures. Prospective randomised control trial. Injury. 1999 Aug;30(6):417-9. doi: 10.1016/s0020-1383(99)00110-2.
- Background: PubMed 2492286Finsen V, Saetermo R, Kibsgaard L, Farran K, Engebretsen L, Bolz KD, Benum P. Early postoperative weight-bearing and muscle activity in patients who have a fracture of the ankle. J Bone Joint Surg Am. 1989 Jan;71(1):23-7.
- Background: PubMed 16085609Ganesh SP, Pietrobon R, Cecilio WA, Pan D, Lightdale N, Nunley JA. The impact of diabetes on patient outcomes after ankle fracture. J Bone Joint Surg Am. 2005 Aug;87(8):1712-8. doi: 10.2106/JBJS.D.02625.
- Background: PubMed 12571295Lehtonen H, Jarvinen TL, Honkonen S, Nyman M, Vihtonen K, Jarvinen M. Use of a cast compared with a functional ankle brace after operative treatment of an ankle fracture. A prospective, randomized study. J Bone Joint Surg Am. 2003 Feb;85(2):205-11. doi: 10.2106/00004623-200302000-00004.
- Background: PubMed 3967916Mak KH, Chan KM, Leung PC. Ankle fracture treated with the AO principle--an experience with 116 cases. Injury. 1985 Jan;16(4):265-72. doi: 10.1016/s0020-1383(85)80017-6.
- Background: PubMed 6437370Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.
- Background: PubMed 11428758Pagliaro AJ, Michelson JD, Mizel MS. Results of operative fixation of unstable ankle fractures in geriatric patients. Foot Ankle Int. 2001 May;22(5):399-402. doi: 10.1177/107110070102200507.
- Background: PubMed 16462563Simanski CJ, Maegele MG, Lefering R, Lehnen DM, Kawel N, Riess P, Yucel N, Tiling T, Bouillon B. Functional treatment and early weightbearing after an ankle fracture: a prospective study. J Orthop Trauma. 2006 Feb;20(2):108-14. doi: 10.1097/01.bot.0000197701.96954.8c.
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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.
Hyong Nyun Kim, MD, PhD study chair
Kangnam Sacred Heart Hospital, Hallym University College of Medicine
Hyong Nyun Kim, MD, PhD study director
Kangnam Sacred Heart Hospital, Hallym University College of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early weightbearing and Non-weightbearing in people with Ankle Fracture and Rehabilitation, run by Hallym University Medical Center at 4 sites in South Korea.
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 11 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 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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 Hyong Nyun Kim, MD, PhD (+82-10-6377-8201, hyongnyun@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Olerud-Molander ankle function score (time frame: 12 months post-operative). 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 NCT02029170, which also lists 17 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 9 Oct 2015.