Hip FracturesFIRMNCT03430193
Fragility Fracture Integrated Rehabilitation Management (FIRM)
A study testing FIRM and Conventional rehabilitation in people with Hip Fractures, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures
- What is being tested?
- FIRM and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Feb 2018to 30 Sep 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture
- Type of surgery : Bipolar hemiarthroplasty, THA, ORIF
Who cannot join
- Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN
- Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor
- Combined multiple fracture (ex. Upper extremity)
- Revision operation
- Disagree to participation for clinical trial
- Severe cognitive dysfunction (Obey command ≤1)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Jae-Young Lim, MD, PhD, +82317877732, jaden.lim@gmail.com
Seung-Kyu Lim, MD, +821096045700, flyingmango77@gmail.com
About this study
Official title: Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients
A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility fracture integrated rehabilitation management (FIRM), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of FIRM compared to conventional rehabilitation.
Read the detailed description
The purpose of this prospective study
To develop a standardized fragility fracture integrated rehabilitation management (FIRM) based on the critical rehabilitation pathway for fragility fractures.
- Standardization of initial evaluation for fall and re-fracture risks before rehabilitation
- Standardization in initial screening for prevention for common complication after fracture and early diagnosis
- Evidence based standardization in rehabilitation after fragility fracture
- Development for safe return to normal daily life
- Conditions
- Hip Fractures
- Being tested
- FIRM, Conventional rehabilitation
- Keywords
- rehabilitation, multi-disciplinary rehabilitation, clinical pathway, Fragility
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIRMOther
FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward.
PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided.
Conventional rehabilitationOther
Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day.
| Study group | Role | What they receive |
|---|---|---|
| FIRM group | Experimental | FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward. PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided. Receives: Other: FIRM |
| Conventional group | Active comparator | Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day. Receives: Other: Conventional rehabilitation |
| No-rehabilitation group | No intervention | Discharged patients not transferred to rehabilitation unit after surgery for hip fracture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation
range, 0 to 5; decreasingly worse
Measured: 0, 3 month, 6 month, 12 month
Secondary outcomes (10)
Change from baselines mobility status (KOVAL) after rehabilitation
range, 1 to 7; increasingly worse
Measured: 0, 3 month, 6 month, 12 month
Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation
range, 1 to 7; decreasingly worse
Measured: 0, 3 month, 6 month, 12 month
Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation
range, 0 to 56; decreasingly worse
Measured: 0, 3 month, 6 month, 12 month
Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation
range, 0 to 30; decreasingly worse
Measured: 0, 3 month, 6 month, 12 month
Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation
range, 0 to 30 ; increasingly worse
Measured: 0, 3 month, 6 month, 12 month
Change from baselines Quality of life (Euro Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D)) after rehabilitation
range, 0 to 1; decreasingly worse
Measured: 0, 3 month, 6 month, 12 month
Change from baselines from activities of daily life (Korean modified Barthel index (K-MBI)) after rehabilitation
range, 0 to 100; decreasingly worse
Measured: 0, 3 month, 6 month, 12 month
Change from baselines from activities of daily life (Korean instrumental ADL (K-IADL)) after rehabilitation
range, 0 to 3; increasingly worse
Measured: 0, 3 month, 6 month, 12 month
Change from baselines frailty (Korean version of fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale) after rehabilitation
range, 0 to 5; increasingly worse
Measured: 0, 3 month, 6 month, 12 month
Change from baselines hand grip strength after rehabilitation
measured by a a digital dynamometer (TKK 5401 Grip-D; Takei, Niigata, Japan)
Measured: 0, 3 month, 6 month, 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 Feb 2018
- Study start12 Feb 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Jae-Young Lim, Seoul National University Bundang Hospital
- Investigators
- Jae-Young Lim, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430193
- Sponsor's protocol ID
- HC15C1189
- Acronym
- FIRM
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beaupre LA, Cinats JG, Senthilselvan A, Lier D, Jones CA, Scharfenberger A, Johnston DW, Saunders LD. Reduced morbidity for elderly patients with a hip fracture after implementation of a perioperative evidence-based clinical pathway. Qual Saf Health Care. 2006 Oct;15(5):375-9. doi: 10.1136/qshc.2005.017095.
PubMed 17074877Lyons AR. Clinical outcomes and treatment of hip fractures. Am J Med. 1997 Aug 18;103(2A):51S-63S; discussion 63S-64S. doi: 10.1016/s0002-9343(97)90027-9.
PubMed 9302897Magaziner J, Fredman L, Hawkes W, Hebel JR, Zimmerman S, Orwig DL, Wehren L. Changes in functional status attributable to hip fracture: a comparison of hip fracture patients to community-dwelling aged. Am J Epidemiol. 2003 Jun 1;157(11):1023-31. doi: 10.1093/aje/kwg081.
PubMed 12777366Sellier E, Labarere J, Sevestre MA, Belmin J, Thiel H, Couturier P, Bosson JL; Association pour la Promotion de l'Angiologie Hospitaliere. Risk factors for deep vein thrombosis in older patients: a multicenter study with systematic compression ultrasonography in postacute care facilities in France. J Am Geriatr Soc. 2008 Feb;56(2):224-30. doi: 10.1111/j.1532-5415.2007.01545.x. Epub 2007 Dec 7.
PubMed 18070003Hannan EL, Magaziner J, Wang JJ, Eastwood EA, Silberzweig SB, Gilbert M, Morrison RS, McLaughlin MA, Orosz GM, Siu AL. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes. JAMA. 2001 Jun 6;285(21):2736-42. doi: 10.1001/jama.285.21.2736.
PubMed 11386929Siu AL, Penrod JD, Boockvar KS, Koval K, Strauss E, Morrison RS. Early ambulation after hip fracture: effects on function and mortality. Arch Intern Med. 2006 Apr 10;166(7):766-71. doi: 10.1001/archinte.166.7.766.
PubMed 16606814Koval KJ, Cooley MR. Clinical pathway after hip fracture. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1053-60. doi: 10.1080/09638280500056618.
PubMed 16278174Halbert J, Crotty M, Whitehead C, Cameron I, Kurrle S, Graham S, Handoll H, Finnegan T, Jones T, Foley A, Shanahan M; Hip Fracture Rehabilitation Trial Collaborative Group. Multi-disciplinary rehabilitation after hip fracture is associated with improved outcome: A systematic review. J Rehabil Med. 2007 Sep;39(7):507-12. doi: 10.2340/16501977-0102.
PubMed 17724548Adunsky A, Lusky A, Arad M, Heruti RJ. A comparative study of rehabilitation outcomes of elderly hip fracture patients: the advantage of a comprehensive orthogeriatric approach. J Gerontol A Biol Sci Med Sci. 2003 Jun;58(6):542-7. doi: 10.1093/gerona/58.6.m542.
PubMed 12807926Lim SK, Lim JY. Nutritional status modifies the effect of rehabilitation strategy on functional recovery after hip fracture in older adults. Maturitas. 2026 Aug;211:109008. doi: 10.1016/j.maturitas.2026.109008. Epub 2026 Jun 2.
PubMed 42250394Lee SY, Beom J, Kim BR, Lim SK, Lim JY; Fragility Fracture Rehabilitation Study Group. Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial. Medicine (Baltimore). 2018 May;97(20):e10763. doi: 10.1097/MD.0000000000010763.
PubMed 29768364
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients
- ClinicalTrials.gov ID
- NCT03430193
- Acronym / sponsor ID
- FIRM / HC15C1189
- Conditions
- Hip Fractures
- Keywords
- rehabilitation, multi-disciplinary rehabilitation, clinical pathway, Fragility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 12 Feb 2018 (actual)
- 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.
A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility fracture integrated rehabilitation management (FIRM), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of FIRM compared to conventional rehabilitation.
Detailed description
The purpose of this prospective study
To develop a standardized fragility fracture integrated rehabilitation management (FIRM) based on the critical rehabilitation pathway for fragility fractures.
- Standardization of initial evaluation for fall and re-fracture risks before rehabilitation
- Standardization in initial screening for prevention for common complication after fracture and early diagnosis
- Evidence based standardization in rehabilitation after fragility fracture
- Development for safe return to normal daily life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FIRM group | Experimental | Other: FIRMFIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward. PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided. |
| Conventional group | Active comparator | Other: Conventional rehabilitationConventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day. |
| No-rehabilitation group | No intervention | –Discharged patients not transferred to rehabilitation unit after surgery for hip fracture. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture
- Type of surgery : Bipolar hemiarthroplasty, THA, ORIF
Key exclusion criteria (6 listed)
- Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN
- Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor
- Combined multiple fracture (ex. Upper extremity)
- Revision operation
- Disagree to participation for clinical trial
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 |
|---|---|---|
| FIRMFIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward. PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided. | Other | FIRM group |
| Conventional rehabilitationConventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day. | Other | Conventional group |
Primary outcome
Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
range, 0 to 5; decreasingly worse
10 secondary outcomes
Change from baselines mobility status (KOVAL) after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
Change from baselines Quality of life (Euro Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D)) after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
Change from baselines from activities of daily life (Korean modified Barthel index (K-MBI)) after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
Change from baselines from activities of daily life (Korean instrumental ADL (K-IADL)) after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
Change from baselines frailty (Korean version of fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale) after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
Change from baselines hand grip strength after rehabilitation
Time frame: 0, 3 month, 6 month, 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Background: PubMed 17074877Beaupre LA, Cinats JG, Senthilselvan A, Lier D, Jones CA, Scharfenberger A, Johnston DW, Saunders LD. Reduced morbidity for elderly patients with a hip fracture after implementation of a perioperative evidence-based clinical pathway. Qual Saf Health Care. 2006 Oct;15(5):375-9. doi: 10.1136/qshc.2005.017095.
- Results publication: PubMed 9302897Lyons AR. Clinical outcomes and treatment of hip fractures. Am J Med. 1997 Aug 18;103(2A):51S-63S; discussion 63S-64S. doi: 10.1016/s0002-9343(97)90027-9.
- Results publication: PubMed 12777366Magaziner J, Fredman L, Hawkes W, Hebel JR, Zimmerman S, Orwig DL, Wehren L. Changes in functional status attributable to hip fracture: a comparison of hip fracture patients to community-dwelling aged. Am J Epidemiol. 2003 Jun 1;157(11):1023-31. doi: 10.1093/aje/kwg081.
- Results publication: PubMed 18070003Sellier E, Labarere J, Sevestre MA, Belmin J, Thiel H, Couturier P, Bosson JL; Association pour la Promotion de l'Angiologie Hospitaliere. Risk factors for deep vein thrombosis in older patients: a multicenter study with systematic compression ultrasonography in postacute care facilities in France. J Am Geriatr Soc. 2008 Feb;56(2):224-30. doi: 10.1111/j.1532-5415.2007.01545.x. Epub 2007 Dec 7.
- Results publication: PubMed 11386929Hannan EL, Magaziner J, Wang JJ, Eastwood EA, Silberzweig SB, Gilbert M, Morrison RS, McLaughlin MA, Orosz GM, Siu AL. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes. JAMA. 2001 Jun 6;285(21):2736-42. doi: 10.1001/jama.285.21.2736.
- Results publication: PubMed 16606814Siu AL, Penrod JD, Boockvar KS, Koval K, Strauss E, Morrison RS. Early ambulation after hip fracture: effects on function and mortality. Arch Intern Med. 2006 Apr 10;166(7):766-71. doi: 10.1001/archinte.166.7.766.
- Results publication: PubMed 16278174Koval KJ, Cooley MR. Clinical pathway after hip fracture. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1053-60. doi: 10.1080/09638280500056618.
- Results publication: PubMed 17724548Halbert J, Crotty M, Whitehead C, Cameron I, Kurrle S, Graham S, Handoll H, Finnegan T, Jones T, Foley A, Shanahan M; Hip Fracture Rehabilitation Trial Collaborative Group. Multi-disciplinary rehabilitation after hip fracture is associated with improved outcome: A systematic review. J Rehabil Med. 2007 Sep;39(7):507-12. doi: 10.2340/16501977-0102.
- Results publication: PubMed 12807926Adunsky A, Lusky A, Arad M, Heruti RJ. A comparative study of rehabilitation outcomes of elderly hip fracture patients: the advantage of a comprehensive orthogeriatric approach. J Gerontol A Biol Sci Med Sci. 2003 Jun;58(6):542-7. doi: 10.1093/gerona/58.6.m542.
- Derived from this study: PubMed 42250394Lim SK, Lim JY. Nutritional status modifies the effect of rehabilitation strategy on functional recovery after hip fracture in older adults. Maturitas. 2026 Aug;211:109008. doi: 10.1016/j.maturitas.2026.109008. Epub 2026 Jun 2.
- Derived from this study: PubMed 29768364Lee SY, Beom J, Kim BR, Lim SK, Lim JY; Fragility Fracture Rehabilitation Study Group. Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial. Medicine (Baltimore). 2018 May;97(20):e10763. doi: 10.1097/MD.0000000000010763.
- Individual participant dataSharing planned: No
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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.
Jae-Young Lim, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIRM and Conventional rehabilitation in people with Hip Fractures, run by Seoul National University Bundang Hospital at 1 site 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 2 inclusion and 6 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 15 Jan 2021. 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 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 Seung-Kyu Lim, MD (+821096045700, flyingmango77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation (time frame: 0, 3 month, 6 month, 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 NCT03430193, which also lists 11 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 15 Jan 2021.