Total Hip ReplacementReHip2NCT03833258
Unrestricted Rehabilitation Pathway Following Total Hip Replacement
A study testing Rehabilitation with no precautions in people with Total Hip Replacement, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
The purpose of ReHip2 is to explore the impact on function and quality of life in patients following Total Hip Replacement (THR). A randomised controlled trial will compare two different rehabilitation pathways following surgery (Routine care with precautions and Treatment group with no precautions). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Rehabilitation with no precautions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 22 Aug 2019to 30 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants over the age of 18 years will be included.
- All participants should be proceeding with routine care unilateral (one side only) primary THR for treatment of osteoarthritis
- The patients operating consultant agreed to involvement of their patients in the study.
- All subjects assessed during routine pre-operative assessment in their respective hospital will have been assigned an American Society of Anesthesiologists (ASA) up to grade 3 out of a total of 6 (defined as 'severe systemic disease that limits activity but is not incapacitating').
- Patients who have undergone previous hip injection for treatment of osteoarthritic symptoms.
- All surgical approaches (anterior, lateral and posterior), cemented and un-cemented prostheses and all size femoral head size.
Who cannot join
- The operating consultant declined participation in the study.
- The participant previously had hip surgery to the same hip, including arthroscopy, revision hip surgery or treatment for Avascular Necrosis.
- ASA grade 4 or above 'A patient with severe systemic disease that is a constant threat to life.'
- Patients with specifically identified increased risk of dislocation (for example neuromuscular disease, hypermobility)
- Complex primary hip replacement (THR with femoral osteotomy or structural bone grafting / augmentation of acetabulum)
- Patients unable to complete the postal outcome measures.
- Any patient with pre-operative cognitive impairment (Dementia or Learning disabilities).
- Patients undergoing THR for treatment of fractured neck of femur.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Wrightington Wigan and Leigh NHS Foundation Trust
Wigan, WN6 9EP
About this study
Official title: A Randomised Controlled Trial of the Impact on Function of an Unrestricted Rehabilitation Pathway of no Precautions Following Total Hip Replacement
The purpose of ReHip2 is to explore the impact on function and quality of life in patients following Total Hip Replacement (THR). A randomised controlled trial will compare two different rehabilitation pathways following surgery (Routine care with precautions and Treatment group with no precautions). The proposal is to carry out the RCT with a minimum of 182 patients based in the UK.
Read the detailed description
Dislocation of the hip following total hip replacement (THR) is the sole reason for the endorsement of precautions following THR. This has remained unchanged sine the first hip replacement in 1969.
The precautions are;
- Patients must not bend past 90 degrees at the hip (including sitting)
- Patients must not twist in either standing or sitting
- Patients must partial weight bear with elbow crutches for a minimum of 6 weeks
- Patients must sleep on their back for a minimum of 6 weeks
- Patients must not cross their legs
Studies exploring factors affecting dislocation following THR identified three main influences: surgical technique, type of prosthesis and post-operative precautions. A number of studies have challenged the continued use of precautions or explored their impact on dislocation. However, these studies did not fully consider the impact of all precautions on dislocation, choosing to only select elements of the precautions for investigation. A recent review concluded the evidence evaluating practice and the impact of precautions was of poor quality. The review suggested further research should take into account different surgical approaches, different femoral head sizes and the type of prosthesis. Although there are studies that explored some of these hip dislocation confounders, the true impact of precautions remains unknown.
Whilst precautions continue to be endorsed by surgeons and other clinicians, previous challenges have raised awareness of the possible excessiveness of precautions and the importance of further robust work recommended. This is particularly so in the wake of developments in surgical technique and prostheses design, such as hip joint capsule repair and larger femoral head sizes (larger hip replacements). These developments and their impact on dislocation are beginning to cast doubt on the impact of post-operative precautions and their direct link to incidence of dislocation, which is their primary purpose.
The imposition of precautions has been evidenced to impact on both function and quality of life, with resultant non adherence in a proportion of patients. This study intends to explore whether an unrestricted pathway has no worse outcome in function, pain and quality of life parameters, in two specialist units in a multi-centre, prospective, randomised, non-inferiority study.
- Conditions
- Total Hip Replacement
- Being tested
- Rehabilitation with no precautions
- Keywords
- THR, THA, Total Hip Arthroplasty, Total Hip Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation with no precautionsBehavioural
Patients will recover from total hip replacement surgery being guided by pain only and not by the precautions imposed upon them by clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation with precautions | No intervention | Patients in this arm will continue with rehabilitation following routine care recommendations after total hip replacement; therefore following precautions. |
| Rehabilitation with no precautions | Experimental | Patients in this arm will continue with rehabilitation after total hip replacement without precautions, being permitted to move within limits of their own pain only. Receives: Behavioral: Rehabilitation with no precautions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Hip Score (OHS)
Consists of 12 items measuring pain, activity, joint mobility and ambulatory activity using a 5 point ordinal Likert Scale over the previous 4 weeks. The total score for the OHS range from 12-60 with the lowest score of 12 signifying the least limited function and the highest score of 60 signifying the most limited function.
Measured: assessed at baseline, 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
Secondary outcomes (2)
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is an outcome measure designed to assess sleep quality, disturbance and impact on function over the preceding one month. The PSQI measures seven categories. Scores total greater than 5 indicate clinically meaningfully disturbed sleep or poor sleep, less than 4 indicates no problems with sleep
Measured: assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
EQ-5D-L
The lowest score of 0 indicates no functional impairment and a score of 4 indicates significant impairment. The category responses are not combined.
Using a continuous scale on a 20cm vertical visual analogue scale (VAS) a score of 100 means 'the best health imaginable and a score of 0 means 'the worst health imaginable.' EQ5DL Scores at different timepoints are compared to show changes in health over time
Measured: assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start22 Aug 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Why it stopped: COVID 19 resulted in cancellation of all elective surgery therefore we need to terminate the trial with 95 participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justine Theaker, University of Manchester
- Investigators
- JACQUELINE OLDHAM, Study chair, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833258
- Sponsor's protocol ID
- NHS001514
- Acronym
- ReHip2
- Status last verified
- Nov 2022
- First submitted
- 5 Feb 2019
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blom AW, Rogers M, Taylor AH, Pattison G, Whitehouse S, Bannister GC. Dislocation following total hip replacement: the Avon Orthopaedic Centre experience. Ann R Coll Surg Engl. 2008 Nov;90(8):658-62. doi: 10.1308/003588408X318156. Epub 2008 Sep 30.
PubMed 18828962Berry DJ, von Knoch M, Schleck CD, Harmsen WS. Effect of femoral head diameter and operative approach on risk of dislocation after primary total hip arthroplasty. J Bone Joint Surg Am. 2005 Nov;87(11):2456-63. doi: 10.2106/JBJS.D.02860.
PubMed 16264121Berry DJ, von Knoch M, Schleck CD, Harmsen WS. The cumulative long-term risk of dislocation after primary Charnley total hip arthroplasty. J Bone Joint Surg Am. 2004 Jan;86(1):9-14. doi: 10.2106/00004623-200401000-00003.
PubMed 14711939Charnley J. Total hip replacement by low-friction arthroplasty. Clin Orthop Relat Res. 1970 Sep-Oct;72:7-21. No abstract available.
PubMed 5459811Smith TO, Jepson P, Beswick A, Sands G, Drummond A, Davis ET, Sackley CM. Assistive devices, hip precautions, environmental modifications and training to prevent dislocation and improve function after hip arthroplasty. Cochrane Database Syst Rev. 2016 Jul 4;7(7):CD010815. doi: 10.1002/14651858.CD010815.pub2.
PubMed 27374001Ververeli PA, Lebby EB, Tyler C, Fouad C. Evaluation of reducing postoperative hip precautions in total hip replacement: a randomized prospective study. Orthopedics. 2009 Dec;32(12):889. doi: 10.3928/01477447-20091020-09.
PubMed 19968217Restrepo C, Mortazavi SM, Brothers J, Parvizi J, Rothman RH. Hip dislocation: are hip precautions necessary in anterior approaches? Clin Orthop Relat Res. 2011 Feb;469(2):417-22. doi: 10.1007/s11999-010-1668-y.
PubMed 21076896Soong M, Rubash HE, Macaulay W. Dislocation after total hip arthroplasty. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):314-21. doi: 10.5435/00124635-200409000-00006.
PubMed 15469226Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009 Jun;467(6):1400-11. doi: 10.1007/s11999-009-0750-9. Epub 2009 Mar 10.
PubMed 19277807Mikkelsen LR, Petersen MK, Soballe K, Mikkelsen S, Mechlenburg I. Does reduced movement restrictions and use of assistive devices affect rehabilitation outcome after total hip replacement? A non-randomized, controlled study. Eur J Phys Rehabil Med. 2014 Aug;50(4):383-93. Epub 2014 Jan 30.
PubMed 24476806Duwelius PJ, Burkhart RL, Hayhurst JO, Moller H, Butler JB. Comparison of the 2-incision and mini-incision posterior total hip arthroplasty technique: a retrospective match-pair controlled study. J Arthroplasty. 2007 Jan;22(1):48-56. doi: 10.1016/j.arth.2006.09.012.
PubMed 17197308Jolles BM, Bogoch ER. Posterior versus lateral surgical approach for total hip arthroplasty in adults with osteoarthritis. Cochrane Database Syst Rev. 2004;(1):CD003828. doi: 10.1002/14651858.CD003828.pub2.
PubMed 14974039Krotenberg R, Stitik T, Johnston MV. Incidence of dislocation following hip arthroplasty for patients in the rehabilitation setting. Am J Phys Med Rehabil. 1995 Nov-Dec;74(6):444-7. doi: 10.1097/00002060-199511000-00010.
PubMed 8534389Masaoka T, Yamamoto K, Shishido T, Katori Y, Mizoue T, Shirasu H, Nunoda D. Study of hip joint dislocation after total hip arthroplasty. Int Orthop. 2006 Feb;30(1):26-30. doi: 10.1007/s00264-005-0032-4. Epub 2005 Dec 13.
PubMed 16344996Barnsley L, Barnsley L, Page R. Are Hip Precautions Necessary Post Total Hip Arthroplasty? A Systematic Review. Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):230-5. doi: 10.1177/2151458515584640.
PubMed 26328242
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of the Impact on Function of an Unrestricted Rehabilitation Pathway of no Precautions Following Total Hip Replacement
- ClinicalTrials.gov ID
- NCT03833258
- Acronym / sponsor ID
- ReHip2 / NHS001514
- Conditions
- Total Hip Replacement
- Keywords
- THR, THA, Total Hip Arthroplasty, Total Hip Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID 19 resulted in cancellation of all elective surgery therefore we need to terminate the trial with 95 participants.
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 6 Feb 2019 (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.
The purpose of ReHip2 is to explore the impact on function and quality of life in patients following Total Hip Replacement (THR). A randomised controlled trial will compare two different rehabilitation pathways following surgery (Routine care with precautions and Treatment group with no precautions). The proposal is to carry out the RCT with a minimum of 182 patients based in the UK.
Detailed description
Dislocation of the hip following total hip replacement (THR) is the sole reason for the endorsement of precautions following THR. This has remained unchanged sine the first hip replacement in 1969.
The precautions are;
- Patients must not bend past 90 degrees at the hip (including sitting)
- Patients must not twist in either standing or sitting
- Patients must partial weight bear with elbow crutches for a minimum of 6 weeks
- Patients must sleep on their back for a minimum of 6 weeks
- Patients must not cross their legs
Studies exploring factors affecting dislocation following THR identified three main influences: surgical technique, type of prosthesis and post-operative precautions. A number of studies have challenged the continued use of precautions or explored their impact on dislocation. However, these studies did not fully consider the impact of all precautions on dislocation, choosing to only select elements of the precautions for investigation. A recent review concluded the evidence evaluating practice and the impact of precautions was of poor quality. The review suggested further research should take into account different surgical approaches, different femoral head sizes and the type of prosthesis. Although there are studies that explored some of these hip dislocation confounders, the true impact of precautions remains unknown.
Whilst precautions continue to be endorsed by surgeons and other clinicians, previous challenges have raised awareness of the possible excessiveness of precautions and the importance of further robust work recommended. This is particularly so in the wake of developments in surgical technique and prostheses design, such as hip joint capsule repair and larger femoral head sizes (larger hip replacements). These developments and their impact on dislocation are beginning to cast doubt on the impact of post-operative precautions and their direct link to incidence of dislocation, which is their primary purpose.
The imposition of precautions has been evidenced to impact on both function and quality of life, with resultant non adherence in a proportion of patients. This study intends to explore whether an unrestricted pathway has no worse outcome in function, pain and quality of life parameters, in two specialist units in a multi-centre, prospective, randomised, non-inferiority study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation with precautions | No intervention | –Patients in this arm will continue with rehabilitation following routine care recommendations after total hip replacement; therefore following precautions. |
| Rehabilitation with no precautions | Experimental | Behavioral: Rehabilitation with no precautionsPatients in this arm will continue with rehabilitation after total hip replacement without precautions, being permitted to move within limits of their own pain only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult participants over the age of 18 years will be included.
- All participants should be proceeding with routine care unilateral (one side only) primary THR for treatment of osteoarthritis
- The patients operating consultant agreed to involvement of their patients in the study.
- All subjects assessed during routine pre-operative assessment in their respective hospital will have been assigned an American Society of Anesthesiologists (ASA) up to grade 3 out of a total of 6 (defined as 'severe systemic disease that limits activity but is not incapacitating').
- Patients who have undergone previous hip injection for treatment of osteoarthritic symptoms.
Key exclusion criteria (8 listed)
- The operating consultant declined participation in the study.
- The participant previously had hip surgery to the same hip, including arthroscopy, revision hip surgery or treatment for Avascular Necrosis.
- ASA grade 4 or above 'A patient with severe systemic disease that is a constant threat to life.'
- Patients with specifically identified increased risk of dislocation (for example neuromuscular disease, hypermobility)
- Complex primary hip replacement (THR with femoral osteotomy or structural bone grafting / augmentation of acetabulum)
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 |
|---|---|---|
| Rehabilitation with no precautionsPatients will recover from total hip replacement surgery being guided by pain only and not by the precautions imposed upon them by clinicians. | Behavioural | Rehabilitation with no precautions |
Primary outcome
Oxford Hip Score (OHS)
Time frame: assessed at baseline, 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
Consists of 12 items measuring pain, activity, joint mobility and ambulatory activity using a 5 point ordinal Likert Scale over the previous 4 weeks. The total score for the OHS range from 12-60 with the lowest score of 12 signifying the least limited function and the highest score of 60 signifying the most limited function.
2 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
EQ-5D-L
Time frame: assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
Results and safety
The study was stopped early (reason given: COVID 19 resulted in cancellation of all elective surgery therefore we need to terminate the trial with 95 participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Background: PubMed 18828962Blom AW, Rogers M, Taylor AH, Pattison G, Whitehouse S, Bannister GC. Dislocation following total hip replacement: the Avon Orthopaedic Centre experience. Ann R Coll Surg Engl. 2008 Nov;90(8):658-62. doi: 10.1308/003588408X318156. Epub 2008 Sep 30.
- Background: PubMed 16264121Berry DJ, von Knoch M, Schleck CD, Harmsen WS. Effect of femoral head diameter and operative approach on risk of dislocation after primary total hip arthroplasty. J Bone Joint Surg Am. 2005 Nov;87(11):2456-63. doi: 10.2106/JBJS.D.02860.
- Background: PubMed 14711939Berry DJ, von Knoch M, Schleck CD, Harmsen WS. The cumulative long-term risk of dislocation after primary Charnley total hip arthroplasty. J Bone Joint Surg Am. 2004 Jan;86(1):9-14. doi: 10.2106/00004623-200401000-00003.
- Background: PubMed 5459811Charnley J. Total hip replacement by low-friction arthroplasty. Clin Orthop Relat Res. 1970 Sep-Oct;72:7-21. No abstract available.
- Background: PubMed 27374001Smith TO, Jepson P, Beswick A, Sands G, Drummond A, Davis ET, Sackley CM. Assistive devices, hip precautions, environmental modifications and training to prevent dislocation and improve function after hip arthroplasty. Cochrane Database Syst Rev. 2016 Jul 4;7(7):CD010815. doi: 10.1002/14651858.CD010815.pub2.
- Background: PubMed 19968217Ververeli PA, Lebby EB, Tyler C, Fouad C. Evaluation of reducing postoperative hip precautions in total hip replacement: a randomized prospective study. Orthopedics. 2009 Dec;32(12):889. doi: 10.3928/01477447-20091020-09.
- Background: PubMed 21076896Restrepo C, Mortazavi SM, Brothers J, Parvizi J, Rothman RH. Hip dislocation: are hip precautions necessary in anterior approaches? Clin Orthop Relat Res. 2011 Feb;469(2):417-22. doi: 10.1007/s11999-010-1668-y.
- Background: PubMed 15469226Soong M, Rubash HE, Macaulay W. Dislocation after total hip arthroplasty. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):314-21. doi: 10.5435/00124635-200409000-00006.
- Background: PubMed 19277807Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009 Jun;467(6):1400-11. doi: 10.1007/s11999-009-0750-9. Epub 2009 Mar 10.
- Background: PubMed 24476806Mikkelsen LR, Petersen MK, Soballe K, Mikkelsen S, Mechlenburg I. Does reduced movement restrictions and use of assistive devices affect rehabilitation outcome after total hip replacement? A non-randomized, controlled study. Eur J Phys Rehabil Med. 2014 Aug;50(4):383-93. Epub 2014 Jan 30.
- Background: PubMed 17197308Duwelius PJ, Burkhart RL, Hayhurst JO, Moller H, Butler JB. Comparison of the 2-incision and mini-incision posterior total hip arthroplasty technique: a retrospective match-pair controlled study. J Arthroplasty. 2007 Jan;22(1):48-56. doi: 10.1016/j.arth.2006.09.012.
- Background: PubMed 14974039Jolles BM, Bogoch ER. Posterior versus lateral surgical approach for total hip arthroplasty in adults with osteoarthritis. Cochrane Database Syst Rev. 2004;(1):CD003828. doi: 10.1002/14651858.CD003828.pub2.
- 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.
JACQUELINE OLDHAM study chair
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation with no precautions in people with Total Hip Replacement, run by University of Manchester at 2 sites in United Kingdom.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID 19 resulted in cancellation of all elective surgery therefore we need to terminate the trial with 95 participants.). Results are not available in the source record.
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?
Oxford Hip Score (OHS) (time frame: assessed at baseline, 6 and 12 weeks after total hip replacement to assess change at each time point following surgery). 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 NCT03833258, which also lists 33 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 Nov 2022.