Hip OsteoarthritisHIPPERNCT02969512
Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER)
A study testing HIPPER and OASIS Online Educational Webinars in people with Hip Osteoarthritis, run by University of British Columbia at 1 site in Canada.
Trial summary
Osteoarthritis (OA), leading to hip replacement, is a leading contributor to global mobility impairment. Given the boom in the older demographic it is not surprising that there is an 11% increased demand for replacement every 5 years in Canada. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- HIPPER and OASIS Online Educational Webinars
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2021to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling participants with advanced hip OA will be included if they:
- are living in the greater Vancouver region;
- are aged 50 years or older;
- are scheduled to have a single THR in 12 weeks or later;
- have access to the internet
Who cannot join
- cannot communicate and complete questionnaires in English;
- anticipate a health condition or procedure that contraindicates their THR surgery;
- are actively receiving physical therapy for their hip symptoms;
- have had a previous THR.
Trial locations and contacts
1 site in 1 country.
Canada1 site
GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) Intervention Protocol: An eHealth Approach for Pre-surgical Hip Replacement Education
Osteoarthritis (OA), leading to hip replacement, is a leading contributor to global mobility impairment. Given the boom in the older demographic it is not surprising that there is an 11% increased demand for replacement every 5 years in Canada. Health promotion interventions, such as prehabilitation, defined as pre-surgical education, are vital to optimizing surgical outcomes, reducing hospitalization costs, accelerating rehabilitation, and reducing patient discomfort and pre-operative anxiety. HIPPER is a 2-year randomized controlled trial (RCT) that will assess feasibility indicators and clinical outcomes of online prehab education modules compared to online educational webinars. The feasibility indicators (process, resource, management, and treatment issues) and clinical outcomes (physical function, anxiety, depression, pain, daily activities, self-efficacy, and health related quality of life) will be assessed among Vancouver-dwelling older adults aged > 50 years, with advanced hip osteoarthritis. The findings will lead to the refinement of the design protocol in order to evaluate a contemporary, standardized, and geographically accessible prehab education program in a large multi-site RCT.
Read the detailed description
This feasibility study will use a single-site, parallel group evaluator blind RCT. Subjects (N=40) will be randomly assigned to the experimental (HIPPER n=20) or control (n=20) groups.The experimental group will receive the interactive online HIPPER intervention consisting of 12 modules (~20 mins/module). The control group is usual practice consisting of a 2 hr online large group educational webinar. Feasibility indicators (i.e. recruitment and retention; subject burden; safety; intervention administration/adherence; perceived benefit) will be evaluated as binary outcomes against pre-set parameters reflecting viability for a multi-site large-scale RCT. The primary clinical outcome of interest when assessing effect size for the eventual RCT is the Hospital Anxiety and Depression Scale-Anxiety. Secondary clinical outcomes include measures of pain, function, daily activities, self-efficacy, equipment checklist, system usability scale, environmental setup, physical activity, and health related quality of life.
Upon successful screening/enrollment and baseline data collection (T1) the Study Coordinator will contact the statistician by telephone or email and obtain group assignment within 48 hours. Subjects will be randomized using a 1:1 allocation ratio between groups. A central computerized randomization process will be designed by the statistician, with an undisclosed block size. To address bias, subjects will be instructed not to discuss their program and Testers will reinforce this point at each session. T1 data will be collected at our clinic while the follow up data collected 7-10 days prior to surgery (T2), and 30 days post-surgery (T3).
The findings from the study will be summarized and mailed to each participant upon study completion. HIPPER and control group assessments will be held at GF Strong Rehabilitation Centre and at subject's homes.
The outcome will lead to the refinement of the design protocol in order to robustly evaluate a contemporary, standardized, and geographically accessible prehabilitation education program. Ultimately, HIPPER may be found to have significant individual and social (health system level) benefits.
- Conditions
- Hip Osteoarthritis
- Being tested
- HIPPER, OASIS Online Educational Webinars
- Keywords
- Patient education, Advanced hip osteoarthritis, Online education, Computer-assisted instruction, e-learning, Older adult
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPPEROther
Also called Behavioral: Online prehab education
Participants can complete the online educational modules at home or another location with internet access. The total time to complete all of the modules is about 2 hours and 30 minutes.
OASIS Online Educational WebinarsOther
Also called Behavioral: large group education sessions
2-hour online educational large group sessions
| Study group | Role | What they receive |
|---|---|---|
| HIPPER | Experimental | The HIPPER group will receive 12 interactive online modules (~20 minutes each). HIPPER participants will receive email or phone contact (participant preference) to provide them with website portal access consisting of the web address, and simple instructions to access the website using personalized encrypted login information to the site. Receives: Other: HIPPER |
| OASIS Online Educational Webinars | Active comparator | To provide a comparable level of education, participants in the Online Education group will receive 2 hours of OASIS online educational webinars as per current practice. Receives: Other: OASIS Online Educational Webinars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
The Hospital Anxiety and Depression Scale (HADS-A) measures anxiety symptoms. The anxiety subscale (HADS-A) has 7 items, each rated 0-3 and summed to a total of 0-21. Higher scores indicate worse outcomes (greater anxiety).
Measured: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
Secondary outcomes (9)
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
The Hospital Anxiety and Depression Scale (HADS-D) measures depression symptoms. The depression subscale (HADS-D) has 7 items, each rated 0-3 and summed to a total of 0-21. Higher scores indicate higher levels of depression.
Measured: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
Oxford Hip Score (OHS)
The Oxford Hip Score (OHS) measures pain and function in patients with hip osteoarthritis. It has 12 items, each rated 0-4, summed to a total of 0-48. Higher scores indicate lower levels of disability.
Measured: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
Change in Self-Efficacy for Rehabilitation Outcome Scale (SER)
The Self-Efficacy for Rehabilitation Outcome Scale (SER) measures confidence in performing rehabilitation activities. It has 12 items, each rated 0-10, summed to a total of 0-120. Higher scores indicate greater self-efficacy.
Measured: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
System Usability Scale (SUS)
The System Usability Scale (SUS) measures perceived usability of a system. It has 10 items rated on a 5-point scale; item scores are converted, summed, and multiplied by 2.5 to give a total of 0-100. Higher scores indicate better perceived usability.
Measured: T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery); Completed only by participants in the HIPPER group.
Hip Disability and Osteoarthritis Outcome Score - Activities of Daily Living Subscale (HOOS-ADL)
The Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities of Daily Living (ADL) subscale measures difficulty with daily activities in patients with hip osteoarthritis. It has 17 items, each rated on a five-point Likert scale (0 = none to 4 = extreme difficulty), summed to a total ranging from 0 to 68. Higher scores indicate greater difficulty with daily activities.
Measured: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
Physical Activity Scale for the Elderly (PASE)
The Physical Activity Scale for the Elderly (PASE) measures self-reported physical activity over the past 7 days in older adults. Scores are a weighted sum of time spent across activity types, ranging from 0 to 400 or more. Higher scores indicate greater physical activity.
Measured: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses were converted to a single utility index ranging from -0.285 to 1 (extreme problems on all dimensions) to 1 (full health). Higher scores indicate better health-related quality of life.
Measured: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
Equipment Checklist
The Equipment Checklist included recommended equipment and mobility aids for total hip replacement. This checklist was developed in accordance with current guidelines and clinical recommendations. Participants indicated which items they had obtained. The reported value is the number of items obtained per participant. Higher scores indicate more recommended equipment obtained.
Measured: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
30-second Chair-Stand Test
The 30-Second Chair-Stand Test measures lower-body strength and endurance. Participants stand fully from a seated position and sit back down as many times as possible within 30 seconds. The score is the number of completed sit-to-stand repetitions. Higher scores indicate better lower-body strength and function.
Measured: T1 (Baseline); T2 (7-10 days before surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start10 Jan 2021
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, William C. Miller, University of British Columbia
- Investigators
- William C Miller, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969512
- Sponsor's protocol ID
- H16-02553
- Acronym
- HIPPER
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2016
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simpson, E., Mohammadi, S., Miller, W. C., Yu, N., Watson, W., Spillane, A., & Westby, M. D. (2022). Reliability of conducting the 30-second chair stand test virtually among individuals with osteoarthritis. Archives of Rheumatology & Arthritis Research, 2(4), Article ARAR.MS.ID.000542.
Dhariwal A, Mohammadi S, Simpson E, Westby MD, Watson W, Miller WC. Patient-centered perspectives: A qualitative evaluation of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER). PLoS One. 2025 Apr 24;20(4):e0322114. doi: 10.1371/journal.pone.0322114. eCollection 2025.
PubMed 40273090Miller WC, Mohammadi S, Watson W, Crocker M, Westby M. The Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) as an eHealth Approach to Presurgical Hip Replacement Education: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 6;10(7):e29322. doi: 10.2196/29322.
PubMed 34255722Mohammadi S, Westby MD, Schneeberg A, Watson W, Dhariwal A, Simpson E, Miller WC. The hip instructional prehabilitation program for enhanced recovery (HIPPER) as an eHealth approach to presurgical hip replacement Education: Feasibility randomized controlled trial. Int J Orthop Trauma Nurs. 2025 Aug;58:101210. doi: 10.1016/j.ijotn.2025.101210. Epub 2025 Jun 18.
PubMed 40580786
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) Intervention Protocol: An eHealth Approach for Pre-surgical Hip Replacement Education
- ClinicalTrials.gov ID
- NCT02969512
- Acronym / sponsor ID
- HIPPER / H16-02553
- Conditions
- Hip Osteoarthritis
- Keywords
- Patient education, Advanced hip osteoarthritis, Online education, Computer-assisted instruction, e-learning, Older adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Posted 17 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA), leading to hip replacement, is a leading contributor to global mobility impairment. Given the boom in the older demographic it is not surprising that there is an 11% increased demand for replacement every 5 years in Canada. Health promotion interventions, such as prehabilitation, defined as pre-surgical education, are vital to optimizing surgical outcomes, reducing hospitalization costs, accelerating rehabilitation, and reducing patient discomfort and pre-operative anxiety. HIPPER is a 2-year randomized controlled trial (RCT) that will assess feasibility indicators and clinical outcomes of online prehab education modules compared to online educational webinars. The feasibility indicators (process, resource, management, and treatment issues) and clinical outcomes (physical function, anxiety, depression, pain, daily activities, self-efficacy, and health related quality of life) will be assessed among Vancouver-dwelling older adults aged > 50 years, with advanced hip osteoarthritis. The findings will lead to the refinement of the design protocol in order to evaluate a contemporary, standardized, and geographically accessible prehab education program in a large multi-site RCT.
Detailed description
This feasibility study will use a single-site, parallel group evaluator blind RCT. Subjects (N=40) will be randomly assigned to the experimental (HIPPER n=20) or control (n=20) groups.The experimental group will receive the interactive online HIPPER intervention consisting of 12 modules (~20 mins/module). The control group is usual practice consisting of a 2 hr online large group educational webinar. Feasibility indicators (i.e. recruitment and retention; subject burden; safety; intervention administration/adherence; perceived benefit) will be evaluated as binary outcomes against pre-set parameters reflecting viability for a multi-site large-scale RCT. The primary clinical outcome of interest when assessing effect size for the eventual RCT is the Hospital Anxiety and Depression Scale-Anxiety. Secondary clinical outcomes include measures of pain, function, daily activities, self-efficacy, equipment checklist, system usability scale, environmental setup, physical activity, and health related quality of life.
Upon successful screening/enrollment and baseline data collection (T1) the Study Coordinator will contact the statistician by telephone or email and obtain group assignment within 48 hours. Subjects will be randomized using a 1:1 allocation ratio between groups. A central computerized randomization process will be designed by the statistician, with an undisclosed block size. To address bias, subjects will be instructed not to discuss their program and Testers will reinforce this point at each session. T1 data will be collected at our clinic while the follow up data collected 7-10 days prior to surgery (T2), and 30 days post-surgery (T3).
The findings from the study will be summarized and mailed to each participant upon study completion. HIPPER and control group assessments will be held at GF Strong Rehabilitation Centre and at subject's homes.
The outcome will lead to the refinement of the design protocol in order to robustly evaluate a contemporary, standardized, and geographically accessible prehabilitation education program. Ultimately, HIPPER may be found to have significant individual and social (health system level) benefits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIPPER | Experimental | Other: HIPPERThe HIPPER group will receive 12 interactive online modules (~20 minutes each). HIPPER participants will receive email or phone contact (participant preference) to provide them with website portal access consisting of the web address, and simple instructions to access the website using personalized encrypted login information to the site. |
| OASIS Online Educational Webinars | Active comparator | Other: OASIS Online Educational WebinarsTo provide a comparable level of education, participants in the Online Education group will receive 2 hours of OASIS online educational webinars as per current practice. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are living in the greater Vancouver region;
- are aged 50 years or older;
- are scheduled to have a single THR in 12 weeks or later;
- have access to the internet
Key exclusion criteria (4 listed)
- cannot communicate and complete questionnaires in English;
- anticipate a health condition or procedure that contraindicates their THR surgery;
- are actively receiving physical therapy for their hip symptoms;
- have had a previous THR.
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 |
|---|---|---|
| HIPPERAlso: Behavioral: Online prehab educationParticipants can complete the online educational modules at home or another location with internet access. The total time to complete all of the modules is about 2 hours and 30 minutes. | Other | HIPPER |
| OASIS Online Educational WebinarsAlso: Behavioral: large group education sessions2-hour online educational large group sessions | Other | OASIS Online Educational Webinars |
Primary outcome
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
The Hospital Anxiety and Depression Scale (HADS-A) measures anxiety symptoms. The anxiety subscale (HADS-A) has 7 items, each rated 0-3 and summed to a total of 0-21. Higher scores indicate worse outcomes (greater anxiety).
9 secondary outcomes
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Time frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
Oxford Hip Score (OHS)
Time frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
Change in Self-Efficacy for Rehabilitation Outcome Scale (SER)
Time frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
System Usability Scale (SUS)
Time frame: T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery); Completed only by participants in the HIPPER group.
Hip Disability and Osteoarthritis Outcome Score - Activities of Daily Living Subscale (HOOS-ADL)
Time frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
Physical Activity Scale for the Elderly (PASE)
Time frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score
Time frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
Equipment Checklist
Time frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
30-second Chair-Stand Test
Time frame: T1 (Baseline); T2 (7-10 days before surgery).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationSimpson, E., Mohammadi, S., Miller, W. C., Yu, N., Watson, W., Spillane, A., & Westby, M. D. (2022). Reliability of conducting the 30-second chair stand test virtually among individuals with osteoarthritis. Archives of Rheumatology & Arthritis Research, 2(4), Article ARAR.MS.ID.000542.
- Results publication: PubMed 40273090Dhariwal A, Mohammadi S, Simpson E, Westby MD, Watson W, Miller WC. Patient-centered perspectives: A qualitative evaluation of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER). PLoS One. 2025 Apr 24;20(4):e0322114. doi: 10.1371/journal.pone.0322114. eCollection 2025.
- Results publication: PubMed 34255722Miller WC, Mohammadi S, Watson W, Crocker M, Westby M. The Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) as an eHealth Approach to Presurgical Hip Replacement Education: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 6;10(7):e29322. doi: 10.2196/29322.
- Results publication: PubMed 40580786Mohammadi S, Westby MD, Schneeberg A, Watson W, Dhariwal A, Simpson E, Miller WC. The hip instructional prehabilitation program for enhanced recovery (HIPPER) as an eHealth approach to presurgical hip replacement Education: Feasibility randomized controlled trial. Int J Orthop Trauma Nurs. 2025 Aug;58:101210. doi: 10.1016/j.ijotn.2025.101210. Epub 2025 Jun 18.
- Individual participant dataSharing planned: No
Related trials for Hip Osteoarthritis
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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.
William C Miller, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIPPER and OASIS Online Educational Webinars in people with Hip Osteoarthritis, run by University of British Columbia at 1 site in Canada.
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 5 inclusion and 4 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 17 Aug 2026. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) (time frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after 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 NCT02969512, which also lists 4 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 17 Aug 2026.