OsteoartritERASNCT06980857
The Effect of the Physiotherapy Program Added to the ERAS Protocol in Patients With Total Knee Arthroplasty
A study testing ERAS Group and Multimodal physiotherapy group combined with ERAS protocol in people with Osteoartrit and ERAS protokolü, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the effects of bilateral total knee arthroplasty in patients with primary gonarthrosis ERAS protocol compared to standard rehabilitation protocol in the perioperative period to evaluate patients' pain, functional status and satisfaction. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Osteoartrit, ERAS protokolü, Total Diz Artroplastisi
- What is being tested?
- ERAS Group and Multimodal physiotherapy group combined with ERAS protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 60-80,
- Diagnosed with primary gonarthrosis,
- Individuals who decided to undergo total knee arthroplasty were included in the study.
Who cannot join
- Those with any neurological disease,
- Received physical therapy in the last 3 months,
- Those with cardiac problems (pacemarker),
- Those with systemic disease,
- Individuals who had revision surgery were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effect of the Physiotherapy Program Added to the ERAS Protocol on Pain, Function and Patient Satisfaction in Patients With Total Knee Arthroplasty
The aim of the study was to investigate the effects of bilateral total knee arthroplasty in patients with primary gonarthrosis ERAS protocol compared to standard rehabilitation protocol in the perioperative period to evaluate patients' pain, functional status and satisfaction. The main questions it aims to answer are:
- Physiotherapy applications added to the ERAS protocol after total knee arthroplasty are not effective on pain, function and patient satisfaction.
- Physiotherapy applications added to the ERAS protocol after total knee arthroplasty are effective on pain, function and patient satisfaction.
The investigators will be divided and allocated into 3 groups. Group 1 received standard treatment after TKA program will be applied, Group 2 will receive treatment with the ERAS protocol, and Group 3 will add a multimodal physiotherapy program to the ERAS protocol.
Read the detailed description
After total knee arthroplasty (TKA), the patient must receive physical therapy to regain muscle strength, independent movement, and return to activities of daily living (ADL). One of the groups most frequently treated for rehabilitation during post-surgical hospitalization is patients who have undergone total knee arthroplasty surgery. Studies show that post-surgical patients return to their normal daily lives within approximately 6 weeks.However, complications, infections, limitation of the knee joint, additional post-surgical disorders, circulatory problems, vascular nerve problems, pain, rheumatic diseases affect the success of the surgery and the patient's recovery process.
Enhanced Postoperative Recovery Protocols (ERAS) are defined as a multidisciplinary approach that uses a combination of evidence-based practices to improve patient care. The treatment methods included in ERAS protocols are based on the understanding that the healing process can be optimized by protecting patients from catabolism and immune system disorders with factors such as pain management, regulation of fluid therapy, early mobilization and improvement of nutrition.This protocol includes a surgeon, anesthesiologist, nurse, dietitian and physiotherapist. The ERAS protocol considers the patient who will undergo surgery in 3 periods: preoperative period, intraoperative period and postoperative period. Starting with informing the patient before the surgery, bowel preparation, fasting period, alcohol and smoking cessation period, pre-surgical exercise training, surgical method, use of drains or tubes, type of anesthesia, post-surgical fluid intake, switching to carbohydrates, use of analgesia, early removal of tubes and drains. It covers principles such as removal and early mobilization. Looking at the results of research conducted by different disciplines, it is seen that the hospitalization period of patients applied to the ERAS protocol is shortened, their readmissions are reduced and complications are prevented.
Physiotherapy has a very small place in this multidisciplinary team. While it is mentioned that early mobilization plays a key role, it is not emphasized that exercise will accelerate mobilization, increase muscle strength and reduce pain.
Since the place of physiotherapy in the ERAS studies examined in the literature is limited and not comprehensive, the aim of this study is to evaluate the pain, function and patient satisfaction of the pre-op patient education, pain education, exercise, quadriceps muscle stimulation, post-op physiotherapy program applied in addition to the ERAS protocol in patients undergoing total knee arthroplasty. To investigate its effect on
- Conditions
- Osteoartrit, ERAS protokolü, Total Diz Artroplastisi
- Being tested
- Control Group, ERAS Group, Multimodal physiotherapy group combined with ERAS protocol
- Keywords
- ERAS protokolü, Total diz artroplastisi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
In our study, this group will be placed in hyperextension position and immobilized on postoperative day 0. Postop 1-2. Foot pumping exercises, isometric quadriceps exercises, passive knee extension, straight leg raising, 0-40 degree passive knee flexion, partial/full weight ambulation, respiratory exercises and cold application will be performed daily. On postoperative days 3-6 (depending on discharge time), stretching in passive knee extension, active/assisted quadriceps exercises, isometric-isotonic exercise for leg and hip muscles, 90-0 knee extension, 0-90 degree passive knee flexion exercises will be performed.
ERAS GroupOther
In our study, this group of patients were informed about the surgical procedure to be performed by the orthopedist; detailed information about the postoperative rehabilitation process, prevention of possible complications, preoperative nutrition, smoking and alcohol cessation time will be given. The patient will stop eating solid food 6 hours before the operation and stop drinking fluids 2 hours before the operation. Necessary consultations will be completed before surgery. Preoperative preparation of the patient will be organized according to the ERAS protocol. The patient will be mobilized early, either in bed or in the room, within 6-7 hours after surgery. The exercises of the first group will be continued from the first postoperative day.
Multimodal physiotherapy group combined with ERAS protocolOther
In our study, this group of patients who were informed about the surgery by the orthopedist will be examined by the anesthesiologist 1 week before surgery. Patients whose anesthesia preparation is completed will participate in a training program about pain, prevention of postoperative complications, auxiliary devices/equipment and exercises to be used, accompanied by a physiotherapist and a nurse. At the end of the program, patients will be given a 1-week home exercise program prepared by the physiotherapist. NMES device will be connected to the quadriceps muscles for 20 minutes half an hour before surgery, immediately after surgery and every day during hospitalization. Postoperatively, the patient will be mobilized early within 6-7 hours and the knee will be placed in hyperextension position. From the 1st day onwards, the exercises of the first group will be continued.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Lower extremity exercises Receives: Other: Control Group |
| Eras Group | Active comparator | Lower extremity exercises and early mobilization Receives: Other: ERAS Group |
| Multimodal physiotherapy group combined with ERAS protocol | Experimental | Preoperative pain education and home exercise brochure, early postoperative mobilization, lower extremity exercises, NMES current connection to quadriceps muscles in preop and postop process Receives: Other: Multimodal physiotherapy group combined with ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
A visual analog scale will be used to measure pain intensity and to monitor pain. This scale is a simple way to measure the intensity of pain. On a 10 cm horizontal scale, '0' means no pain and '10' means the most severe pain. A higher score indicates a worse outcome.
Measured: 15 days
Oxford Knee Score
It will be used to assess physical function and pain. The Oxford Knee Score (OKS) developed by Dawson et al. is a 12-question reliable and validated questionnaire designed to assess pain and physical function based on the last 4 weeks in patients undergoing total knee arthroplasty. For each question, there are 5 response categories graded from 0 (worst) to 4 (best) points. Scores between 0-19 indicate severe knee arthritis, scores between 20-29 indicate moderate joint function, scores between 30-39 indicate mild joint function and scores between 40-48 indicate normal joint function. Items include pain, movement, limitation, standing up from a sitting position, squatting, walking up and down stairs, sleeping, housework, shopping, personal needs and transportation.
Measured: 15 days
Hospital for Special Surgery
It will be used to assess pain, function, range of motion, muscle strength, deformity and instability in patients with total knee arthroplasty. It includes both objective and subjective assessment. The evaluation is based on 100 points. A score of 85 and above is considered excellent, 70-84 is considered good, 60-69 is considered fair and 60 and below is considered poor. A high score means that the results are good.
Measured: 15 days
Timed Up and Go Test
It is done to measure the risk of falling and balance. The test requires a chair, a stopwatch and a 3-meter space. It is an easy test to perform with minimal equipment. The test measures the time between standing up from a sitting chair, walking 3 meters forward at normal speed, turning, walking 3 meters again, and sitting back in the chair. If a person completes this test in more than 12 seconds, they are at risk of falling. A longer duration means a poor outcome
Measured: 15 days
Stair Climbing Test
A stair climbing test will be performed to assess lower limb strength, stair climbing ability and balance. Participants were asked to climb 9 steps with step intervals between 16-20 cm and the interval was recorded in seconds. A longer time means a poor result.
Measured: 15 days
Assessment of Normal Range of Joint Motion
Normal range of motion and knee flexion-extension values will be assessed using a universal goniometer. During the measurement, the pivot point was taken as the lateral condyle of the femur and the fixed arm was placed parallel to the lateral midline of the femur. The mobile arm was positioned to follow the fibula. Goniometry is a simple instrument, easy to use and carry. It offers objective evaluation. In addition to assessing NEH, it is also used to determine a treatment program and to determine functional capacity.
Measured: 15 days
Notthingam Health Profile
The Nottingham Health Profile will be used in our quality of life assessment. In the questionnaire consisting of 38 items, 6 different parameters related to health status are evaluated. These parameters are physical activity (8 items), emotional reactions (9 items), energy (3 items), social isolation (5 items), pain (8 items), and sleep (5 items). Each subparameter is scored between 0-100. A high score indicates worsening health. The total score is obtained by summing all sub-parameter scores.
Measured: 15 days
Patient Satisfaction Survey
Participants' satisfaction will be evaluated with this scale After total knee arthroplasty (TKA), participants were asked whether they were satisfied with the surgical procedure. Patients were asked to rate their level of satisfaction on a scale of 1 to 5. Responses ranged from 1 - not at all satisfied to 5 - very satisfied. A high score means a high level of satisfaction. Participants' responses were recorded on a 5-point Likert scale.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start2 Jan 2025
- Primary completion25 Aug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoartritStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gül D Yılmaz Yelvar, Prof, Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980857
- Sponsor's protocol ID
- 3/2022.K-86
- Acronym
- ERAS
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of the Physiotherapy Program Added to the ERAS Protocol on Pain, Function and Patient Satisfaction in Patients With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06980857
- Acronym / sponsor ID
- ERAS / 3/2022.K-86
- Conditions
- Osteoartrit, ERAS protokolü, Total Diz Artroplastisi
- Keywords
- ERAS protokolü, Total diz artroplastisi
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 May 2025 (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 aim of the study was to investigate the effects of bilateral total knee arthroplasty in patients with primary gonarthrosis ERAS protocol compared to standard rehabilitation protocol in the perioperative period to evaluate patients' pain, functional status and satisfaction. The main questions it aims to answer are:
- Physiotherapy applications added to the ERAS protocol after total knee arthroplasty are not effective on pain, function and patient satisfaction.
- Physiotherapy applications added to the ERAS protocol after total knee arthroplasty are effective on pain, function and patient satisfaction.
The investigators will be divided and allocated into 3 groups. Group 1 received standard treatment after TKA program will be applied, Group 2 will receive treatment with the ERAS protocol, and Group 3 will add a multimodal physiotherapy program to the ERAS protocol.
Detailed description
After total knee arthroplasty (TKA), the patient must receive physical therapy to regain muscle strength, independent movement, and return to activities of daily living (ADL). One of the groups most frequently treated for rehabilitation during post-surgical hospitalization is patients who have undergone total knee arthroplasty surgery. Studies show that post-surgical patients return to their normal daily lives within approximately 6 weeks.However, complications, infections, limitation of the knee joint, additional post-surgical disorders, circulatory problems, vascular nerve problems, pain, rheumatic diseases affect the success of the surgery and the patient's recovery process.
Enhanced Postoperative Recovery Protocols (ERAS) are defined as a multidisciplinary approach that uses a combination of evidence-based practices to improve patient care. The treatment methods included in ERAS protocols are based on the understanding that the healing process can be optimized by protecting patients from catabolism and immune system disorders with factors such as pain management, regulation of fluid therapy, early mobilization and improvement of nutrition.This protocol includes a surgeon, anesthesiologist, nurse, dietitian and physiotherapist. The ERAS protocol considers the patient who will undergo surgery in 3 periods: preoperative period, intraoperative period and postoperative period. Starting with informing the patient before the surgery, bowel preparation, fasting period, alcohol and smoking cessation period, pre-surgical exercise training, surgical method, use of drains or tubes, type of anesthesia, post-surgical fluid intake, switching to carbohydrates, use of analgesia, early removal of tubes and drains. It covers principles such as removal and early mobilization. Looking at the results of research conducted by different disciplines, it is seen that the hospitalization period of patients applied to the ERAS protocol is shortened, their readmissions are reduced and complications are prevented.
Physiotherapy has a very small place in this multidisciplinary team. While it is mentioned that early mobilization plays a key role, it is not emphasized that exercise will accelerate mobilization, increase muscle strength and reduce pain.
Since the place of physiotherapy in the ERAS studies examined in the literature is limited and not comprehensive, the aim of this study is to evaluate the pain, function and patient satisfaction of the pre-op patient education, pain education, exercise, quadriceps muscle stimulation, post-op physiotherapy program applied in addition to the ERAS protocol in patients undergoing total knee arthroplasty. To investigate its effect on
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Control GroupLower extremity exercises |
| Eras Group | Active comparator | Other: ERAS GroupLower extremity exercises and early mobilization |
| Multimodal physiotherapy group combined with ERAS protocol | Experimental | Other: Multimodal physiotherapy group combined with ERAS protocolPreoperative pain education and home exercise brochure, early postoperative mobilization, lower extremity exercises, NMES current connection to quadriceps muscles in preop and postop process |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 60-80,
- Diagnosed with primary gonarthrosis,
- Individuals who decided to undergo total knee arthroplasty were included in the study.
Key exclusion criteria (5 listed)
- Those with any neurological disease,
- Received physical therapy in the last 3 months,
- Those with cardiac problems (pacemarker),
- Those with systemic disease,
- Individuals who had revision surgery were not included in the study.
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 |
|---|---|---|
| Control GroupIn our study, this group will be placed in hyperextension position and immobilized on postoperative day 0. Postop 1-2. Foot pumping exercises, isometric quadriceps exercises, passive knee extension, straight leg raising, 0-40 degree passive knee flexion, partial/full weight ambulation, respiratory exercises and cold application will be performed daily. On postoperative days 3-6 (depending on discharge time), stretching in passive knee extension, active/assisted quadriceps exercises, isometric-isotonic exercise for leg and hip muscles, 90-0 knee extension, 0-90 degree passive knee flexion exercises will be performed. | Other | control group |
| ERAS GroupIn our study, this group of patients were informed about the surgical procedure to be performed by the orthopedist; detailed information about the postoperative rehabilitation process, prevention of possible complications, preoperative nutrition, smoking and alcohol cessation time will be given. The patient will stop eating solid food 6 hours before the operation and stop drinking fluids 2 hours before the operation. Necessary consultations will be completed before surgery. Preoperative preparation of the patient will be organized according to the ERAS protocol. The patient will be mobilized early, either in bed or in the room, within 6-7 hours after surgery. The exercises of the first group will be continued from the first postoperative day. | Other | Eras Group |
| Multimodal physiotherapy group combined with ERAS protocolIn our study, this group of patients who were informed about the surgery by the orthopedist will be examined by the anesthesiologist 1 week before surgery. Patients whose anesthesia preparation is completed will participate in a training program about pain, prevention of postoperative complications, auxiliary devices/equipment and exercises to be used, accompanied by a physiotherapist and a nurse. At the end of the program, patients will be given a 1-week home exercise program prepared by the physiotherapist. NMES device will be connected to the quadriceps muscles for 20 minutes half an hour before surgery, immediately after surgery and every day during hospitalization. Postoperatively, the patient will be mobilized early within 6-7 hours and the knee will be placed in hyperextension position. From the 1st day onwards, the exercises of the first group will be continued. | Other | Multimodal physiotherapy group combined with ERAS protocol |
Primary outcome
Visual Analog Scale
Time frame: 15 days
A visual analog scale will be used to measure pain intensity and to monitor pain. This scale is a simple way to measure the intensity of pain. On a 10 cm horizontal scale, '0' means no pain and '10' means the most severe pain. A higher score indicates a worse outcome.
Oxford Knee Score
Time frame: 15 days
It will be used to assess physical function and pain. The Oxford Knee Score (OKS) developed by Dawson et al. is a 12-question reliable and validated questionnaire designed to assess pain and physical function based on the last 4 weeks in patients undergoing total knee arthroplasty. For each question, there are 5 response categories graded from 0 (worst) to 4 (best) points. Scores between 0-19 indicate severe knee arthritis, scores between 20-29 indicate moderate joint function, scores between 30-39 indicate mild joint function and scores between 40-48 indicate normal joint function. Items include pain, movement, limitation, standing up from a sitting position, squatting, walking up and down stairs, sleeping, housework, shopping, personal needs and transportation.
Hospital for Special Surgery
Time frame: 15 days
It will be used to assess pain, function, range of motion, muscle strength, deformity and instability in patients with total knee arthroplasty. It includes both objective and subjective assessment. The evaluation is based on 100 points. A score of 85 and above is considered excellent, 70-84 is considered good, 60-69 is considered fair and 60 and below is considered poor. A high score means that the results are good.
Timed Up and Go Test
Time frame: 15 days
It is done to measure the risk of falling and balance. The test requires a chair, a stopwatch and a 3-meter space. It is an easy test to perform with minimal equipment. The test measures the time between standing up from a sitting chair, walking 3 meters forward at normal speed, turning, walking 3 meters again, and sitting back in the chair. If a person completes this test in more than 12 seconds, they are at risk of falling. A longer duration means a poor outcome
Stair Climbing Test
Time frame: 15 days
A stair climbing test will be performed to assess lower limb strength, stair climbing ability and balance. Participants were asked to climb 9 steps with step intervals between 16-20 cm and the interval was recorded in seconds. A longer time means a poor result.
Assessment of Normal Range of Joint Motion
Time frame: 15 days
Normal range of motion and knee flexion-extension values will be assessed using a universal goniometer. During the measurement, the pivot point was taken as the lateral condyle of the femur and the fixed arm was placed parallel to the lateral midline of the femur. The mobile arm was positioned to follow the fibula. Goniometry is a simple instrument, easy to use and carry. It offers objective evaluation. In addition to assessing NEH, it is also used to determine a treatment program and to determine functional capacity.
Notthingam Health Profile
Time frame: 15 days
The Nottingham Health Profile will be used in our quality of life assessment. In the questionnaire consisting of 38 items, 6 different parameters related to health status are evaluated. These parameters are physical activity (8 items), emotional reactions (9 items), energy (3 items), social isolation (5 items), pain (8 items), and sleep (5 items). Each subparameter is scored between 0-100. A high score indicates worsening health. The total score is obtained by summing all sub-parameter scores.
Patient Satisfaction Survey
Time frame: 15 days
Participants' satisfaction will be evaluated with this scale After total knee arthroplasty (TKA), participants were asked whether they were satisfied with the surgical procedure. Patients were asked to rate their level of satisfaction on a scale of 1 to 5. Responses ranged from 1 - not at all satisfied to 5 - very satisfied. A high score means a high level of satisfaction. Participants' responses were recorded on a 5-point Likert scale.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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.
Gül D Yılmaz Yelvar, Prof principal investigator
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS Group and Multimodal physiotherapy group combined with ERAS protocol in people with Osteoartrit and ERAS protokolü, run by Istinye University at 1 site in Turkey (Türkiye).
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 5 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Scale (time frame: 15 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.