Total Hip ArthroplastyPhase 3(PENG)NCT04591353
Trial Comparing Impact of PENG Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty
A Phase 3 study testing PENG Block and Lidocaine in people with Total Hip Arthroplasty, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
Total hip arthroplasty (THA) is now the second most common joint replacement surgery in the US due in part to an aging population. Opioid sparing analgesic treatments such as lumbar plexus and femoral nerve blocks are effective but they carry a high risk of undesirable lower limb motor or muscle weakness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- PENG Block and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2021to 1 Nov 2022
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing primary total hip arthroplasty
- Patients >=18 years of age
- Patients with an American Society of Anesthesiology (ASA) physical status classification of I, II or III
- Primary THA (first THA operation in the patient's lifetime)
Who cannot join
- Patients with ASA physical status classification 4 or above
- Patients with allergies/intolerances to local anesthetic
- Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the surgical site
- Patients on chronic opioid use or opioid tolerant (The FDA defines a patient as opioid tolerant if for at least 1 week he or she has been receiving oral morphine 60 mg/day; transdermal fentanyl 25 mcg/hour; oral oxycodone 30 mg/day; oral hydromorphone 8 mg/day; oral oxymorphone 25 mg/day; or an equianalgesic dose of any other opioid)
- Poor understanding of English language.
- Patients with coexisting coagulopathy
- Patients that are pharmacologically anticoagulated will be excluded if placement of peripheral nerve block would be contraindicated according to ASRA (American Society for Regional Anesthesia) guidelines
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: A Randomized-controlled, Double-blind, Single-center Trial Comparing Impact of PENG Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty
Total hip arthroplasty (THA) is now the second most common joint replacement surgery in the US due in part to an aging population. Opioid sparing analgesic treatments such as lumbar plexus and femoral nerve blocks are effective but they carry a high risk of undesirable lower limb motor or muscle weakness. Fascia iliaca block, on the other hand, does not consistently provide adequate pain relief. Today, early mobilization, rehabilitation and participation in physical therapy is an integral part of enhanced functional recovery program after THA. Because innervation of the hip joint is complex and preservation of lower extremity motor function is paramount, optimal regional analgesic intervention for THA has yet to be defined. The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties. Quality of recovery scores are patient reported outcome measures evaluating recovery after surgery and anesthesia. The quality of recovery-15 (QoR-15) is a validated questionnaire to assess postoperative recovery. The aim of this single center, double blind, randomized controlled trial is to confirm the efficacy of the PENG block for postoperative recovery after primary THA.
Methods: The participants will be randomly assigned to either PENG block group or "no Block" group using a random number generator. The patient will be blinded to the group allocated. The primary outcome will be the quality of recovery 15 score (QoR-15). The secondary outcomes will be visual analog scale score of pain postoperatively, opioid requirements in first 24 hours, ambulation distance on postoperative day1 and patient satisfaction. Statistical analysis will be performed using the student's t-test, Mann-Whitney U test, and Fisher's exact test as appropriate per sample. A p-value of less than 0.05 will be considered statistically significant.
Read the detailed description
As the practice of anesthesiology has grown increasingly safe, the focus has shifted to improving quality, as evidenced by the robust spread of Enhanced Recovery after Surgery protocols. The implications from poor quality recovery is vast, including prolonged stay in the recovery room or hospital. The Quality of Recovery (QoR-15) questionnaire is a method to measure five dimensions using 15 questions: physical independence, pain, comfort, patient support, emotional state. It is an extensively validated measure of patient-assessed quality of recovery after surgery, having been demonstrated over a variety of clinical settings. QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent). Mean time to complete the 15-question survey is 3 minutes, a marker of its clinical utility. As we aim to improve our perioperative care and develop approaches to improve medicine in this regard, the QoR-15 provides a useful tool.
The effective postoperative analgesia is vital as acute surgical pain is a potential risk factor for future chronic pain. Persistent pain after THA (more than three months) is reported in 27% of patients and is reported to be correlated with the intensity of early postoperative pain rather than preoperative pain levels. Utilizing regional anesthesia helps to limit the use of opioids, however, which technique is best has yet to be determined. The lumbar plexus blocks, lumbar epidurals, and femoral nerve blocks have been associated with motor weakness. Fascia iliaca compartment block (FICB) has not been found to predictably decrease pain intensity or opioid use. Quadratus lumborum (QL) block is a relatively new regional block found to provide effective analgesia after primary THA, but it can indirectly block lumbar plexus branches and may cause some motor weakness. It is also a deep block and therefore contraindicated in patients on anticoagulation.
Recent anatomic studies confirmed the innervation of the anterior capsule of hip joint to be the obturator nerve, accessory obturator nerve, and femoral nerve. These studies also evaluated the relationship with these nerves and other bony or soft tissue landmarks visible by ultrasound guidance. Previous studies have found histologically that the anterior capsule has predominantly nociceptive fibers, while the posterior capsule is largely made up of mechanoreceptors. The pericapsular nerve group (PENG) block was introduced to target and block these articular branches providing innervation to the hip. Given the case reports showing the efficacy of PENG blocks for hip fracture surgeries, we sought to investigate the analgesic efficacy of PENG blocks for primary and revision THAs. The PENG block targets only the sensory branches and not the posterior mechanoreceptors; there is a potential motor-sparing effect which is desirable for early ambulation, better physical therapy, and earlier discharge. The effective analgesia and early ambulation provided by such regional anesthesia block may have positive impact on patient's mood, sleep, appetite and overall feeling of well-being. A similar postoperative recovery study protocol has been proposed for anterior quadratus lumborum blocks for THA. It remains unclear whether PENG block provides sufficient analgesia and improves the quality of post-operative recovery after primary THA.
The ideal regional anesthesia technique for THA will provide adequate postoperative analgesia, reduced opioid requirements, early ambulation and physical independence. The aim of this single center, double blind RCT is to confirm the efficacy of PENG block for postoperative recovery with respect to parameters mentioned above.
- Conditions
- Total Hip Arthroplasty
- Being tested
- PENG Block, Lidocaine
- Keywords
- PENG, THA, nerve blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockDrug
The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.
LidocaineDrug
2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Investigational group ("PENG Block" group) | Experimental | Participants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17). Receives: Drug: PENG Block |
| Control group | Active comparator | Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection.
Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery After Total Hip Arthroplasty
The quality of recovery-15 is a validated questionnaire to assess postoperative recovery. I Scale is based on 15 questions, each question score range is 0-10 (0 being poor and 10 being excellent) The survey will be conducted at 24 hours after surgery Total score range is 0-150, where a score of 0 would be the worst possible score, and 150 would be the best possible score.
Measured: 24 hours after surgery
Secondary outcomes (5)
Evaluating Recovery After Total Hip Arthroplasty
Quality of recovery (QoR) survey at 48 hours after surgery. QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).
Measured: 2 days after surgery
Average Pain Medicine Required After Surgery.
Measuring the average milligrams of oral morphine equivalent (OME) consumption at 24 and 48 hours after surgery
Measured: 24 and 48 hours after surgery
Pain Scores After Surgery
Pain scores (visual analog scores VAS) in recovery (PACU), 6, 12, 24 and 48 hours after surgery
Measured: Recovery (PACU), 6, 12, 24 and 48 hours after surgery
Ambulation Distance After Surgery
ambulation distance as recorded by physical therapist at 24 and 48 hours after surgery
Measured: 24 and 48 hours after surgery
Total Patients Using Antiemetics After Surgery
use of any medication for nausea or vomiting prevention after surgery
Measured: up to 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Feb 2021
- Primary completion15 Sep 2022
- Study completion1 Nov 2022
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 (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Promil Kukreja, University of Alabama at Birmingham
- Investigators
- Shana Graves, Study director, UAB shannagraves@uabmc.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591353
- Sponsor's protocol ID
- IRB-300006163
- Acronym
- (PENG)
- Status last verified
- Jul 2023
- First submitted
- 9 Oct 2020
- Last updated
- 15 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kukreja P, Uppal V, Kofskey AM, Feinstein J, Northern T, Davis C, Morgan CJ, Kalagara H. Quality of recovery after pericapsular nerve group (PENG) block for primary total hip arthroplasty under spinal anaesthesia: a randomised controlled observer-blinded trial. Br J Anaesth. 2023 Jun;130(6):773-779. doi: 10.1016/j.bja.2023.02.017. Epub 2023 Mar 22.
PubMed 36964012
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-controlled, Double-blind, Single-center Trial Comparing Impact of PENG Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04591353
- Acronym / sponsor ID
- (PENG) / IRB-300006163
- Conditions
- Total Hip Arthroplasty
- Keywords
- PENG, THA, nerve blocks
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 17 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total hip arthroplasty (THA) is now the second most common joint replacement surgery in the US due in part to an aging population. Opioid sparing analgesic treatments such as lumbar plexus and femoral nerve blocks are effective but they carry a high risk of undesirable lower limb motor or muscle weakness. Fascia iliaca block, on the other hand, does not consistently provide adequate pain relief. Today, early mobilization, rehabilitation and participation in physical therapy is an integral part of enhanced functional recovery program after THA. Because innervation of the hip joint is complex and preservation of lower extremity motor function is paramount, optimal regional analgesic intervention for THA has yet to be defined. The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties. Quality of recovery scores are patient reported outcome measures evaluating recovery after surgery and anesthesia. The quality of recovery-15 (QoR-15) is a validated questionnaire to assess postoperative recovery. The aim of this single center, double blind, randomized controlled trial is to confirm the efficacy of the PENG block for postoperative recovery after primary THA.
Methods: The participants will be randomly assigned to either PENG block group or "no Block" group using a random number generator. The patient will be blinded to the group allocated. The primary outcome will be the quality of recovery 15 score (QoR-15). The secondary outcomes will be visual analog scale score of pain postoperatively, opioid requirements in first 24 hours, ambulation distance on postoperative day1 and patient satisfaction. Statistical analysis will be performed using the student's t-test, Mann-Whitney U test, and Fisher's exact test as appropriate per sample. A p-value of less than 0.05 will be considered statistically significant.
Detailed description
As the practice of anesthesiology has grown increasingly safe, the focus has shifted to improving quality, as evidenced by the robust spread of Enhanced Recovery after Surgery protocols. The implications from poor quality recovery is vast, including prolonged stay in the recovery room or hospital. The Quality of Recovery (QoR-15) questionnaire is a method to measure five dimensions using 15 questions: physical independence, pain, comfort, patient support, emotional state. It is an extensively validated measure of patient-assessed quality of recovery after surgery, having been demonstrated over a variety of clinical settings. QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent). Mean time to complete the 15-question survey is 3 minutes, a marker of its clinical utility. As we aim to improve our perioperative care and develop approaches to improve medicine in this regard, the QoR-15 provides a useful tool.
The effective postoperative analgesia is vital as acute surgical pain is a potential risk factor for future chronic pain. Persistent pain after THA (more than three months) is reported in 27% of patients and is reported to be correlated with the intensity of early postoperative pain rather than preoperative pain levels. Utilizing regional anesthesia helps to limit the use of opioids, however, which technique is best has yet to be determined. The lumbar plexus blocks, lumbar epidurals, and femoral nerve blocks have been associated with motor weakness. Fascia iliaca compartment block (FICB) has not been found to predictably decrease pain intensity or opioid use. Quadratus lumborum (QL) block is a relatively new regional block found to provide effective analgesia after primary THA, but it can indirectly block lumbar plexus branches and may cause some motor weakness. It is also a deep block and therefore contraindicated in patients on anticoagulation.
Recent anatomic studies confirmed the innervation of the anterior capsule of hip joint to be the obturator nerve, accessory obturator nerve, and femoral nerve. These studies also evaluated the relationship with these nerves and other bony or soft tissue landmarks visible by ultrasound guidance. Previous studies have found histologically that the anterior capsule has predominantly nociceptive fibers, while the posterior capsule is largely made up of mechanoreceptors. The pericapsular nerve group (PENG) block was introduced to target and block these articular branches providing innervation to the hip. Given the case reports showing the efficacy of PENG blocks for hip fracture surgeries, we sought to investigate the analgesic efficacy of PENG blocks for primary and revision THAs. The PENG block targets only the sensory branches and not the posterior mechanoreceptors; there is a potential motor-sparing effect which is desirable for early ambulation, better physical therapy, and earlier discharge. The effective analgesia and early ambulation provided by such regional anesthesia block may have positive impact on patient's mood, sleep, appetite and overall feeling of well-being. A similar postoperative recovery study protocol has been proposed for anterior quadratus lumborum blocks for THA. It remains unclear whether PENG block provides sufficient analgesia and improves the quality of post-operative recovery after primary THA.
The ideal regional anesthesia technique for THA will provide adequate postoperative analgesia, reduced opioid requirements, early ambulation and physical independence. The aim of this single center, double blind RCT is to confirm the efficacy of PENG block for postoperative recovery with respect to parameters mentioned above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational group ("PENG Block" group) | Experimental | Drug: PENG BlockParticipants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17). |
| Control group | Active comparator | Drug: LidocaineControl group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection. Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing primary total hip arthroplasty
- Patients >=18 years of age
- Patients with an American Society of Anesthesiology (ASA) physical status classification of I, II or III
- Primary THA (first THA operation in the patient's lifetime)
Key exclusion criteria (7 listed)
- Patients with ASA physical status classification 4 or above
- Patients with allergies/intolerances to local anesthetic
- Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the surgical site
- Patients on chronic opioid use or opioid tolerant (The FDA defines a patient as opioid tolerant if for at least 1 week he or she has been receiving oral morphine 60 mg/day; transdermal fentanyl 25 mcg/hour; oral oxycodone 30 mg/day; oral hydromorphone 8 mg/day; oral oxymorphone 25 mg/day; or an equianalgesic dose of any other opioid)
- Poor understanding of English language.
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 |
|---|---|---|
| PENG BlockThe pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties. | Drug | Investigational group ("PENG Block" group) |
| Lidocaine2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. | Drug | Control group |
Primary outcome
Recovery After Total Hip Arthroplasty
Time frame: 24 hours after surgery
The quality of recovery-15 is a validated questionnaire to assess postoperative recovery. I Scale is based on 15 questions, each question score range is 0-10 (0 being poor and 10 being excellent) The survey will be conducted at 24 hours after surgery Total score range is 0-150, where a score of 0 would be the worst possible score, and 150 would be the best possible score.
5 secondary outcomes
Evaluating Recovery After Total Hip Arthroplasty
Time frame: 2 days after surgery
Average Pain Medicine Required After Surgery.
Time frame: 24 and 48 hours after surgery
Pain Scores After Surgery
Time frame: Recovery (PACU), 6, 12, 24 and 48 hours after surgery
Ambulation Distance After Surgery
Time frame: 24 and 48 hours after surgery
Total Patients Using Antiemetics After Surgery
Time frame: up to 2 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36964012Kukreja P, Uppal V, Kofskey AM, Feinstein J, Northern T, Davis C, Morgan CJ, Kalagara H. Quality of recovery after pericapsular nerve group (PENG) block for primary total hip arthroplasty under spinal anaesthesia: a randomised controlled observer-blinded trial. Br J Anaesth. 2023 Jun;130(6):773-779. doi: 10.1016/j.bja.2023.02.017. Epub 2023 Mar 22.
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Total Hip Arthroplasty (THA)
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.
Shana Graves study director
UAB shannagraves@uabmc.edu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PENG Block and Lidocaine in people with Total Hip Arthroplasty, run by University of Alabama at Birmingham at 2 sites in United States.
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 4 inclusion and 7 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 15 Feb 2024. 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 States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2023). 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?
Recovery After Total Hip Arthroplasty (time frame: 24 hours 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 NCT04591353, which also lists 1 linked publication.
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 Feb 2024.