Hamstring Tendon InjuryPHACTNCT03311997
The Proximal Hamstring Avulsion Clinical Trial - Operative or Nonoperative Treatment
A study testing Surgical reattachment of hamstring tendons in people with Hamstring Tendon Injury, run by Uppsala University at 10 sites in 2 countries.
Trial summary
The purpose of this study is to provide reliable evidence on how to best treat proximal hamstrings avulsions, and our primary aim is to compare the reported outcome of patients treated non-operatively with patients treated with suture anchor reattachment of the tendons using the Perth Hamstrings Assessment Tool (PHAT)… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hamstring Tendon Injury
- What is being tested?
- Surgical reattachment of hamstring tendons
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 24 Oct 2017to 22 Sep 2022
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of the patient at injury between 30 and 70
- MRI shows a complete avulsion of at least two of three tendons from the insertion at the ischial tubercule
- physical examination supports the diagnosis; e.g. a positive hip extension test, palpable defect and/or local tenderness and hematoma
- patient has a moderate to high activity level
- patient has linguistic and mental ability to understands study program explained in Swedish, Finnish, Norwegian or English
- time from injury to inclusion in study is less than 4 weeks
- A patient with moderate to high activity level is defined as any patient that is ambulatory in the community and participates in some type of strenuous activity at work or in spare time on a regular basis. Any patient that skis, goes for an occasional run, takes long walks in the woods, climbs ladders or physically manages a large garden have an activity level that is at least moderate.
Who cannot join
- diabetes with secondary complications
- previous major lower extremity injury or disease with sequelae
- moderate or severe liver, pulmonary, kidney, psychiatric or heart disease that significantly increases the risk for complications after operative treatment
- severe obesity (BMI>35)
- alcohol or drug abuse
- high energy injury or combinations of injuries affecting the lower extremity
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Sweden8 sites
Linköping University Hospital
Linköping, 581 85
Malmö University Hospital
Malmö
Örebro University Hospital
Örebro, 701 85
Östersund Hospital
Östersund, 831 83
Södersjukhuset
Stockholm, 118 83
Danderyd hospital
Stockholm, 182 88
Norrlands University Hospital
Umeå, 581 85
Uppsala University Hospital
Uppsala, 75185
About this study
Official title: The Proximal Hamstring Avulsion Clinical Trial - Nonoperative Treatment Compared With Suture Anchor Reinsertion of Proximal Hamstrings Avulsions
The purpose of this study is to provide reliable evidence on how to best treat proximal hamstrings avulsions, and our primary aim is to compare the reported outcome of patients treated non-operatively with patients treated with suture anchor reattachment of the tendons using the Perth Hamstrings Assessment Tool (PHAT) at 24 months.
Read the detailed description
The treatment of proximal hamstrings avulsions is controversial and patients with this injury will get treatment recommendations based not on scientific evidence but on personal preferences of their surgeon. The literature is totally devoid of studies comparing the two treatment options; non-operative and operative treatment. In Sweden, it is probably more common to treat these injuries nonoperatively. This is in contrast to existing literature that suggests that better outcomes are expected with operative treatment. However, there is a very clear publication bias in the literature. In fact, of the more than 40 published clinical studies, only a handful mentions the results of non-operatively treated injuries.
In a systematic review examining 13 original studies, patient satisfaction ranged from 88% to 100% after surgical treatment. In nine of the studies strength of hamstrings were reported and ranged from 78% to 101% of the uninjured side. However, residual pain is common, ranging from 8 to 61% in a group of 203 patients and in a recent unpublished study the lower extremity functional score were similar in patients treated by either modality. Additionally, serious nerve injuries after surgery have been reported and infection, anchor failure and re-rupture occur. The reoperation rate in a study by Sarimo et al. was 12%.
This study is a prospective, multicentre, preference-tolerant, randomized controlled, non-inferiority trial comparing operative to non-operative treatment of proximal hamstrings avulsions. The study will include a concurrent prospective observational cohort.
The eligible study population will consist of patients with an acute, avulsion of hamstrings tendons diagnosed in a hospital in Sweden, or Norway and subsequently referred to one of the study sites. All patients fulfilling the inclusion and not meeting the exclusion criteria will be asked to participate in the study. After the patient´s enrolment has been confirmed and informed consent is obtained a set of questionnaires is provided for background data on medical history, activity levels and a recall assessment of the pre-injury functional status. When these questionnaires are completed, the patient is randomized.
If the patient is randomized to non-operative treatment an appointment with a physiotherapist follows and the study rehabilitation protocol is explained. If the patient is randomized to surgery, the procedure is scheduled at the earliest convenient time but no later than 2 weeks from inclusion. The surgical procedure and rehabilitation protocol is standardized among sites. The same rehabilitation protocol is used for both treatment groups.
Participation in this study will last 24 months. In-person participant follow-up visits will occur at enrollment (baseline), at-surgery, 3 months, 6 months, 12 months and 24 months post-surgery. Data for outcomes will be collected at follow-up visit and a MRI will be performed at 24 months.
- Conditions
- Hamstring Tendon Injury
- Being tested
- Surgical reattachment of hamstring tendons
- Keywords
- RCT, Hamstring, Suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical reattachment of hamstring tendonsProcedure or surgery
operatively reattachment of the tendons using suture anchor
| Study group | Role | What they receive |
|---|---|---|
| Non-operative treatment | No intervention | Active rehabilitation program |
| Operative treatment | Active comparator | Surgical reattachment of hamstring tendons using suture anchors followed by active rehabilitation program Receives: Procedure: Surgical reattachment of hamstring tendons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perth Hamstrings Assessment Tool (PHAT)
The PHAT is a 8-item instrument that measures pain, function and discomfort of the hamstrings. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months). The maximum score is 100 indicating no symptoms and high function.
Measured: 24 months post inclusion
Secondary outcomes (5)
Lower extremity functional scale (LEFS)
LEFS is a 30-item instrument that measure patient perceived function of the lower extremities. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months). The maximum possible score is 80 points, indicating very high function.
Measured: 24 months post inclusion
Maximal isokinetic strength of hamstrings
The difference between the two treatment groups in the mean ratio between the injured and uninjured side of the maximum isokinetic force during knee flexion and hip extension measured by a dynamometer. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months).
Measured: 24 months post inclusion
Timed step test
The difference between the two treatment groups in the mean ratio between the injured and uninjured side of the functional timed step test. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months).
Measured: 24 months post inclusion
Single hop test
The difference between the two treatment groups in the mean ratio between the injured and uninjured side of the single leg hop test. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months).
Measured: 24 months post inclusion
Hamstrings muscle volume and density
Volume and density measured by DIXON MRI at 24 months
Measured: 24 months post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start24 Oct 2017
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hamstring Tendon InjuryStudies of the same condition, open and under way.
- More trials run by Uppsala 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Lund University, Örebro University, Sweden, Umeå University, Karolinska Institutet, University of Oslo, University of Bergen
- Responsible party
- Sponsor
- Investigators
- Kenneth Jonsson, MD., Ph.D, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311997
- Sponsor's protocol ID
- UU2017/170
- Acronym
- PHACT
- Status last verified
- Apr 2024
- First submitted
- 10 Oct 2017
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Publications
Iyer VG. Iatrogenic injury to the sciatic nerve during surgical repair of proximal hamstring avulsion. Muscle Nerve. 2015 Sep;52(3):465-6. doi: 10.1002/mus.24678. Epub 2015 May 14. No abstract available.
PubMed 25847226Blakeney WG, Zilko SR, Edmonston SJ, Schupp NE, Annear PT. Proximal hamstring tendon avulsion surgery: evaluation of the Perth Hamstring Assessment Tool. Knee Surg Sports Traumatol Arthrosc. 2017 Jun;25(6):1936-1942. doi: 10.1007/s00167-016-4214-y. Epub 2016 Jun 25.
PubMed 27344550Harris JD, Griesser MJ, Best TM, Ellis TJ. Treatment of proximal hamstring ruptures - a systematic review. Int J Sports Med. 2011 Jul;32(7):490-5. doi: 10.1055/s-0031-1273753. Epub 2011 May 11.
PubMed 21563032Barry MJ, Palmer WE, Petruska AJ. A Proximal Hamstring Injury--Getting Off a Slippery Slope. JAMA Intern Med. 2016 Jan;176(1):15-6. doi: 10.1001/jamainternmed.2015.6795. No abstract available.
PubMed 26618607Mehta SP, Fulton A, Quach C, Thistle M, Toledo C, Evans NA. Measurement Properties of the Lower Extremity Functional Scale: A Systematic Review. J Orthop Sports Phys Ther. 2016 Mar;46(3):200-16. doi: 10.2519/jospt.2016.6165. Epub 2016 Jan 26.
PubMed 26813750Sarimo J, Lempainen L, Mattila K, Orava S. Complete proximal hamstring avulsions: a series of 41 patients with operative treatment. Am J Sports Med. 2008 Jun;36(6):1110-5. doi: 10.1177/0363546508314427. Epub 2008 Mar 4.
PubMed 18319349van der Made AD, Reurink G, Gouttebarge V, Tol JL, Kerkhoffs GM. Outcome After Surgical Repair of Proximal Hamstring Avulsions: A Systematic Review. Am J Sports Med. 2015 Nov;43(11):2841-51. doi: 10.1177/0363546514555327. Epub 2014 Nov 10.
PubMed 25384502Laszlo S, Rosenlund AM, Pihl E, Kristoffersen MH, Skoldenberg O, Schilcher J, Eklund M, Frihagen F, Skorpil M, Jonsson KB. Initial Tendon Retraction is Associated with Muscle Degeneration After Nonoperatively Treated Proximal Hamstring Avulsions. Sports Med Open. 2026 May 6;12(1):52. doi: 10.1186/s40798-026-01024-x.
PubMed 42089934Pihl E, Laszlo S, Rosenlund AM, Kristoffersen MH, Schilcher J, Hedbeck CJ, Skorpil M, Micoli C, Eklund M, Skoldenberg O, Frihagen F, Jonsson KB. Operative versus Nonoperative Treatment of Proximal Hamstring Avulsions. NEJM Evid. 2024 Aug;3(8):EVIDoa2400056. doi: 10.1056/EVIDoa2400056. Epub 2024 Jul 18.
PubMed 39023393Pihl E, Kristoffersen MH, Rosenlund AM, Laszlo S, Berglof M, Ribom E, Eriksson K, Frihagen F, Mattila VM, Schilcher J, Eklund M, Snellman G, Skorpil M, Skoldenberg O, Hedbeck CJ, Jonsson K. The proximal hamstring avulsion clinical trial (PHACT)-a randomised controlled non-inferiority trial of operative versus non-operative treatment of proximal hamstrings avulsions: study protocol. BMJ Open. 2019 Sep 13;9(9):e031607. doi: 10.1136/bmjopen-2019-031607.
PubMed 31519683
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Proximal Hamstring Avulsion Clinical Trial - Nonoperative Treatment Compared With Suture Anchor Reinsertion of Proximal Hamstrings Avulsions
- ClinicalTrials.gov ID
- NCT03311997
- Acronym / sponsor ID
- PHACT / UU2017/170
- Conditions
- Hamstring Tendon Injury
- Keywords
- RCT, Hamstring, Suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University, Lund University, Örebro University, Sweden, Umeå University, Karolinska Institutet, University of Oslo, University of Bergen
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 17 Oct 2017 (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 this study is to provide reliable evidence on how to best treat proximal hamstrings avulsions, and our primary aim is to compare the reported outcome of patients treated non-operatively with patients treated with suture anchor reattachment of the tendons using the Perth Hamstrings Assessment Tool (PHAT) at 24 months.
Detailed description
The treatment of proximal hamstrings avulsions is controversial and patients with this injury will get treatment recommendations based not on scientific evidence but on personal preferences of their surgeon. The literature is totally devoid of studies comparing the two treatment options; non-operative and operative treatment. In Sweden, it is probably more common to treat these injuries nonoperatively. This is in contrast to existing literature that suggests that better outcomes are expected with operative treatment. However, there is a very clear publication bias in the literature. In fact, of the more than 40 published clinical studies, only a handful mentions the results of non-operatively treated injuries.
In a systematic review examining 13 original studies, patient satisfaction ranged from 88% to 100% after surgical treatment. In nine of the studies strength of hamstrings were reported and ranged from 78% to 101% of the uninjured side. However, residual pain is common, ranging from 8 to 61% in a group of 203 patients and in a recent unpublished study the lower extremity functional score were similar in patients treated by either modality. Additionally, serious nerve injuries after surgery have been reported and infection, anchor failure and re-rupture occur. The reoperation rate in a study by Sarimo et al. was 12%.
This study is a prospective, multicentre, preference-tolerant, randomized controlled, non-inferiority trial comparing operative to non-operative treatment of proximal hamstrings avulsions. The study will include a concurrent prospective observational cohort.
The eligible study population will consist of patients with an acute, avulsion of hamstrings tendons diagnosed in a hospital in Sweden, or Norway and subsequently referred to one of the study sites. All patients fulfilling the inclusion and not meeting the exclusion criteria will be asked to participate in the study. After the patient´s enrolment has been confirmed and informed consent is obtained a set of questionnaires is provided for background data on medical history, activity levels and a recall assessment of the pre-injury functional status. When these questionnaires are completed, the patient is randomized.
If the patient is randomized to non-operative treatment an appointment with a physiotherapist follows and the study rehabilitation protocol is explained. If the patient is randomized to surgery, the procedure is scheduled at the earliest convenient time but no later than 2 weeks from inclusion. The surgical procedure and rehabilitation protocol is standardized among sites. The same rehabilitation protocol is used for both treatment groups.
Participation in this study will last 24 months. In-person participant follow-up visits will occur at enrollment (baseline), at-surgery, 3 months, 6 months, 12 months and 24 months post-surgery. Data for outcomes will be collected at follow-up visit and a MRI will be performed at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-operative treatment | No intervention | –Active rehabilitation program |
| Operative treatment | Active comparator | Procedure: Surgical reattachment of hamstring tendonsSurgical reattachment of hamstring tendons using suture anchors followed by active rehabilitation program |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age of the patient at injury between 30 and 70
- MRI shows a complete avulsion of at least two of three tendons from the insertion at the ischial tubercule
- physical examination supports the diagnosis; e.g. a positive hip extension test, palpable defect and/or local tenderness and hematoma
- patient has a moderate to high activity level
- patient has linguistic and mental ability to understands study program explained in Swedish, Finnish, Norwegian or English
Key exclusion criteria (6 listed)
- diabetes with secondary complications
- previous major lower extremity injury or disease with sequelae
- moderate or severe liver, pulmonary, kidney, psychiatric or heart disease that significantly increases the risk for complications after operative treatment
- severe obesity (BMI>35)
- alcohol or drug abuse
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 |
|---|---|---|
| Surgical reattachment of hamstring tendonsoperatively reattachment of the tendons using suture anchor | Procedure or surgery | Operative treatment |
Primary outcome
Perth Hamstrings Assessment Tool (PHAT)
Time frame: 24 months post inclusion
The PHAT is a 8-item instrument that measures pain, function and discomfort of the hamstrings. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months). The maximum score is 100 indicating no symptoms and high function.
5 secondary outcomes
Lower extremity functional scale (LEFS)
Time frame: 24 months post inclusion
Maximal isokinetic strength of hamstrings
Time frame: 24 months post inclusion
Timed step test
Time frame: 24 months post inclusion
Single hop test
Time frame: 24 months post inclusion
Hamstrings muscle volume and density
Time frame: 24 months post inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Background: PubMed 25847226Iyer VG. Iatrogenic injury to the sciatic nerve during surgical repair of proximal hamstring avulsion. Muscle Nerve. 2015 Sep;52(3):465-6. doi: 10.1002/mus.24678. Epub 2015 May 14. No abstract available.
- Background: PubMed 27344550Blakeney WG, Zilko SR, Edmonston SJ, Schupp NE, Annear PT. Proximal hamstring tendon avulsion surgery: evaluation of the Perth Hamstring Assessment Tool. Knee Surg Sports Traumatol Arthrosc. 2017 Jun;25(6):1936-1942. doi: 10.1007/s00167-016-4214-y. Epub 2016 Jun 25.
- Background: PubMed 21563032Harris JD, Griesser MJ, Best TM, Ellis TJ. Treatment of proximal hamstring ruptures - a systematic review. Int J Sports Med. 2011 Jul;32(7):490-5. doi: 10.1055/s-0031-1273753. Epub 2011 May 11.
- Background: PubMed 26618607Barry MJ, Palmer WE, Petruska AJ. A Proximal Hamstring Injury--Getting Off a Slippery Slope. JAMA Intern Med. 2016 Jan;176(1):15-6. doi: 10.1001/jamainternmed.2015.6795. No abstract available.
- Background: PubMed 26813750Mehta SP, Fulton A, Quach C, Thistle M, Toledo C, Evans NA. Measurement Properties of the Lower Extremity Functional Scale: A Systematic Review. J Orthop Sports Phys Ther. 2016 Mar;46(3):200-16. doi: 10.2519/jospt.2016.6165. Epub 2016 Jan 26.
- Background: PubMed 18319349Sarimo J, Lempainen L, Mattila K, Orava S. Complete proximal hamstring avulsions: a series of 41 patients with operative treatment. Am J Sports Med. 2008 Jun;36(6):1110-5. doi: 10.1177/0363546508314427. Epub 2008 Mar 4.
- Background: PubMed 25384502van der Made AD, Reurink G, Gouttebarge V, Tol JL, Kerkhoffs GM. Outcome After Surgical Repair of Proximal Hamstring Avulsions: A Systematic Review. Am J Sports Med. 2015 Nov;43(11):2841-51. doi: 10.1177/0363546514555327. Epub 2014 Nov 10.
- Derived from this study: PubMed 42089934Laszlo S, Rosenlund AM, Pihl E, Kristoffersen MH, Skoldenberg O, Schilcher J, Eklund M, Frihagen F, Skorpil M, Jonsson KB. Initial Tendon Retraction is Associated with Muscle Degeneration After Nonoperatively Treated Proximal Hamstring Avulsions. Sports Med Open. 2026 May 6;12(1):52. doi: 10.1186/s40798-026-01024-x.
- Derived from this study: PubMed 39023393Pihl E, Laszlo S, Rosenlund AM, Kristoffersen MH, Schilcher J, Hedbeck CJ, Skorpil M, Micoli C, Eklund M, Skoldenberg O, Frihagen F, Jonsson KB. Operative versus Nonoperative Treatment of Proximal Hamstring Avulsions. NEJM Evid. 2024 Aug;3(8):EVIDoa2400056. doi: 10.1056/EVIDoa2400056. Epub 2024 Jul 18.
- Derived from this study: PubMed 31519683Pihl E, Kristoffersen MH, Rosenlund AM, Laszlo S, Berglof M, Ribom E, Eriksson K, Frihagen F, Mattila VM, Schilcher J, Eklund M, Snellman G, Skorpil M, Skoldenberg O, Hedbeck CJ, Jonsson K. The proximal hamstring avulsion clinical trial (PHACT)-a randomised controlled non-inferiority trial of operative versus non-operative treatment of proximal hamstrings avulsions: study protocol. BMJ Open. 2019 Sep 13;9(9):e031607. doi: 10.1136/bmjopen-2019-031607.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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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.
Kenneth Jonsson, MD., Ph.D principal investigator
Uppsala University
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical reattachment of hamstring tendons in people with Hamstring Tendon Injury, run by Uppsala University at 10 sites in 2 countries.
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 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Sweden, Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perth Hamstrings Assessment Tool (PHAT) (time frame: 24 months post inclusion). 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 NCT03311997, which also lists 10 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 11 Apr 2024.