Anterior Cruciate Ligament TearNCT05088278
Long Term Clinical and Radiographical Outcomes of Different Anterior Cruciate Ligament Reconstruction Techniques
A study testing Anatomical single bundle ACL reconstruction with hamstrings, Anatomical single bundle ACL reconstruction with patellar tendon and ACL reconstruction with over the top plus lateral plasty technique in people with Anterior Cruciate Ligament Tear and Osteoarthritis, Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the long-term results of various anterior cruciate ligament reconstruction techniques. This assessment is necessary for the current context of anterior cruciate ligament research as several techniques and grafts are used in clinical practice, however, the various studies… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear, Osteoarthritis, Knee
- What is being tested?
- Anatomical single bundle ACL reconstruction with hamstrings, Anatomical single bundle ACL reconstruction with patellar tendon and ACL reconstruction with over the top plus lateral plasty technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 27 Jul 2023
- 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
- Patients who underwent ACL reconstruction with single-bundle anatomical technique (patellar tendon, semitendinous and gracile tendons) or "Over-The-Top plus lateral plastic" technique and any associated procedures with at least 15 years of follow up;
- Patients aged between 15 and 50 at the time of surgery;
- Patients with isolated ACL tear;
- Patients with healthy contralateral knee at the time of surgery.
Who cannot join
- Patients with grade III-IV chondral lesions according to Outerbridge scale at surgery;
- Patients no longer available;
- Women of childbearing age who cannot exclude pregnancy;
- Patients unable to give informed consent or patients unwilling to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the long-term results of various anterior cruciate ligament reconstruction techniques. This assessment is necessary for the current context of anterior cruciate ligament research as several techniques and grafts are used in clinical practice, however, the various studies existing in the literature focus mainly only on the direct comparison of two techniques and usually with short-to-medium term follow-up. Since gonarthrosis is one of the most debated consequences of cruciate ligament reconstruction, a comparison of different long-term procedures would be desirable to have a clearer picture of the risks and benefits associated with different types of intervention.
Read the detailed description
In the beginning, the Database of our Institute is consulted, all the patients that underwent ACL reconstruction at least 15 years ago are selected. The original group will be divided into subgroups based on the surgical technique adopted, of the different techniques we took into consideration only these three: anatomical ACL reconstruction with patellar tendon, anatomical ACL reconstruction with hamstrings, non-anatomical ACL reconstruction "Over-the-top plus lateral plasty". The patients will be contacted to ask if they are interested to take part in the study; at least 25 patients for each group will be recruited. All the patients recruited will sign an informed consent about the study and the personal data treatment. After consent acquisition, patients will undergo a clinical examination and a questionnaire about pain and knee status will be administered; moreover, a radiographical examination of the operated knee will be performed to assess the osteoarthritis progression. Patients that reported graft rupture will be registered as failures.
- Being tested
- Anatomical single bundle ACL reconstruction with hamstrings, Anatomical single bundle ACL reconstruction with patellar tendon, ACL reconstruction with over the top plus lateral plasty technique
- Keywords
- anterior cruciate ligament, knee osteoarthritis, hamstrings, patellar tendon, lateral extra articular tenodesis
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical single bundle ACL reconstruction with hamstringsProcedure or surgery
Anatomical ACL reconstruction with quadruple-bundle hamstrings graft
Anatomical single bundle ACL reconstruction with patellar tendonProcedure or surgery
Anatomical single bundle ACL reconstruction with patellar tendon
ACL reconstruction with over the top plus lateral plasty techniqueProcedure or surgery
Non-anatomical ACL reconstruction, the hamstrings' tibial insertion is preserved; a double-bundle hamstring graft is passed intra-articularly, fixed in over the top position on the lateral femoral condyle, and then passed extra-articularly deeply to ileo-tibial band up to the tibia, where it is fixed at the level of Gerdy's tubercle.
| Study group | Role | What they receive |
|---|---|---|
| HS | Active comparator | Patients who underwent anatomical single-bundle ACL reconstruction with hamstrings Receives: Procedure: Anatomical single bundle ACL reconstruction with hamstrings |
| BPT | Active comparator | Patients who underwent anatomical single-bundle ACL reconstruction with patellar tendon Receives: Procedure: Anatomical single bundle ACL reconstruction with patellar tendon |
| Over-the-top plus lateral plasty | Experimental | Patients who underwent ACL reconstruction with Over-the-top plus lateral plasty technique Receives: Procedure: ACL reconstruction with over the top plus lateral plasty technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective and objective International Knee Documentation Committee
Clinical scores widely used to assess knee function and symptoms Values: 0 (worst score) to 100 (best score) for subjective IKDC; A (best score)-B-C-D (worst score) for objective IKDC (International Knee Documentation Committee)
Measured: Two years
VAS pain
Numerical score to quantitatively assess the intensity of pain (0-10)
Measured: Two years
Kellgreen-Lawrence
Radiographical score that graded knee ostheoarthritis
Measured: Two years
Knee Laxity
Assessment of knee anterior posterior laxity and quantification of Pivot shift using measurement devices (KT-1000; Kira)
Measured: Two years
Failure and complications
Failures and complication rate for each arm of the study
Measured: Two years
Secondary outcomes (6)
Short Form-36 Health Survey
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.
Measured: Two years
Anterior knee pain
The patients will report in dicotomic way (yes/no) the presence/absence of pain referred to patello-femural joint.
Measured: Two years
Global satisfaction about the surgical procedure
The patients will report in dicotomic way (yes/no) if they are satisfied with the surgical procedure results
Measured: Two years
Tight circumference
Tight circumference measured 5 cm and 15 cm above the patella; it is a direct measurement of quadriceps trophism and indirectly explore the muscular status of affected limb.
Measured: Two years
Lysholm knee scoring scale
Clinical score used to assess knee function in context of ligamentary and meniscal lesions Values: 0 (worst score) to 100 (best score)
Measured: Two years
Tegner activity scale
Score that graded activity based on work and sports referred to knee status Values: 0 (worst score) to 10 (best score)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Apr 2021
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Zaffagnini, MD Prof, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088278
- Sponsor's protocol ID
- Long term ACLR
- Status last verified
- Jul 2023
- First submitted
- 12 Oct 2021
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Samuelsen BT, Webster KE, Johnson NR, Hewett TE, Krych AJ. Hamstring Autograft versus Patellar Tendon Autograft for ACL Reconstruction: Is There a Difference in Graft Failure Rate? A Meta-analysis of 47,613 Patients. Clin Orthop Relat Res. 2017 Oct;475(10):2459-2468. doi: 10.1007/s11999-017-5278-9.
PubMed 28205075Getgood A, Hewison C, Bryant D, Litchfield R, Heard M, Buchko G, Hiemstra LA, Willits KR, Firth A, MacDonald P; Stability Study Group. No Difference in Functional Outcomes When Lateral Extra-Articular Tenodesis Is Added to Anterior Cruciate Ligament Reconstruction in Young Active Patients: The Stability Study. Arthroscopy. 2020 Jun;36(6):1690-1701. doi: 10.1016/j.arthro.2020.02.015. Epub 2020 Mar 6.
PubMed 32147485Zaffagnini S, Marcheggiani Muccioli GM, Grassi A, Roberti di Sarsina T, Raggi F, Signorelli C, Urrizola F, Spinnato P, Rimondi E, Marcacci M. Over-the-top ACL Reconstruction Plus Extra-articular Lateral Tenodesis With Hamstring Tendon Grafts: Prospective Evaluation With 20-Year Minimum Follow-up. Am J Sports Med. 2017 Dec;45(14):3233-3242. doi: 10.1177/0363546517723013. Epub 2017 Sep 18.
PubMed 28922015Xie X, Xiao Z, Li Q, Zhu B, Chen J, Chen H, Yang F, Chen Y, Lai Q, Liu X. Increased incidence of osteoarthritis of knee joint after ACL reconstruction with bone-patellar tendon-bone autografts than hamstring autografts: a meta-analysis of 1,443 patients at a minimum of 5 years. Eur J Orthop Surg Traumatol. 2015 Jan;25(1):149-59. doi: 10.1007/s00590-014-1459-3. Epub 2014 Apr 21.
PubMed 24748500Mouarbes D, Menetrey J, Marot V, Courtot L, Berard E, Cavaignac E. Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Outcomes for Quadriceps Tendon Autograft Versus Bone-Patellar Tendon-Bone and Hamstring-Tendon Autografts. Am J Sports Med. 2019 Dec;47(14):3531-3540. doi: 10.1177/0363546518825340. Epub 2019 Feb 21.
PubMed 30790526Chen H, Liu H, Chen L. Patellar Tendon Versus 4-Strand Semitendinosus and Gracilis Autografts for Anterior Cruciate Ligament Reconstruction: A Meta-analysis of Randomized Controlled Trials With Mid- to Long-Term Follow-Up. Arthroscopy. 2020 Aug;36(8):2279-2291.e8. doi: 10.1016/j.arthro.2020.04.024. Epub 2020 May 7.
PubMed 32387652Curado J, Hulet C, Hardy P, Jenny JY, Rousseau R, Lucet A, Steltzlen C, Morin V, Grimaud O, Bouguennec N, Pujol N, Sonnery-Cottet B, Graveleau N; French Society for Orthopaedic, Trauma Surgery (Societe francaise de chirurgie orthopedique et traumatologique, SoFCOT). Very long-term osteoarthritis rate after anterior cruciate ligament reconstruction: 182 cases with 22-year' follow-up. Orthop Traumatol Surg Res. 2020 May;106(3):459-463. doi: 10.1016/j.otsr.2019.09.034. Epub 2020 Feb 1.
PubMed 32019734Zaffagnini S, Marcacci M, Lo Presti M, Giordano G, Iacono F, Neri MP. Prospective and randomized evaluation of ACL reconstruction with three techniques: a clinical and radiographic evaluation at 5 years follow-up. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1060-9. doi: 10.1007/s00167-006-0130-x. Epub 2006 Aug 15.
PubMed 16909301
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Clinical and Radiographical Outcomes of Different Anterior Cruciate Ligament Reconstruction Techniques
- ClinicalTrials.gov ID
- NCT05088278
- Acronym / sponsor ID
- Long term ACLR
- Keywords
- anterior cruciate ligament, knee osteoarthritis, hamstrings, patellar tendon, lateral extra articular tenodesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 21 Oct 2021 (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 evaluate the long-term results of various anterior cruciate ligament reconstruction techniques. This assessment is necessary for the current context of anterior cruciate ligament research as several techniques and grafts are used in clinical practice, however, the various studies existing in the literature focus mainly only on the direct comparison of two techniques and usually with short-to-medium term follow-up. Since gonarthrosis is one of the most debated consequences of cruciate ligament reconstruction, a comparison of different long-term procedures would be desirable to have a clearer picture of the risks and benefits associated with different types of intervention.
Detailed description
In the beginning, the Database of our Institute is consulted, all the patients that underwent ACL reconstruction at least 15 years ago are selected. The original group will be divided into subgroups based on the surgical technique adopted, of the different techniques we took into consideration only these three: anatomical ACL reconstruction with patellar tendon, anatomical ACL reconstruction with hamstrings, non-anatomical ACL reconstruction "Over-the-top plus lateral plasty". The patients will be contacted to ask if they are interested to take part in the study; at least 25 patients for each group will be recruited. All the patients recruited will sign an informed consent about the study and the personal data treatment. After consent acquisition, patients will undergo a clinical examination and a questionnaire about pain and knee status will be administered; moreover, a radiographical examination of the operated knee will be performed to assess the osteoarthritis progression. Patients that reported graft rupture will be registered as failures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HS | Active comparator | Procedure: Anatomical single bundle ACL reconstruction with hamstringsPatients who underwent anatomical single-bundle ACL reconstruction with hamstrings |
| BPT | Active comparator | Procedure: Anatomical single bundle ACL reconstruction with patellar tendonPatients who underwent anatomical single-bundle ACL reconstruction with patellar tendon |
| Over-the-top plus lateral plasty | Experimental | Procedure: ACL reconstruction with over the top plus lateral plasty techniquePatients who underwent ACL reconstruction with Over-the-top plus lateral plasty technique |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent ACL reconstruction with single-bundle anatomical technique (patellar tendon, semitendinous and gracile tendons) or "Over-The-Top plus lateral plastic" technique and any associated procedures with at least 15 years of follow up;
- Patients aged between 15 and 50 at the time of surgery;
- Patients with isolated ACL tear;
- Patients with healthy contralateral knee at the time of surgery.
Key exclusion criteria (4 listed)
- Patients with grade III-IV chondral lesions according to Outerbridge scale at surgery;
- Patients no longer available;
- Women of childbearing age who cannot exclude pregnancy;
- Patients unable to give informed consent or patients unwilling to sign informed consent.
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 |
|---|---|---|
| Anatomical single bundle ACL reconstruction with hamstringsAnatomical ACL reconstruction with quadruple-bundle hamstrings graft | Procedure or surgery | HS |
| Anatomical single bundle ACL reconstruction with patellar tendonAnatomical single bundle ACL reconstruction with patellar tendon | Procedure or surgery | BPT |
| ACL reconstruction with over the top plus lateral plasty techniqueNon-anatomical ACL reconstruction, the hamstrings' tibial insertion is preserved; a double-bundle hamstring graft is passed intra-articularly, fixed in over the top position on the lateral femoral condyle, and then passed extra-articularly deeply to ileo-tibial band up to the tibia, where it is fixed at the level of Gerdy's tubercle. | Procedure or surgery | Over-the-top plus lateral plasty |
Primary outcome
Subjective and objective International Knee Documentation Committee
Time frame: Two years
Clinical scores widely used to assess knee function and symptoms Values: 0 (worst score) to 100 (best score) for subjective IKDC; A (best score)-B-C-D (worst score) for objective IKDC (International Knee Documentation Committee)
VAS pain
Time frame: Two years
Numerical score to quantitatively assess the intensity of pain (0-10)
Kellgreen-Lawrence
Time frame: Two years
Radiographical score that graded knee ostheoarthritis
Knee Laxity
Time frame: Two years
Assessment of knee anterior posterior laxity and quantification of Pivot shift using measurement devices (KT-1000; Kira)
Failure and complications
Time frame: Two years
Failures and complication rate for each arm of the study
6 secondary outcomes
Short Form-36 Health Survey
Time frame: Two years
Anterior knee pain
Time frame: Two years
Global satisfaction about the surgical procedure
Time frame: Two years
Tight circumference
Time frame: Two years
Lysholm knee scoring scale
Time frame: Two years
Tegner activity scale
Time frame: Two years
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 28 Jul 2023.
- Background: PubMed 28205075Samuelsen BT, Webster KE, Johnson NR, Hewett TE, Krych AJ. Hamstring Autograft versus Patellar Tendon Autograft for ACL Reconstruction: Is There a Difference in Graft Failure Rate? A Meta-analysis of 47,613 Patients. Clin Orthop Relat Res. 2017 Oct;475(10):2459-2468. doi: 10.1007/s11999-017-5278-9.
- Background: PubMed 32147485Getgood A, Hewison C, Bryant D, Litchfield R, Heard M, Buchko G, Hiemstra LA, Willits KR, Firth A, MacDonald P; Stability Study Group. No Difference in Functional Outcomes When Lateral Extra-Articular Tenodesis Is Added to Anterior Cruciate Ligament Reconstruction in Young Active Patients: The Stability Study. Arthroscopy. 2020 Jun;36(6):1690-1701. doi: 10.1016/j.arthro.2020.02.015. Epub 2020 Mar 6.
- Background: PubMed 28922015Zaffagnini S, Marcheggiani Muccioli GM, Grassi A, Roberti di Sarsina T, Raggi F, Signorelli C, Urrizola F, Spinnato P, Rimondi E, Marcacci M. Over-the-top ACL Reconstruction Plus Extra-articular Lateral Tenodesis With Hamstring Tendon Grafts: Prospective Evaluation With 20-Year Minimum Follow-up. Am J Sports Med. 2017 Dec;45(14):3233-3242. doi: 10.1177/0363546517723013. Epub 2017 Sep 18.
- Background: PubMed 24748500Xie X, Xiao Z, Li Q, Zhu B, Chen J, Chen H, Yang F, Chen Y, Lai Q, Liu X. Increased incidence of osteoarthritis of knee joint after ACL reconstruction with bone-patellar tendon-bone autografts than hamstring autografts: a meta-analysis of 1,443 patients at a minimum of 5 years. Eur J Orthop Surg Traumatol. 2015 Jan;25(1):149-59. doi: 10.1007/s00590-014-1459-3. Epub 2014 Apr 21.
- Background: PubMed 30790526Mouarbes D, Menetrey J, Marot V, Courtot L, Berard E, Cavaignac E. Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Outcomes for Quadriceps Tendon Autograft Versus Bone-Patellar Tendon-Bone and Hamstring-Tendon Autografts. Am J Sports Med. 2019 Dec;47(14):3531-3540. doi: 10.1177/0363546518825340. Epub 2019 Feb 21.
- Background: PubMed 32387652Chen H, Liu H, Chen L. Patellar Tendon Versus 4-Strand Semitendinosus and Gracilis Autografts for Anterior Cruciate Ligament Reconstruction: A Meta-analysis of Randomized Controlled Trials With Mid- to Long-Term Follow-Up. Arthroscopy. 2020 Aug;36(8):2279-2291.e8. doi: 10.1016/j.arthro.2020.04.024. Epub 2020 May 7.
- Background: PubMed 32019734Curado J, Hulet C, Hardy P, Jenny JY, Rousseau R, Lucet A, Steltzlen C, Morin V, Grimaud O, Bouguennec N, Pujol N, Sonnery-Cottet B, Graveleau N; French Society for Orthopaedic, Trauma Surgery (Societe francaise de chirurgie orthopedique et traumatologique, SoFCOT). Very long-term osteoarthritis rate after anterior cruciate ligament reconstruction: 182 cases with 22-year' follow-up. Orthop Traumatol Surg Res. 2020 May;106(3):459-463. doi: 10.1016/j.otsr.2019.09.034. Epub 2020 Feb 1.
- Results publication: PubMed 16909301Zaffagnini S, Marcacci M, Lo Presti M, Giordano G, Iacono F, Neri MP. Prospective and randomized evaluation of ACL reconstruction with three techniques: a clinical and radiographic evaluation at 5 years follow-up. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1060-9. doi: 10.1007/s00167-006-0130-x. Epub 2006 Aug 15.
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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.
Stefano Zaffagnini, MD Prof principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomical single bundle ACL reconstruction with hamstrings, Anatomical single bundle ACL reconstruction with patellar tendon and ACL reconstruction with over the top plus lateral plasty technique in people with Anterior Cruciate Ligament Tear and Osteoarthritis, Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 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 28 Jul 2023. 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 Italy. 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?
Subjective and objective International Knee Documentation Committee (time frame: Two years). The study lists 5 primary outcomes in all. 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 NCT05088278, which also lists 8 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 28 Jul 2023.